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Impact of Oral Nutritional Supplementation in Chronic Kidney Disease Patients on Maintenance Hemodialysis: An Open-label, Single-arm Study among Indian Patients
Abstract
Background: Protein-energy wasting (PEW) affects about 50-75% of patients with chronic kidney disease (CKD), particularly those who are on maintenance hemodialysis (MHD). This study evaluated the efficacy and tolerability of an oral nutritional supplement in Indian patients receiving MHD. Materials and methods: This was a 3-month, prospective, open-label, and single-centered study. Eligible participants supplemented their regular diet with one sachet (40 gm) of oral nutritional supplement powder twice daily for 90 days. The study efficacy endpoints were mean change in acute phase proteins (albumin and prealbumin), anthropometric measurements [weight, body mass index (BMI), and triceps skin fold thickness], handgrip strength, hemoglobin, total iron binding capacity (TIBC), potassium, and phosphorus levels, malnutrition score (MS)-modified subjective global assessment (modified SGA), malnutrition inflammation score (MIS), and nutritional status. Results: The study population comprised 36 (42.9%) men and 48 (57.1%) women with a mean age of 54.85 ± 15.50 years. A paired sample t-test was used to compare the baseline with end-of-study values for continuous variables. Serum albumin, prealbumin, hemoglobin, and phosphorus levels remained stable throughout the study period. The mean change in weight, BMI, triceps skin fold thickness, handgrip strength, and TIBC for the overall study population was 1.11 kg (1.82%, p < 0.0001), 0.46 kg/m 2 (1.98%, p < 0.0001), 3.47 mm (30.78%, p < 0.0001), 6.05 kg (44.98%, p < 0.0001) and 11.80 µg/dL (6.06%, p < 0.0001), respectively. At the end of the study period, there was a significant (p < 0.0001) improvement in the SGA and MIS scores. Further, there was a significant improvement in nutritional status as demonstrated by the overall intake of calories (p < 0.001), proteins (p < 0.0001), carbohydrates (p = 0.003, and fats (p < 0.0001). Conclusion: Protein-energy malnutrition is a strong predictor of morbidity, mortality, and poor outcomes in CKD patients. A scientifically designed formula in accordance with KDOQI standards was able to improve the nutritional status, overall body composition, sarcopenia, and quality of life in CKD patients on MHD.
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Background and aims
Patients on hemodialysis (HD) or peritoneal dialysis (PD) often have insufficient energy and protein intake, resulting in poor nutritional status and adverse outcomes. Oral nutritional supplements (ONSs) are the most commonly used to increase such patients’ energy and protein intakes.
Methods
In this systematic review and meta-analysis, we analyzed studies on nutritional status, inflammatory markers, and electrolyte levels in patients on dialysis receiving ONSs. We searched four electronic databases from inception until December 31, 2022, for randomized controlled trials comparing ONS treatment versus placebo or routine care.
Results
22 studies with 1185 patients on dialysis were included in our meta-analysis. Compared with the control group, the ONS group exhibited significantly increased serum albumin levels [1.26 g/L (95%CI, 0.50–2.02, p < 0.0001; I2 = 80.4%)], body mass indexes (BMIs) [0.30 kg/m2 (95%CI, 0.09–0.52, p = 0.005; I2 = 41.4%)], and handgrip strength (HGS) [0.96 kg (95%CI, 0.07–1.84, p = 0.034; I2 = 41.4%)] from baseline to the end of intervention. No significant differences were observed between the groups in lean body mass, phase angle, C-reactive protein, and serum phosphorus and potassium levels. In terms of improving albumin, the subgroup analyses show that ONS use seems to be more inclined to three variations: HD patients, short-term use, and non-intradialytic supplementation.
Conclusion
In conclusion, ONS use can improve the nutritional status of patients on dialysis in terms of their serum albumin, BMI, and HGS without significant effects on serum phosphorus, potassium, and C-reactive protein levels. However, it remains uncertain whether these results translate to improvement in clinically relevant outcomes. Large-scale high-quality studies are still required in this population.
Background and objectives
Malnutrition is prevalent in chronic hemodialysis (HD) patients. It increases mortality and negatively affects quality of life. This study aimed to assess the effect of intradialytic oral nutritional supplement (ONS) on nutritional markers in chronic HD patients with protein energy wasting (PEW).
Methods
This 3-month prospective, open-label, randomized controlled trial included 60 chronic HD patients with PEW. The intervention group (30 patients) received intradialytic ONS and dietary counseling, whereas the control group (30 patients) received only dietary counseling. Nutritional markers were measured at the beginning and end of the study.
