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Completed

NCT Number: NCT01969149

Exenatide for 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.

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Key information

Conditions

Stress Hyperglycemia

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Post operative intensive care unit of the cardiac surgery department

Besançon, 25030, France

About this study

The phase II of the study will assess the safety and the efficacy of a continuous intravenous infusion of exenatide for the management of post operative stress hyperglycemia after planned coronary artery graft bypass (CABG) surgery.

A nested cohort study will concern the 24 first patients included in the study (12 patients/group) to assess the impact of a continuous intravenous infusion of exenatide on post operative glycemic variability after planned CABG surgery.

The aim of the phase III of the study will compare the efficacy of a continuous intravenous infusion of exenatide to the gold standard treatment, i.e the intravenous infusion of short-acting insulin, for the management of post operative stress hyperglycemia after planned CABG surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18.
  • Patient consent.
  • Non insulin requiring type 2 diabetic patients.
  • Non diabetic patients.
  • Planned coronary artery bypass graft (CABG) surgery.
  • ASA (American Society of Anesthesiologists) score 1, 2, or 3.

Exclusion criteria

  • Pregnancy and breast feeding.
  • Pancreatectomy.
  • Acute pancreatitis.
  • Chronic pancreatitis.
  • Type 1 diabetic patients.
  • Insulin requiring type 2 patients.
  • HbA1c>8%
  • Ketoacidosis.
  • Hyperosmolar coma.
  • Preoperative blood glucose level above 300 mg/dl [21].
  • Insulin or exenatide contraindication.
  • History of renal transplantation or currently receiving renal dialysis or creatinine clearance below 60 ml/min.
  • Emergency surgery.
  • Planned non CABG cardiac surgery.

Treatment and study plan

exenatide

Drug

Other names: Byetta, Exendin-4, Incretin

Insulin

Drug

Other names: Humalog Insulin Lispro Human Analog

Primary outcomes

  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

    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.

Secondary outcomes

  1. Hypoglycemia

    Time frame: 48 hours

    Hypoglycemia is defined as blood glucose level less than 80 mg/dl.

  2. Severe hypoglycemia

    Time frame: 48 hours

    Severe hypoglycemia is defined as blood glucose level less than 40 mg/dl.

  3. Number of patients needing rescue to insulin therapy protocol

    Time frame: 48 hours

  4. Number of adverse events occuring in the exenatide group

    Time frame: Day 30

    As the safety of exenatide has never been assessed in the perioperative period in cardiac surgery, all adverse events will be reported, in particular: known adverse events (diarrhea, nausea, vomiting) et severe adverse events (pancreatitis, acute renal failure, death, cardiac arrest).

  5. Mortality

    Time frame: Day 30

  6. Postoperative morbidity

    Time frame: Day 30

    Postoperative morbidity is defined as:

    • neurological complications: stroke.
    • renal complication: acute renal failure requiring dialysis.
    • cardiac complication: cardiogenic shock, arrhythmia, myocardial infarct.
    • vasopressive drug support in postoperative intensive care unit.
    • length of postoperative mechanical ventilation.
    • infectious complication: deep sternal infection.

  7. The mean (GluAve) and standard deviation (GluSD) of blood glucose

    Time frame: 48 hours

  8. The coefficient of variability (GluCV) of blood glucose level

    Time frame: 48 hours

    GluCV = GluSD*100/GluAve

  9. Mean number of blood glucose measured

    Time frame: 48 hours

  10. Mean difference between each blood glucose measurement and 120 mg/dl

    Time frame: 48 hours

  11. Perioperative cardiac mortality

    Time frame: Day 30

  12. Perioperative non cardiac mortality

    Time frame: Day 30

  13. Length of stay in intensive care unit

    Time frame: Day 30

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • AstraZeneca
  • Eli Lilly and Company

Registry information

Official study title

Intravenous Exenatide (Byetta®) Versus Insulin for Perioperative Glycemic Control in Cardiac Surgery: the Open-labeled Randomized Phase II/III ExStress Study

Acronym: ExSTRESS

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Oct 25, 2013
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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