New solutions for peritoneal dialysis in adult and pediatric patients.
ABSTRACT The standard PD solutions used today contain physiological electrolyte profiles similar to that of interstitial fluids and are supplemented with glucose as the osmotic agent. Improvements in solution composition during the last 20 years have been largely restricted to minor changes in buffer and electrolyte levels. Newer PD solutions, on the other hand, are designed to manage comorbidities associated with patients on maintenance dialysis, to tailor the ultrafiltration profile based upon dwell time, and to better preserve peritoneal membrane function and host defenses. The evidence to date indicates that, in malnourished PD patients (children and adults), IP amino acids improve protein nutritional status, particularly if low protein intakes are a cause of the malnutrition. The availability of glucose polymers allows the clinician to complement standard glucose-based formulations with one that can provide improved ultrafiltration in both CAPD and APD patients for long dwells, and in patients experiencing ultrafiltration loss owing to a large effective peritoneal surface area. Owing to the reduced calorie and carbohydrate load, glucose polymers may also offer long-term metabolic advantages. Although the control of acid-base balance can be well managed in the vast majority of patients with a 35-40 mmol/L lactate solution, the development and clinical evaluation of bicarbonate-based solutions is underway as a result of concern over the potentially bioincompatible nature of acidic lactate formulations. To date, in vitro, ex vivo, and limited clinical studies show that such formulations, and in particular bicarbonate/lactate combinations are efficacious and well tolerated, and show improved peritoneal cell function versus conventional solutions. In conclusion, ongoing research and development has produced a new generation of PD solutions that, to various degrees, meet different criteria established for an ideal PD solution for chronic adult and pediatric patients on PD. These criteria include good clearance and ultrafiltration, supply of nutrition, iso-osmolality, physiologic pH, bicarbonate buffer, and minimal absorption of the osmotic agent. Several of the new solutions have already demonstrated clinical utility in controlled clinical trials and are commercially available in Europe. Wider clinical use will further add to our understanding of the impact of these formulations on patient outcomes.
- [show abstract] [hide abstract]
ABSTRACT: This study revealed the following. Malnutrition was frequent (41.6%) in patients on CAPD for less than three months and was present in 18.1% of patients on CAPD for longer than 3 months. Fifty percent of these malnourished patients returned to normal on conventional nutritional management within 2 to 6 months, but 10% remained malnourished throughout the study period. There was increased mortality among malnourished patients, but we were unable to demonstrate that the state of nutrition was an independent risk factor, because of the increased prevalence of other co-morbid risk factors known to influence survival and because of the limitation of a small sample size. The influence, if any, of nutritional state as an independent risk factor on the survival of CAPD patients should be answered, because malnutrition is potentially reversible with aggressive nutritional interventions, such as enteral, parenteral, or intraperitoneal supplementation.ASAIO transactions / American Society for Artificial Internal Organs 33(3):650-3.
- [show abstract] [hide abstract]
ABSTRACT: We examined the nutritional status of 224 patients from six centers in Europe and North America to assess the incidence of protein-energy malnutrition. A "subjective nutritional assessment" was made, using 21 variables derived from history and clinical examination, or anthropometry and biochemistry. Eighteen patients (8%) were severely malnourished, 73 (32.6%) were mildly to moderately malnourished, and 133 (59.4%) did not show evidence for malnutrition. There was a higher incidence of mild to moderate malnutrition in diabetics than in nondiabetics. A statistical analysis identified 12 variables, seven objective and five subjective, that correlated with subjective nutritional assessment. Actual intercenter differences for the incidence of malnutrition were related to patient age, nutritional status at the commencement of continuous ambulatory peritoneal dialysis (CAPD), the length of time on CAPD, and residual renal function. Variables that were most frequently correlated with subjective nutritional assessment and with one another included plasma albumin, mid-arm muscle circumference (MAMC), weight loss, and the clinical judgement of muscle wasting and loss of subcutaneous fat. Loss of residual renal function correlated with muscle wasting and months on CAPD. Our data identified differences between the two sexes. In women there was a trend for more anorexia, greater weight loss from muscle wasting, and a larger decrease in albumin, whereas in men there was a more gradual decrease in nutritional status. Loss of residual renal function contributed to anorexia and symptoms of severe malnutrition.American Journal of Kidney Diseases 05/1991; 17(4):462-71. · 5.29 Impact Factor