Results
The mean age of the patients was 54 ± 12.7 years, and that of the HD vintage was 64 ± 49.3 months. Compared to the control group, the intervention group showed a significant increase in serum albumin (p < 0.001), prealbumin (p < 0.001), cholesterol (p = 0.016), body mass index (BMI) (p = 0.019), serum creatinine/body surface area (BSA) (p = 0.016), and composite French PEW score (p = 0.002), as well as a significant decrease in high-sensitivity C-reactive protein (hs-CRP) (p = 0.001). The total iron binding capacity, normalized protein nitrogen appearance, and hemoglobin levels increased significantly in both groups.
Conclusion
Intradialytic ONS and dietary counseling for three months were more effective than dietary counseling alone in terms of improving nutritional status and inflammation in chronic HD patients, as evidenced by increases in serum albumin, prealbumin, BMI, serum creatinine/BSA, composite French PEW score, and a decrease in hs-CRP.
Objective:
To better define the prevalence of protein-energy wasting (PEW) in kidney disease is poorly defined.
Methods:
We performed a meta-analysis of PEW prevalence from contemporary studies including more than 50 subjects with kidney disease, published during 2000-2014 and reporting on PEW prevalence by subjective global assessment or malnutrition-inflammation score. Data were reviewed throughout different strata: (1) acute kidney injury (AKI), (2) pediatric chronic kidney disease (CKD), (3) nondialyzed CKD 3-5, (4) maintenance dialysis, and (5) subjects undergoing kidney transplantation (Tx). Sample size, period of publication, reporting quality, methods, dialysis technique, country, geographical region, and gross national income were a priori considered factors influencing between-study variability.
Results:
Two studies including 189 AKI patients reported a PEW prevalence of 60% and 82%. Five studies including 1776 patients with CKD stages 3-5 reported PEW prevalence ranging from 11% to 54%. Finally, 90 studies from 34 countries including 16,434 patients on maintenance dialysis were identified. The 25th-75th percentiles range in PEW prevalence among dialysis studies was 28-54%. Large variation in PEW prevalence across studies remained even when accounting for moderators. Mixed-effects meta-regression identified geographical region as the only significant moderator explaining 23% of the observed data heterogeneity. Finally, two studies including 1067 Tx patients reported a PEW prevalence of 28% and 52%, and no studies recruiting pediatric CKD patients were identified.
Conclusion:
By providing evidence-based ranges of PEW prevalence, we conclude that PEW is a common phenomenon across the spectrum of AKI and CKD. This, together with the well-documented impact of PEW on patient outcomes, justifies the need for increased medical attention.
Background/objective
This systematic review aims to determine the potential effects of oral nutritional supplements (ONS) in patients receiving maintenance dialysis therapy (MDT).
Methods
Electronic databases were searched without language limits through to July 2018. Randomized controlled trials (RCTs) that involved comparisons of ONS versus placebo or routine care are included in this meta-analysis. RevMan 5.3 statistical software was used for meta-analysis.
Results
15 articles with 589 subjects were included in our study. There are insufficient comparable data of randomized trials to allow meta-analysis of mortality. Albumin levels may be improved by the macronutrient blends or protein/amino acid supplements in MDT patients. Compared with the control group, serum albumin levels and BMI in the ONS group were increased by 1.58 g/L (95% CI, 0.52–2.63, P = 0.003; I² = 85%) and 0.40 kg/m² (95% CI, 0.10–0.71, P = 0.01; I² = 49%), respectively. In the subgroup analysis of patients receiving hemodialysis, albumin levels in ONS group were increased by 2.17 g/L (95% CI, 0.89–3.45, P<0.001; I² = 90%). ONS may not influence serum phosphorus and potassium levels.
Conclusions
Very low-quality evidence suggests that Short-term oral energy or protein/amino acid supplements may improve nutritional status by increasing serum albumin levels and BMI in MDT patients, without influence on serum potassium levels. High-quality and large RCTs, particularly regarding the effects of ONS on mortality and quality of life, are needed to further validate our findings.
Despite the continuous improvement of dialysis technology and pharmacological treatment, mortality rates for dialysis patients are still high. A 2-year prospective study was conducted at a tertiary care hospital to determine the factors influencing survival among patients on maintenance hemodialysis. 96 patients with end-stage renal disease surviving more than 3 months on hemodialysis (8-12 h/week) were studied. Follow-up was censored at the time of death or at the end of 2-year study period, whichever occurred first. Of the 96 patients studied (mean age 49.74 ± 14.55 years, 75% male and 44.7% diabetics), 19 died with an estimated mortality rate of 19.8%. On an age-adjusted multivariate analysis, female gender and hypokalemia independently predicted mortality. In Cox analyses, patient survival was associated with delivered dialysis dose (single pool Kt/V, hazard ratio [HR] =0.01, P = 0.016), frequency of hemodialysis (HR = 3.81, P = 0.05) and serum albumin (HR = 0.24, P = 0.005). There was no significant difference between diabetes and non-diabetes in relation to death (Relative Risk = 1.109; 95% CI = 0.49-2.48, P = 0.803). This study revealed that mortality among hemodialysis patients remained high, mostly due to sepsis and ischemic heart disease. Patient survival was better with higher dialysis dose, increased frequency of dialysis and adequate serum albumin level. Efforts at minimizing infectious complications, preventing cardiovascular events and improving nutrition should increase survival among hemodialysis patients.
