The use of exenatide in severely burned pediatric patients

Abstract

Introduction: Intensive insulin treatment (IIT) has been shown to improve outcomes post-burn in severely burnt patients. However, it increases the incidence of hypoglycemia and is associated with risks and complications. We hypothesized that exenatide would decrease plasma glucose levels post-burn to levels similar to those achieved with IIT, and reduce the amount of exogenous insulin administered.

Methods: This open-label study included 24 severely burned pediatric patients. Six were randomized to receive exenatide, and 18 received IIT during acute hospitalization (block randomization). Exenatide and insulin were administered to maintain glucose levels between 80 and 140 mg/dl. We determined 6 AM, daily average, maximum and minimum glucose levels. Variability was determined using mean amplitude of glucose excursions (MAGE) and percentage of coefficient of variability. The amount of administered insulin was compared in both groups.

Results: Glucose values and variability were similar in both groups: Daily average was 130 ± 28 mg/dl in the intervention group and 138 ± 25 mg/dl in the control group (P = 0.31), MAGE 41 ± 6 vs. 45 ± 12 (respectively). However, administered insulin was significantly lower in the exenatide group than in the IIT group: 22 ± 14 IU patients/day in the intervention group and 76 ± 11 IU patients/day in the control group (P = 0.01). The incidence rate of hypoglycemia was similar in both groups (0.38 events/patient-month).

Conclusions: Patients receiving exenatide received significantly lower amounts of exogenous insulin to control plasma glucose levels. Exenatide was well tolerated and potentially represents a novel agent to attenuate hyperglycemia in the critical care setting.

Trial registration: NCT00673309.

Figure 1

CONSORT diagram. Eligibility and enrollment of patients.

Figure 2

Glucose values. Longitudinal analysis of the different glucose values along the 30 days of study. If less than three glucose values were obtained, maximum and minimum values were not calculated (see text for details). (a) Daily average. (b) Maximum. (c) Minimum. (d) Six AM glucose levels. IIT: Intensive insulin treatment. All values are represented as mean ± SEM.

Figure 3

Exogenous insulin administered and insulin plasma levels. (a) Insulin administered per patient per day. (b) Average of administered insulin per patient per acute hospital stay. (c) Mean plasma insulin levels. All values account for first 30 days of hospital stay. Values are represented as mean ± SEM.

Figure 4

MAGE. Mean amplitude of glucose excursion. Expressed as mean ± SEM.

Figure 5

Percentage of coefficient of variance (% CV).

Figure 6

Resting energy expenditure (REE). REE expressed as percentage of predicted. All values are represented as mean ± SEM.

Figure 7

Calories administered. Total amount of calories administered (per Kg) to the patients during the acute stay (first 30 days from admission). Data expressed as mean ± SEM.