- [show abstract] [hide abstract]
ABSTRACT: In a cross-sectional study, the nutritional status of 32 patients on hemodialysis (HD) and 16 patients on peritoneal dialysis (CAPD) was determined. Protein-caloric malnourishment assessed from a score system based on triceps skin-fold, midarm muscle circumference, S-transferrin and relative body weight was recorded in 54% of the patients. No significant differences between the nutritional status of HD and CAPD patients were found. Malnutrition was more frequent among patients in early stage dialysis (i.e., dialysis for less than 12 months) than among other patients (p less than 0.02). Frequent assessment of the nutritional status is mandatory for optimal nourishment.Clinical nephrology 03/1988; 29(2):75-8. · 1.29 Impact Factor
Proceedings of the ISPD .98 The VIIIth Congress of the ISPD
August 23 -26, 1998. Seoul. Korea
Peritoneal Dialysis International, Vol.19 (1999), Supplement 2
0896-8608/99 $300 + 00
Copyright © 1999 International Society for Peritoneal Dialysis
Printed in Canada All rights reserved
NEW SOLUTIONS FOR PERITONEAL DIALYSIS
IN ADULT AND PEDIATRIC PATIENTS
Ty R. Shockley,1 Leo Martis,1 Anders P. Tranæus2
Renal Division,1 Baxter Healthcare, McGaw Park, Illinois, U.S.A. and Baxter World Trade S.A.,2 Evère, Brussels, Belgium
major advantages of glucose are that it produces high
ultrafiltration rates at relatively low mass concentrations; it
is readily metabolized; it is safe; and it has beneficial
nutritional value, especially for patients with poor calorie
intake. Glucose-containing solutions are also relatively
inexpensive and easy to manufacture. The major drawbacks
of glucose as an osmotic agent include inadequate
ultrafiltration during long-dwell exchanges, particularly in
patients with high peritoneal permeability; worsening of
metabolic abnormalities owing to the peritoneal glucose
load; and potential local adverse effects in the peritoneum
owing to the bioincompatible aspects of standard lactate-
buffered PD solutions.
Because of the drawbacks, which are indeed applicable
in adult patients as well as in pediatric patients, there has
been continued research and development ofnew PD
solutions. Efforts have been focused mainly on three areas.
The first area is the replacement of glucose with equally
small molecular weight substances, such as amino acids, to
alter the metabolic profile. The second area is the
replacement of glucose with large molecular weight
substances such as glucose polymers to enhance
ultrafiltration while minimizing absorption of the osmotic
agent, thereby reducing metabolic side effects. The final
area is providing PD solutions that contain bicarbonate as a
buffer and that are thus pH-neutral, with improved
biocompatibility profiles. This paper will focus on clinical
experience with these three new commercially available
lucose is almost universally used as an osmotic agent
in peritoneal dialysis (PD) solutions. The
KEYWORDS: Peritoneal dialysis solutions; amino
acids; glucose polymer; icodextrin; bicarbonate.
Correspondence to: A.P. Tranæus, Baxter World
Trade S.A., Rue Colonel Bourg., 105B, B-1140
Evère, Brussels, Belgium.
AMINO ACID-CONTAINING PD SOLUTIONS
The current interest in amino acids is largely due to the
presence of significant protein malnutrition in dialysis
patients (1-5) and the obligatory loss ofproteins and amino
acids in peritoneal effluents (6).
Amino acids are small molecular weight solutes ranging
from 75 204 D. The osmolality of a dialysis solution
containing amino acids, therefore, is higher than that of a
glucose-based solution at equivalent concentration [weight-
to-volume percent (w/v%)]. The dialysis efficacy of amino
acid-containing PD solution is similar to that of glucose-
containing solution. For example, ultrafiltration with the
only commercially available amino acid-based (1.1 %) PD
solution (Nutrineal: Baxter Healthcare, McGaw Park,
Illinois, U.S.A.) is similar to 1.36% glucose (7). The major
limitation of amino acids as osmotic agents is that they
generate nitrogenous waste, and therefore the amount that
can be administered is limited.
A recent study (8) in 20 adult continuous ambulatory
peritoneal dialysis (CAPD) patients examined losses of
amino acids into dialysate and the absorption of amino acids
during dialysis with Nutrineal. Daily mean losses of amino
acids and total proteins totaled 9.2 ± 2.7 g. Net
absorption of amino acids during a 6-hour exchange with
Nutrineal was 17.6 ± 2.6 g (80% ± 12% of
the 22 g infused). The net absorption of amino acids from
the dialysis solution was directly correlated with the
patients' peritoneal membrane transport characteristics. The
authors concluded that the gains of amino acids absorbed
from 1 exchange per day of Nutrineal more than offset the
daily losses of amino acids and proteins into dialysate.