Background:
There is no consensus on the type, time of initiation, or duration of use of enteral nutrition in patients with chronic kidney disease (CKD). This study aimed to compare the effects of a renal-specific oral nutrition supplement (RS-ONS) and a standard recommended nutrition regime on biochemical and nutrition markers in malnourished patients with CKD on hemodialysis.
Methods:
Sixty-two malnourished patients with CKD, divided into experimental (RS-ONS; n = 32; mean [SD] age, 62.0 [11.3] years; 55.2% female) and control (CON; n = 30; mean [SD] age, 57.2 [12.3] years; 31% female) groups, were evaluated for anthropometric, biochemical, and inflammatory parameters.
Results:
Mean (SD) serum albumin levels were significantly increased in the RS-ONS group from 3.5 (0.3) g/dL at baseline to 3.7 (0.2) g/dL at 6 months (P = .028). Significantly fewer patients had serum albumin levels of <3.5 g/dL after month 6. Dry weight of patients significantly increased in the RS-ONS but decreased in the CON groups (P < .001 for each). Percent change from baseline revealed negative results for bioelectrical impedance analysis (P < .001) in the CON group. Malnutrition inflammation score at 6 months (P = .006) and erythropoietin (EPO) dose requirements were higher in the CON group (P = .012).
Conclusions:
Our findings indicate that consuming RS-ONS improves serum albumin and anthropometric measures, as well as reduces EPO dose, in patients with CKD.
Protein energy wasting (PEW) is common in patients with chronic kidney disease (CKD) and is associated with adverse clinical outcomes, especially in individuals receiving maintenance dialysis therapy. A multitude of factors can affect the nutritional and metabolic status of CKD patients requiring a combination of therapeutic maneuvers to prevent or reverse protein and energy depletion. These include optimizing dietary nutrient intake, appropriate treatment of metabolic disturbances such as metabolic acidosis, systemic inflammation, and hormonal deficiencies, and prescribing optimized dialytic regimens. In patients where oral dietary intake from regular meals cannot maintain adequate nutritional status, nutritional supplementation, administered orally, enterally, or parenterally, is shown to be effective in replenishing protein and energy stores. In clinical practice, the advantages of oral nutritional supplements include proven efficacy, safety, and compliance. Anabolic strategies such as anabolic steroids, growth hormone, and exercise, in combination with nutritional supplementation or alone, have been shown to improve protein stores and represent potential additional approaches for the treatment of PEW. Appetite stimulants, anti-inflammatory interventions, and newer anabolic agents are emerging as novel therapies. While numerous epidemiological data suggest that an improvement in biomarkers of nutritional status is associated with improved survival, there are no large randomized clinical trials that have tested the effectiveness of nutritional interventions on mortality and morbidity.Kidney International advance online publication, 22 May 2013; doi:10.1038/ki.2013.147.
Serum transferrin, estimated by total iron-binding capacity (TIBC), may be a marker of protein-energy wasting (PEW) in maintenance hemodialysis (MHD) patients. We hypothesized that low TIBC or its fall over time is associated with poor clinical outcomes. In 807 MHD patients in a prospective 5-year cohort, associations of TIBC and its changes over time with outcomes were examined after adjustment for case-mix and markers of iron stores and malnutrition-inflammation including serum interleukin-6, iron and ferritin. Patients with serum TIBC >or=250 mg/dl had higher body mass index, triceps and biceps skinfolds and mid-arm muscle circumference and higher serum levels of iron but lower ferritin and inflammatory markers. Some SF-36 quality of life (QoL) components were worse in the lowest and/or highest TIBC groups. Mortality was incrementally higher in lower TIBC levels (p-trend <0.001). Adjusted death hazard ratio was 1.75 (95% CI: 1.00-3.05, p = 0.05) for TIBC <150 compared to TIBC of 200-250 mg/dl. A fall in TIBC >20 mg/dl over 6 months was associated with a death hazard ratio of 1.57 (95% CI: 1.04-2.36, p = 0.03) compared to the stable TIBC group. Hence, low baseline serum TIBC is associated with iron deficiency, PEW, inflammation, poor QoL and mortality, and its decline over time is independently associated with increased death risk.
