Safe and Effective Use of a Glycemic Control Protocol for Neonates in a Cardiac ICU*
ABSTRACT OBJECTIVE:: To investigate the safety and efficacy of a hyperglycemia protocol in neonates with critical cardiac illness. Neonates are often regarded as high risk for hypoglycemia while receiving continuous insulin infusions and thus have been excluded from some clinical trials. DESIGN:: A retrospective review. SETTING:: A pediatric cardiac ICU in a tertiary academic center. INTERVENTIONS:: Neonates with critical cardiac illness who developed hyperglycemia were placed on an insulin-hyperglycemia protocol at the attending physician's discretion. Insulin infusions were titrated based on frequent blood glucose monitoring. MEASUREMENTS:: Critical illness hyperglycemia was defined as a blood glucose > 140 mg/dL. Hypoglycemia was defined as moderate (≤ 60 mg/dL) or severe (≤ 40 mg/dL). Initiating blood glucose, lowest blood glucose during insulin infusion, doses of insulin, duration of insulin, and time to blood glucose < 140 mg/dL were evaluated. MAIN RESULTS:: A total of 44 patients were placed on the protocol between January 2009 and October 2011. The majority of insulin infusions were initiated in the early postoperative period (33 of 44, 75%). Moderate hypoglycemia occurred in two patients (4.5%), with blood glucose levels of 49 and 53 mg/dL. No episodes of severe hypoglycemia occurred. A total of 345 discrete blood glucose levels were analyzed; two of these being < 60 mg/dL (0.58%). Mean blood glucose prior to starting insulin was 252 ± 45 mg/dL and time until euglycemia was 6.1 ± 3.9 hrs. The mean duration of insulin infusion was 24.6 ± 38.7 hrs, mean peak dose was 0.10 ± 0.05 units/kg/hr, and mean insulin dose was 0.06 ± 0.02 units/kg/hr. For postoperative patients, mean time after bypass until onset of hyperglycemia was 2.2 ± 2.6 hrs. CONCLUSIONS:: A glycemic control protocol can safely and effectively be applied to neonates with critical cardiac disease. Neonates with critical cardiac illness should be included in clinical trials evaluating the benefits of glycemic control.
- Pediatric Critical Care Medicine 03/2013; 14(3):328-9. DOI:10.1097/PCC.0b013e3182760675 · 2.33 Impact Factor
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ABSTRACT: Objective To investigate the effectivity of pentoxifylline (PTX) and immunoglobulin M (IgM)-enriched intravenous immunoglobulin (IVIG) therapy in the treatment of neonatal sepsis (NS), alone or in combination. Study design This was a prospective, double-blind, controlled study. Newborns with suspicion of sepsis were enrolled in the study. The patients were separated into four groups according to treatment protocol: Group 1 = placebo, Group 2 = pentoxifylline, Group 3 = IgM-enriched IVIG, and Group 4 = pentoxifylline + IgM-enriched IVIG. Blood samples were taken for C-reactive protein, interleukin-6, neutrophil CD64 expression, and tumor necrosis factor-alfa measurements immediately before treatment (1st day), and measurements were repeated on the 2nd and 4th days of the therapy. Results A total of 204 patients, 51 in each group, were recruited into the study. There were no significant differences for symptoms of sepsis among groups, except lethargy. No significant differences were observed among the groups according to laboratory data. Overall mortality rate was 8.8%. The rates of morbidities and mortality among study groups were similar. Conclusion PTX and IgM-enriched IVIG therapies, either alone or in combination, did not reduce the rates of morbidities and mortality in NS.American Journal of Perinatology 02/2014; 31(10). DOI:10.1055/s-0033-1363771 · 1.60 Impact Factor
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ABSTRACT: Our previous randomized clinical trial showed that post-operative tight glycemic control (TGC) for children undergoing cardiac surgery did not reduce the rate of healthcare-associated infections compared to standard care (STD). Heterogeneity of treatment effect may exist within this population. We performed a post-hoc exploratory analysis on 980 children from birth to 36 months at the time of cardiac surgery who were randomized to post-operative TGC or STD in the intensive care unit. Significant interactions were observed between treatment group and both neonate (age ≤30 days, P=0.03) and intraoperative glucocorticoid exposure (P=0.03) on the risk of infection. The rate and incidence of infections in subjects ≤60 days old were significantly increased in the TGC group compared to the STD group (rate 13.5 vs. 3.7 infections/1,000 CICU days, P=0.01; incidence 13% vs. 4%, P=0.02), while infections among those >60 days of age was significantly reduced in TGC compared to STD (rate 5.0 vs. 14.1 infections/1,000 CICU days, P=0.02; incidence 2% vs. 5%, P=0.03); the treatment group by age subgroup interaction was highly significant (P=0.001). Multivariable logistic regression controlling for the main effects revealed that previous cardiac surgery, chromosomal anomaly, and delayed sternal closure were independently associated with increased risk of infection. This exploratory analysis demonstrated that TGC may lower the risk of infection in children >60 days old at the time of cardiac surgery compared to children receiving STD. Meta-analyses of past and ongoing clinical trials are necessary to confirm these findings before altering clinical practice. www.clinicaltrials.gov. Identifier: NCT00443599.Circulation 03/2014; 129(22). DOI:10.1161/CIRCULATIONAHA.113.008124 · 14.95 Impact Factor