The effects of amino acids on nutritional status, serum
amino acids, glucose, and lipid metabolism have been
investigated in several adult populations (7,917). In most
studies, a significant increase in serum albumin and
transferrin (9,11,13,15,17), nitrogen balance (7,10,16), total
body nitrogen (13), or body weight (10,15) was reported.
On the other hand, no significant improvement in these
by on July 13, 2011
eters has also occasionally been reported (18). Interpretation
of these results is complicated by the fact that different
amino acid formulations were used, normal nutritional status
was not generally an exclusion criterion, the sample sizes
were small, and dietary intake of nutrients was often not
controlled or monitored.
In a multicenter study, the nutritional and metabolic
effects of Nutrineal were assessed in a group of CAPD
patients known to be malnourished, and in whom the
malnutrition was thought to be due, at least in part, to
inadequate protein intake (7). The study was carried out in
18 adult patients for 35 days under strict metabolic ward
conditions. Patients were given a constant diet providing 0.8
g protein per kilogram of body weight per day. Mter a
baseline period of 15 days, the amino acid solution was
substituted for lor 2 glucose exchanges, increasing the total
daily protein intake from all sources to between 1.1 g/kg and
1.3 g/kg. At baseline, patients were in neutral nitrogen
balance. Mter commencing intraperitoneal (IP) amino acid
therapy, nitrogen balance became significantly positive; a
significant increase occurred in net protein anabolism as
determined from N14-glycine studies, the fasting plasma
amino acid pattern became more normal, and serum total
protein and transferrin concentrations rose.
The more long-term (3 months) nutritional benefits of
Nutrineal have also been evaluated (12,17). These studies
have demonstrated a statistically significant rise in serum
albumin (12,17), pre-albumin (17), transferrin (17), and mid
arm muscle circumference (17) in adult patients using
Nutrineal for 3 months.
Minor episodes of nausea, vomiting, or unspecified
gastrointestinal symptoms have been reported with the use
ofNutrineal (7,17). These side effects are generally
associated with the use of multiple exchanges, and seem to
be dose-dependent. Furthermore, as expected, the use of
Nutrineal has generally led to an increase in serum urea and
a mild degree of metabolic acidosis (7,17). The acid-base
status of patients receiving Nutrineal should be monitored,
and oral alkalinizing agents such as sodium bicarbonate
should be used as needed (7,19).
In children of all age groups, the protein intake
requirements are higher than in adults. To obtain optimal
conditions for growth and development 1.5 3.0 g of protein
per kilogram of body weight daily are recommended (20).
This level is not achievable via a conventional oral intake.
Most centers, therefore, rely on enteral nutrition (tube
feeding). Today, however, the use ofIP amino acid solutions
in children has also been shown to be safe and equally
effective in achieving ultrafiltration and clearances as
compared to glucose-based solutions (21). Studies have
shown that a 1.1% solution is preferred as regards the
plasma amino acid concentrations (22). Moreover, the use of
IP amino acids in pediatric patients has been found to limit
the glucose load, to compensate for the IP losses of amino
acids, and to result in a plasma amino acid pattern that
resembles the pattern observed after a protein meal (23).
Furthermore, shortterm studies in children have indicated an
anabolic effect ofIP amino acids (24). More recently, the
longterm combined administration of glucose and amino
acid solution IP in pediatric ambulatory peritoneal dialysis
(APD) patients has demonstrated a marked positive nitrogen
ICODEXTRIN-CONTAINING PD SOLUTIONS
The use of glucose polymers as osmotic agents in PD
was first described in the early 1980s (26,27). These studies
led to the commercial development of a PD solution
containing 7.5% icodextrin, which is commercially available
in Europe (Extraneal: Baxter World Trade S.A., Brussels,
Belgium). Icodextrin is a glucose polymer with an average
molecular weight of 12,000 -20,000 D. It is obtained by
fractionation of hydrolyzed starch, and it is composed of
glucose units linked predominantly by α 1-4
glucosidic bonds (28).
In a randomized, multicenter study in 209 adult CAPD
patients over a 6-month period, 7.5% icodextrin was
demonstrated to be safe for the overnight exchange,
effectively replacing hyperosmolar glucose solutions (29).