Malnutrition, a predictor of increased mortality in dialysis patients, can be estimated using the subjective global assessment (SGA), a semiquantitative scale with three severity levels. This semiquantitative feature restricts the SGA's reliability and precision.
Using the components of the conventional SGA, we developed a fully quantitative scoring system (the dialysis malnutrition score) consisting of seven variables: weight change, dietary intake, gastrointestinal symptoms, functional capacity, comorbidity, subcutaneous fat and signs of muscle wasting. Each component was assigned a score from 1 (normal) to 5 (very severe). The sum of all seven components in this malnutrition score lies between 7 (normal) and 35 (severely malnourished). To evaluate nutritional status in chronic dialysis patients, anthropometric measurements including mid-arm circumference (MAC), triceps skin-fold thickness, calculated mid-arm muscle circumference (MAMC), body mass index (BMI, ratio of weight to square of height) and laboratory parameters were used. Forty-one patients (20 men and 21 women) were randomly selected from a pool of 120 haemodialysis patients. Patients were aged between 26 and 81 years (mean SD, 57 +/- 12 years) and had undergone haemodialysis for between 7 months and 12 years (mean +/- SD, 3.0 +/- 2.1 years).
The malnutrition score of each patient was assessed by a dietitian within 5-20 min (12.0 +/- 3.5 min) with no knowledge of anthropometric findings. Pearson correlation coefficients between the malnutrition score and biceps skin-fold (r= -0.32) MAC (r= -0.55), MAMC (r= -0.66), BMI (r= -0.35), total iron-binding capacity (TIBC, r= -0.77), the serum albumin concentration (r= -0.36) and total protein (r= -0.33) were all significant, whereas the conventional SGA had significant correlation only with TIBC (r= -0.35) and MAMC (r= -0.37). Malnutrition score showed a significant correlation with age (r= +0.34) and years dialysed (r= +0.28). Multiple regression analysis showed a significant correlation between the malnutrition score and the combination of the MAMC, BMI, serum albumin concentration and TIBC (r= 0.81, P<0.001). There was no correlation between the malnutrition score and sex, urea reduction ratio, protein catabolic rate, and the absolute lymphocyte count.
We conclude that our invented malnutrition score, which can be performed in minutes, reliably assesses the nutritional status of haemodialysis patients. We suggest that our malnutrition score may be superior to the SGA. More comparative and longitudinal studies are needed to confirm the validity of this scoring system in nutritional evaluation of dialysis patients.
Hypoalbuminaemia is a marker of malnutrition-inflammation complex syndrome (MICS) and a strong predictor of cardiovascular (CV) death in maintenance haemodialysis (MHD) patients. However, serum albumin may change over time. Hence, its time-varying associations with outcome may be different.
Associations between 3-month averaged serum albumin levels, measured in a single laboratory using bromocresol green, and CV mortality were studied longitudinally in a 2-year cohort of 58,058 MHD patients. Mortality predictability of fixed baseline and trimonthly-varying serum albumin concentrations were compared.
Hazard ratios (HRs) of CV death strictly increased across decrements of baseline serum albumin, whereas the HR for time-varying serum albumin decrements below 3.8 g/dl did not differ. A drop in serum albumin in the first 6 months was associated with increasing all-cause and CV death risks in the subsequent 18 months, while a rise in serum albumin was a predictor of better survival independent of baseline serum albumin. The multivariate adjusted population-attributable fraction of death due to baseline serum albumin <3.8 g/dl was 19%.
Time-varying hypoalbuminaemia predicts all-cause and CV death differently from fixed measures of serum albumin in MHD patients. An increase in serum albumin over time is associated with better survival independent of baseline serum albumin or other MICS surrogates. If this association is causal, an intervention that could increase serum albumin >3.8 g/dl might reduce the number of MHD deaths in the USA by approximately 10,000 annually. Nutritional interventions examining benefits of increasing serum albumin in MHD patients are urgently needed.
There is paucity of data available on how chronic kidney disease (CKD) is treated before referral to a tertiary hospital. This study was conducted to assess pre-tertiary hospital care of patients with CKD 5 at their presentation to nephrology services at a tertiary care hospital.
Over a period of 8 months, consecutive patients with CKD 5 presenting at the Nephrology services at Christian Medical College, Vellore, Tamil Nadu, and their relatives were interviewed to assess the pre-tertiary hospital care and knowledge about CKD 5 and its treatment.
