Exenatide for Stress Hyperglycemia

Status

Completed

Phase

Phase 2/3

Enrollment

110 participants (actual)

Sponsor

Centre Hospitalier Universitaire de Besancon · Other

Design

Randomized · Open label (no masking)

Countries

1 country

France

Start

Jan 2015

Primary completion

Dec 2015

Completion

Dec 2016

First posted

25 Oct 2013 (estimated)

Last update posted

6 Oct 2017

Conditions

Stress Hyperglycemia

Stress hyperglycemia is a common phenomenon in cardiac surgery that concerns diabetic and non diabetic patients. It has been shown that perioperative hyperglycemia is an independent risk factor of postoperative mortality and morbidity. The Leuven et al.'s study suggested that strict glycemic perioperative control using an intensive insulin therapy could reduce mortality and morbidity in surgical intensive care's patients. This study included a majority of cardiac surgery patients. Others studies have suggested that the beneficial effect of insulin-based tight perioperative glycemic control might be hampered by iatrogenic hypoglycemia. Moreover, insulin therapy failed to obtain perioperative glycemic stability in most patients. Exenatide (Byetta ®) is an incretin mimetic, characterized by an anti-hyperglycemic effect that depends on the blood glucose level. We hypothesize that continuous intravenous infusion of exenatide could improve perioperative glycemic control and stability and could reduce the risk of iatrogenic hypoglycemia compared to a conventional insulin therapy during the perioperative period of cardiac surgery.

• Experimental

  Exenatide group

  Exenatide. Exenatide: bolus of 0.05 µg/min infused during the 1st hour of treatment, followed by a continuous infusion of 0.025 µg/min until the end of treatment. The exenatide therapy will begin as soon as a blood glucose level is above 140 mg/dl will be measured. A of exenatide will be intravenously . The treatment will be administrated during the first postoperative 48 hours in the intensive care unit or until intensive care unit discharge if this event occurs earlier.

• Active comparator

  Insulin group

  Insulin: Humalog (insulin lispro human analog). The insulin therapy will begin as soon as a blood glucose level is above 140 mg/dl will be measured. The dose of insulin intravenously infused will be adapted to blood glucose measurements, following the insulin therapy protocol used in our department. The insulin therapy protocol used in our department and prescribed as the benchmark treatment in the present study has been validated in a previous study. It has been derived from the protocol validated by Goldberg et al.

1. Percentage of patients spending more than 50 % of the time in the glycemic target range (100 to 140 mg/dl)

   Time frame · 48 hours

   Registry description

   The percentage of time spent achieving blood glucose control is defined as the ratio between the total time spent achieving blood glucose control and the total time under treatment. Blood glucose measurement will be done hourly. Blood glucose control is considered to be achieved between 2 blood glucose measurements if the first blood glucose value measured belongs to blood glucose target interval, defined as blood glucose level between 100 mg/dl l and 140 mg/dl l.