The ultrafiltration volume was not significantly different
from 3.86% glucose during an 8 12 hour exchange, but was
3.5 -5.5 times greater than that from a 1 .36% solution. In
adult continuous cycling peritoneal dialysis patients, 7.5%
icodextrin has also been shown to produce sustained positive
ultrafiltration for up to 16 hours (30,31).
Various clinical studies suggest that icodextrinbased
solutions are especially effective during long dwells and in
patients with ultrafiltration failure owing to a large effective
peritoneal surface area (32-35). Peritonitis is associated with
ultrafiltration failure with glucose-based solutions, caused
by the increased diffusive transport rate of glucose. In this
situation, icodextrin has also been shown to generate more
ultrafiltration as compared to glucose-based solutions (36).
Icodextrin is most likely absorbed from the peritoneal
cavity via the lymphatics. The extent of absorption depends
on the dwell time: about 20% of the total carbohydrate is
absorbed in 8 hours, and this rises to 34% at 12 hours (37).
Use of icodextrin solution results in reduced carbohydrate
and calorie loads compared to high glucose solutions, and
the lack ofhyperglycemia and hyperinsulinemia associated
with its use may offer long-term metabolic advantages and
may possibly simplify management of diabetic patients (29).
by on July 13, 2011
In the systemic circulation, icodextrin is hydrolyzed to
oligosaccharides such as maltose, isomaltose, maltotriose,
and maltotetrose (37). In adult CAPD patients using 7.5%
icodextrin for 1 exchange per day, steady-state levels of
polymer and metabolites are reached in 7 10 days and have
been shown to be maintained for more than 2 years (37).
When treatment with icodextrin is stopped, and patients are
switched to glucose solutions only, plasma levels of
icodextrin and metabolites fall to normal within 7 10 days.
These results suggest that there is no capacity-Iimited deep
compartment for the storage of icodextrin in the human
As of today, no studies on the use of icodextrin in
pediatrics have been published. In particular, more data on
the metabolism of icodextrin are needed before this solution
can be further evaluated in children.
BICARBONATE-BUFFERED PD SOLUTIONS
One of the systemic abnormalities that renal replacement
therapy must address is the metabolic acidosis that occurs
with progressive renal insufficiency. In PD, acid-base
balance is maintained by including a buffer (that is, lactate)
in the dialysis solution in concentrations greater than those
in blood. Custommade PD solutions that were employed
during the evolution ofPD contained bicarbonate, because
bicarbonate is the major physiological buffer system in
body fluids (38-40). Current commercial PD solutions,
however, contain lactate, owing to the manufacturing
complexities involved in preparing a stable heatsterilized
solution containing bicarbonate, glucose, calcium, and
magnesium (40). With advances in sterilization methods
and delivery systems, bicarbonatecontaining solutions are
currently available for clinical use in some parts of the
Studies with bicarbonate-containing PD solutions have
used either bicarbonate alone (41-45) or a combination of
bicarbonate and lactate (41). In a long-term, randomized,
multicenter clinical study involving 123 adult patients (46),
the safety and efficacy of a 34 mmol/L bicarbonate-buffered
solution was compared to a solution containing 35 mmol/L
of lactate. At baseline, when patients were receiving 35
mmol/L lactate-buffered solution, 78.6% were acidotic.
There was no statistically significant change in the acid-
base status of the patients. When these patients were
switched to a solution containing 39 mmol/L bicarbonate,
mean bicarbonate levels increased from 22.9 ± 2.5
mmol/L to 28.7 ± 3.3 mmol/L (p < 0.05) after 4
weeks. The changes in bicarbonate were inversely
correlated with the metabolic acid production calculated
from the protein catabolic rate and apparent bicarbonate dis-
tribution space (43).
Based on both in vitra investigations and those in animal
models ( 47), a solution
concentrations of bicarbonate and CO2, and 15 mmol/L
lactate at physiologic pH has been described (41). A
parallel, randomized, open-label, prospective two month
clinical trial was performed to compare this new
combination solution to a solution containing 38 mmol/L of
bicarbonate alone (pH 7.3), and a control solution
containing 40 mmol/L lactate alone (pH 5.2) (41).
Approximately 20 patients were recruited in each group.
Results showed that both bicarbonate-containing solutions
maintained acidbase levels within the normal range and
that, in this respect, they were equivalent to the control 40
mmol/L lactate solution. There were no changes versus
baseline and no differences between groups in any of the
blood biochemistry parameters measured, or in transport
characteristics of the peritoneal
bicarbonate-based solutions were well tolerated.