A total of 561 patients with CKD 5 were enrolled. The mean duration (months) of known CKD was 12.4 +/- 23.1 and known CKD 5 was 3.2 +/- 3.5. Of these, 369 patients (65.8%) had been under the care of a nephrologist; 305 patients had CKD 5 as the initial presentation of renal illness. Vaccination against hepatitis B had been initiated in only 133 patients (23.7%). Only 172 patients(38%) had an adequately controlled blood pressure. Care under a nephrologist was more likely to result in appropriate investigation, treatment and patient education though blood pressure control did not differ.
Paucity of symptoms in the initial stages of certain forms of CKD probably led to 50 per cent of patients presenting with CKD 5 as the initial presentation of renal disease. Inadequate vaccination against hepatitis B infection highlights the need for appropriate vaccination. Prevention of CKD and its progression are important targets which requires physician awareness at all levels. Early referral to a nephrologist's care is more likely to result in appropriate investigations and treatment.
Protein-energy wasting is a frequent and debilitating condition in maintenance dialysis. We randomly tested if an energy-dense, phosphate-restricted, renal-specific oral supplement could maintain adequate nutritional intake and prevent malnutrition in maintenance haemodialysis patients with insufficient intake.
Eighty-six patients were assigned to a standard care (CTRL) group or were prescribed two 125-ml packs of Renilon 7.5(R) daily for 3 months (SUPP). Dietary intake, serum (S) albumin, prealbumin, protein nitrogen appearance (nPNA), C-reactive protein, subjective global assessment (SGA) and quality of life (QOL) were recorded at baseline and after 3 months.
While intention to treat analysis (ITT) did not reveal strong statistically significant changes in dietary intake between groups, per protocol (PP) analysis showed that the SUPP group increased protein (P < 0.01) and energy (P < 0.01) intakes. In contrast, protein and energy intakes further deteriorated in the CTRL group (PP). Although there was no difference in serum albumin and prealbumin changes between groups, in the total population serum albumin and prealbumin changes were positively associated with the increment in protein intake (r = 0.29, P = 0.01 and r = 0.27, P = 0.02, respectively). The SUPP group did not increase phosphate intake, phosphataemia remained unaffected, and the use of phosphate binders remained stable or decreased. The SUPP group exhibited improved SGA and QOL (P < 0.05).
This study shows that providing maintenance haemodialysis patients with insufficient intake with a renal-specific oral supplement may prevent deterioration in nutritional indices and QOL without increasing the need for phosphate binders.
Haemodialysis (HD) is the commonest form of kidney replacement therapy in the world, accounting for approximately 69% of all kidney replacement therapy and 89% of all dialysis. Over the last six decades since the inception of HD, dialysis technology and patient access to the therapy have advanced considerably, particularly in high-income countries. However, HD availability, accessibility, cost and outcomes vary widely across the world and, overall, the rates of impaired quality of life, morbidity and mortality are high. Cardiovascular disease affects more than two-thirds of people receiving HD, is the major cause of morbidity and accounts for almost 50% of mortality. In addition, patients on HD have high symptom loads and are often under considerable financial strain. Despite the many advances in HD technology and delivery systems that have been achieved since the treatment was first developed, poor outcomes among patients receiving HD remain a major public health concern. Understanding the epidemiology of HD outcomes, why they might vary across different populations and how they might be improved is therefore crucial, although this goal is hampered by the considerable heterogeneity in the monitoring and reporting of these outcomes across settings.
Background:
Malnutrition is common in patients with chronic kidney disease (CKD) on dialysis. Oral protein-based nutritional supplements are often provided to patients whose oral intake is otherwise insufficient to meet their energy and protein needs. Evidence for the effectiveness of oral protein-based nutritional supplements in this population is limited.
Objectives:
The aims of this review were to determine the benefits and harms of using oral protein-based nutritional supplements to improve the nutritional state of patients with CKD requiring dialysis.
Search methods:
We searched the Cochrane Kidney and Transplant Register of Studies up to 12 December 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.
Selection criteria:
Randomised controlled trials (RCTs) of patients with CKD requiring dialysis that compared oral protein-based nutritional supplements to no oral protein-based nutritional supplements or placebo.
Data collection and analysis:
Two authors independently assessed studies for eligibility, risk of bias, and extracted data from individual studies. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios and their 95% confidence intervals (CI) for dichotomous outcomes, and mean difference and 95% CI for continuous outcomes.
Main results:
Twenty-two studies (1278 participants) were included in this review. All participants were adults on maintenance dialysis of whom 79% were on haemodialysis (HD) and 21% peritoneal dialysis. The follow-up period ranged from one to 12 months. The majority of studies were at unclear risk of selection, performance, and reporting bias. The detection bias was high for self-reported outcomes. Oral protein-based nutritional supplements probably lead to a higher mean change in serum albumin compared to the control group (16 studies, 790 participants: MD 0.19 g/dL, 95% CI 0.05 to 0.33; moderate certainty evidence), although there was considerable heterogeneity in the combined analysis (I2 = 84%). The increase was more evident in HD participants (10 studies, 526 participants: MD 0.28 g/dL, 95% CI 0.11 to 0.46; P = 0.001 for overall effect) and malnourished participants (8 studies, 405 participants: MD 0.31 g/dL, 95% CI 0.10 to 0.52, P = 0.003 for overall effect). Oral protein-based nutritional supplements also probably leads to a higher mean serum albumin at the end of the intervention (14 studies, 715 participants: MD 0.14 g/dL, 95% CI 0 to 0.27; moderate certainty evidence), however heterogeneity was again high (I2 = 80%). Again the increase was more evident in HD participants (9 studies, 498 participants: MD 0.21 g/dL, 95% CI 0.03 to 0.38; P = 0.02 for overall effect) and malnourished participants (7 studies, 377 participants: MD 0.25 g/dL, 95% CI 0.02 to 0.47; P = 0.03 for overall effect). Compared to placebo or no supplement, low certainty evidence showed oral protein-based nutritional supplements may result in a higher serum prealbumin (4 studies, 225 participants: MD 2.81 mg/dL, 95% CI 2.19 to 3.43), and mid-arm muscle circumference (4 studies, 216 participants: MD 1.33 cm, 95% CI 0.24 to 2.43) at the end of the intervention. Compared to placebo or no supplement, oral protein-based nutritional supplements may make little or no difference to weight (8 studies, 365 participants: MD 2.83 kg, 95% CI -0.43 to 6.09; low certainty evidence), body mass index (9 studies, 368 participants: MD -0.04 kg/m2, 95% CI -0.74 to 0.66; moderate certainty evidence) and lean mass (5 studies, 189 participants: MD 1.27 kg, 95% CI -1.61 to 4.51; low certainty evidence). Due to very low quality of evidence, it is uncertain whether oral protein-based nutritional supplements affect triceps skinfold thickness, mid-arm circumference, C-reactive protein, Interleukin 6, serum potassium, or serum phosphate. There may be little or no difference in the risk of developing gastrointestinal intolerance between participants who received oral protein-based nutritional supplements compared with placebo or no supplement (6 studies, 426 participants: RR 2.81, 95% CI 0.58 to 13.65, low certainty evidence). It was not possible to draw conclusions about cost or quality of life, and deaths were not reported as a study outcome in any of the included studies.
Authors' conclusions:
Overall, it is likely that oral protein-based nutritional supplements increase both mean change in serum albumin and serum albumin at end of intervention and may improve serum prealbumin and mid-arm muscle circumference. The improvement in serum albumin was more evident in haemodialysis and malnourished participants. However, it remains uncertain whether these results translate to improvement in nutritional status and clinically relevant outcomes such as death. Large well-designed RCTs in this population are required.
Background:
Malnutrition is a common finding in hemodialysis patients and can increase oxidative stress and inflammation levels.
Study design:
A randomized, controlled, nonblinded, parallel trial.
Setting & participants:
92 hemodialysis patients from a single center with malnutrition according to subjective global assessment (SGA) score (SGA score > 7).
Intervention:
3 treatment groups (23 patients each) received 220mL of fermented vitamin E-fortified whey beverage (15g of whey protein concentrate + 600IU of vitamin E) or 220mL of fermented whey beverage (15g of whey protein concentrate) or vitamin E (600IU) 3 times a week for 8 weeks. The control group (23 patients) received no intervention.
Outcome & measurements:
Primary outcomes were change in SGA score and malnutrition-inflammation score (MIS) from baseline to the end of the trial.
Results:
At the end of the study, 83 patients were analyzed (2, 3, 1, and 3 patients left the study in the vitamin E-fortified whey beverage, whey beverage, vitamin E, and control groups, respectively). Changes in SGA scores were -3.48 (95% CI, -4.90 to -2.00), -3.22 (95% CI, -4.13 to -2.30), -1.70 (95% CI, -3.20 to -0.24), and 1.56 (95% CI, 0.60 to 2.50) for the vitamin E-fortified whey beverage, whey beverage, vitamin E, and control groups, respectively (overall P<0.001; P≤0.001 for each treatment group vs control). Changes in MISs were -3.17 (95% CI, -4.40 to -1.90), -1.83 (95% CI, -2.50 to -1.10), -2.30 (95% CI, -3.50 to -1.10), and 1.48 (95% CI, 0.65 to 2.30) for the vitamin E-fortified whey beverage, whey beverage, vitamin E, and control groups, respectively (overall P<0.001; P<0.001 for each treatment group vs control). Few adverse effects were reported in any group.