Five of the patients enrolled in the study described above
(41) also participated in a study examining the
biocompatibility of the bicarbonate-buffered PD solutions
(48). In these studies, peritoneal macrophage function was
examined ex viva after exposure in viva to the 3 solutions.
The patients were dosed on 3 successive days with each of
the 3 solutions for 30-minute acute dwells. Tumor necrosis
factor-α (TNFα) release by isolated peritoneal
macrophages was assessed after ex viva exposure to
lipopolysaccharide. Results showed that exposure to either
of the bicarbonate-containing solutions resulted in a
significant increase in the generation of TNFα
compared with exposure to the lactate-only solution. These
results thus showed that peritoneal macrophage function
was enhanced after in viva exposure to bicarbonate-buffered
and bicarbonate/lactate-buffered solutions, and the authors
suggest that these solutions, and particularly the
bicarbonate/lactate combination solution, may improve the
local host defense status in PD patients.
These bicarbonate-buffered PD solutions have also been
examined for their impact on infusion pain in a randomized,
double-blind, cross-over study performed in 18 adult CAPD
patients experiencing infusion pain with conventional
lactate ( 40 mmol/L) PD solution (49). Both bicarbonate
alone (38 mmol/L) and bicarbonate/lactate (25 mmol/L and
15 mmol/L respectively) solutions resulted in highly
statistically significant reductions in infusion pain compared
to the control lactate solution, as assessed with a verbal
rating scale and a validated McGi11 pain questionnaire. The
bicarbonate/lactate solution was more effective than the
bicarbonate solution for all pain variables that were
The use ofbicarbonate-based solutions in children has so
far been limited to custom-made solutions for specific
indications, such as lactate intolerance (20),
by on July 13, 2011
or lactate acidosis (50). In addition to these indications, the
use ofpH-neutral, bicarbonate-based solutions might be of
special importance in pediatric patients prescribed very short
dwell times, such as for APD and in infants, where the
administration of standard solutions means frequent
exposure of the peritoneal membrane to acid solution. In a
recent single-dwell study, a 34 mmol/L bicarbonate solution
was found to be safe, well tolerated, and not to affect solute
transperitoneal equilibrium rates (51). The long-term
benefits in the general pediatric population have, however,
not yet been studied.
SUMMARY AND CONCLUSIONS
The standard PD solutions used today contain
physiological electrolyte profiles similar to that of interstitial
fluids and are supplemented with glucose as the osmotic
agent. Improvements in solution composition during the last
20 years have been largely restricted to minor changes in
buffer and electrolyte levels. Newer PD solutions, on the
other hand, are designed to manage comorbidities associated
with patients on maintenance dialysis, to tailor the ultra-
filtration profile based upon dwell time, and to better
preserve peritoneal membrane function and host defenses.
The evidence to date indicates that, in malnourished PD
patients (children and adults), IP amino acids improve
protein nutritional status, particularly if low protein intakes
are a cause of the malnutrition. The availability of glucose
polymers allows the clinician to complement standard
glucose-based formulations with one that can provide
improved ultrafiltration in both CAPD and APD patients for
long dwells, and in patients experiencing ultrafiltration loss
owing to a large effective peritoneal surface area. Owing to
the reduced calorie and carbohydrate load, glucose polymers
may also offer long-term metabolic advantages. Although
the control of acid-base balance can be well managed in the
vast majority of patients with a 35 40 mmol/L lactate
solution, the development and clinical evaluation of
bicarbonate-based solutions is underway as a result of
concern over the potentially bioincompatible nature of
acidic lactate formulations. To date, in vitra, ex viva, and
limited clinical studies show that such formulations, and in
particular bicarbonate/lactate combinations are efficacious
and well tolerated, and show improved peritoneal cell
function versus conventional solutions.
In conclusion, ongoing research and development has
produced a new generation ofPD solutions that, to various
degrees, meet different criteria established for an ideal PD
solution for chronic adult (52) and pediatric (53) patients on
PD. These criteria include good clearance and ultrafiltration,
supply of nutrition,
iso-osmolality, physiologic pH, bicarbonate buffer, and minimal
absorption of the osmotic agent. Several of the new solutions have
already demonstrated clinical utility in controlled clinical trials and
are commercially available in Europe. Wider clinical use will
further add to our understanding of the impact of these
formulations on patient outcomes.
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