Limitations:
Lack of blinding, small sample size, and short duration.
Conclusions:
Whey protein in the form of a new fermented whey beverage and vitamin E supplementation may improve SGA score and MIS in the short term.
To evaluate the effects of predialytic oral nutritional supplementation in chronic kidney disease (CKD) patients on maintenance haemodialysis (MHD).
NEPRO HP was provided to 77 CKD patients on maintenance haemodialysis (MHD) over 3 months. Efficacy parameters were improvement in albumin levels, weight and haemoglobin levels; safety parameters were serum potassium and phosphorus values; other parameters were SGA and MIS scores.
Mean serum albumin values showed a statistically significant increase. There was a statistically significant improvement in the mean body weight and haemoglobin of the patients in the second and third months of treatment. Serum phosphorus and potassium levels did not change in a statistically significant manner. There was improvement in nourishment status as detected by MIS and SGA scores. Two patients expired during the course of the study.
Predialytic oral supplementation with NEPRO HP improves nutritional status of CKD patients on MHD.
Background: Malnutrition is a relatively common problem in patients on hemodialysis (HD) and is associated with increased morbidity and mortality in affected patients. Many factors may contribute to malnutrition in these patients. There is no single measurement that can reliably predict the risk for malnutrition.
Aim of study: Our aim was to determine the risk of malnutrition among hemodialysis (HD) patients in Merjan hospital / dialysis center in Iraq by using modified subjective global assessment, and to examine the relationship between various nutritional and non-nutritional factorsin those patients.
Patients and method: Cross-sectional study was undertaken in Merjan hospital dialysis center in Babylon during the period from 1st of March to 30 of June 2013. Seventy five participants diagnosed with end-stage renal failure (ESRD) were enrolled. These participants who underwent hemodialysis treatment were recruited using a convenience sampling technique. Modified Subjective global assessment (m-SGA), anthropometry, and biochemical measurements were used as evaluative tools.
Results: Nutritional status of the patients was assessed. Mean age of the study population was 51.16 ± 15.03years. Males were older than females. The mean of malnutrition score was 18.61 ± 6.17. This study shows that 32% of our patients were diabetic, while 68% of them were hypertensive; about 68% of those patients had dialysis in frequency of twice per week. Based on MS, (71%) had mild to moderate malnutrition, (23%) patients were having severe malnutrition and remaining (6%) had normal nutrition score. There was no significance of the nutritional status with age, sex, occupation or smoking habit, while there was significance with residence of patients, cause of renal failure and frequency of dialysis that our patients had regarding the laboratory investigation, nutritional status show significance only with serum albumin, and serum phosphate. 99% of our patients were anemic. The anthropometric measurements done were basal metabolic rate BMI, waist / hip ratio W/H ratio, mid arm circumference MAC. The nutritional status was significant with the mid arm circumference MAC, while there was no significance between nutritional status and basal metabolic rate BMI, and waist / hip ratio W/H ratio . 1.4
Conclusions: The frequency of malnutrition is high among patients in our dialysis center, mostly the mild to moderate malnutrition.Most of our patients on maintenance hemodialysis had nutritional problem.
Protein-energy wasting (PEW), which is manifested by low serum levels of albumin or prealbumin, sarcopenia and weight loss, is one of the strongest predictors of mortality in patients with chronic kidney disease (CKD). Although PEW might be engendered by non-nutritional conditions, such as inflammation or other comorbidities, the question of causality does not refute the effectiveness of dietary interventions and nutritional support in improving outcomes in patients with CKD. The literature indicates that PEW can be mitigated or corrected with an appropriate diet and enteral nutritional support that targets dietary protein intake. In-center meals or oral supplements provided during dialysis therapy are feasible and inexpensive interventions that might improve survival and quality of life in patients with CKD. Dietary requirements and enteral nutritional support must also be considered in patients with CKD and diabetes mellitus, in patients undergoing peritoneal dialysis, renal transplant recipients, and in children with CKD. Adjunctive pharmacological therapies, such as appetite stimulants, anabolic hormones, and antioxidative or anti-inflammatory agents, might augment dietary interventions. Intraperitoneal or intradialytic parenteral nutrition should be considered for patients with PEW whenever enteral interventions are not possible or are ineffective. Controlled trials are needed to better assess the effectiveness of in-center meals and oral supplements.
Although serum prealbumin is considered a valid indicator of nutritional status in hemodialysis patients, there is relatively little evidence that its determination is of major prognostic significance. In this study, we aimed to determine the independent association of serum prealbumin with survival in hemodialysis patients, after adjusting for serum albumin and other indicators of protein energy nutritional status.
Serum prealbumin was measured in more than 1600 maintenance hemodialysis patients. We determined the correlations among prealbumin and other indicators of nutritional status, including serum albumin, and bioimpedance-derived indicators of body composition. The relationship between serum prealbumin and survival was determined using proportional hazards regression.
The serum albumin was directly correlated with the serum prealbumin (r = 0.47, P < 0.0001), but still explained <25% of the variability in prealbumin. Prealbumin was inversely related to mortality, with a relative risk reduction of 6% per 1 mg/dL increase in prealbumin, even after adjusting for case mix, serum albumin, and other nutritional indicators. The increase in risk with lower serum prealbumin concentrations was observed whether the serum albumin was high or low.
In hemodialysis patients, the serum prealbumin provides prognostic value independent of the serum albumin and other established predictors of mortality in this population.
This controlled trial was undertaken to evaluate the benefits of short-term enteral nutrient supplementation in maintenance hemodialysis (MHD) patients using a high-calorie and high-protein blend formula (low-cost home-prepared [HP] blend or a commercially available supplement) and to study its effect on selected parameters of nutritional status. The acceptability and palatability of the HP blend formula, ease of use, and cost were also assessed in comparison with the commercial nutritional supplement (CNS).
Randomized controlled trial.
Hemodialysis (HD) unit of a tertiary referral care hospital in Southern India.
Nondiabetic adult MHD patients with no intercurrent illness, on regular thrice weekly MHD for at least 1 month before recruitment, with a body mass index (BMI) <20 and a serum albumin level of <4.0 g/dL. Patients were randomized into control group and experimental group, the latter in turn to recieve either CNS or HP blend.
The control group received appropriate monitoring, including dietary recall and counselling for the prescribed diet (protein intake of 1.2 g/kgIBW/d and energy of 35 to 45 kcal/kgIBW/d) but no specific post-HD supplement. Patients in the supplement group received the respective supplement post-HD (providing 500 kcal and 15 g protein) for 1 month in addition to the monitored diet prescription. Main Outcome Measures: (1) Nutritional status parameters, BMI and serum albumin; (2) functional status on a 10-point Karnofsky scale; (3) adverse metabolic effects, hyperphosphatemia at start and end of study; and (4) subjective scoring for appetite, and acceptability of and tolerance to supplement.
Both groups showed an improvement in dry weight and BMI. In addition, the supplement group showed a significant increase in serum albumin level and functional scoring. Mild hyperphosphatemia occurred in the supplement group. An increase in baseline food intake was seen in the control group, but not in the supplemented group. No intolerance was reported to either supplement.
Enteral nutrient supplementation was shown to bring about a significant improvement in serum albumin level even in a short-term study. Use of an HP supplement was beneficial, acceptable, and inexpensive.
Prospective evaluation of the effect of 6-month-long intradialytic amino acids (AA) supplementation on selected nutritional variables in malnourished hemodialysis (HD) patients.
Multicenter, prospective, (nonrandomized, noncontrolled) observational study.
Thirty-one HD units affiliated with academic centers and tertiary-care hospitals.
Adult patients treated by HD for at least 6 months. Inclusion criteria were: serum albumin concentration < or =39 g/L and at least 4% loss of body weight during the last 6 months in otherwise stable HD patients. From a cohort of 133 patients who were enrolled, 97 (54 men and 43 women) were eligible for the analysis.
Intradialytic AA supplementation with 500 mL 10% solution per HD session for a period of 6 months.
Serum albumin concentration, modified Subjective Global Assessment (SGA) score, body mass index (BMI), mid-arm circumference (MAC), and total lymphocyte count. Measurements were recorded at baseline and after 3 and 6 months of AA supplementation.
Serum albumin concentration increased significantly from the mean 32.5 +/- 4.6g/L at baseline to 36.4 +/- 4.8 g/L at 3 months (P <.001) and 37.1 +/- 4.8 g/L at final observation (P <.001 versus baseline). Significant correlation was observed between frequency of AA supplementation and serum albumin increase (r = 0.41; P <.0001). Rate of improvement negatively correlated significantly with baseline concentration of serum albumin (r = - 0.42; P <.0001). SGA score significantly improved from median of 16 points at baseline to 12 points at 3 months (P <.01) and 11 points at 6 months (P <.01 versus baseline), and this improvement also correlated with the frequency of AA supplementation. Small yet significant increase of MAC was observed at 6 months (from baseline 24.1 +/- 4.3 to 24.8 +/- 4.8 cm; P <.01), whereas BMI remained unchanged.
Intradialytic AA supplementation improves selected nutritional parameters of HD patients with malnutrition. The improvement depends on the intensity of supplementation.
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