Impact of Perioperative Exenatide Infusion on Quality of Life in Cardiac Surgery Patients
Condition: Quality of Life
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A diminution of quality of life is often reported by patients after coronary artery bypass
      graft (CABG) surgery. A part of this diminution could be explain by postoperative left
      ventricular (LV) dysfunction.

      Exenatide (Byetta®) is an incretin mimetic, characterized by an anti-hyperglycemic effect
      that depends on the blood glucose level. Recent data have suggested that exenatide could
      improve LV function by an inotropic effect in patients suffering from cardiogenic shock or
      from congestive heart failure. Moreover, patients suffering from congestive heart failure
      reported a better quality of life when they were treated with exenatide compared to placebo.

      The investigators hypothesize that perioperative exenatide infusion could improve
      postoperative quality of life in CABG surgery patients.
    

Detailed description: 
      The ExeQOL study is an ancillary study of the ExSTRESS trial (www.clinicaltrials.gov
      identifier: NCT01969149).

      The ExSTRESS trial is a phase II/III randomized-controlled trial that aim at assessing
      intravenous exenatide versus insulin for perioperative glycemic control in CABG surgery.

      The phase II of the ExStress trial 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.

      The aim of the phase III of the ExSTRESS trial is to 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.
    

Intervention name(s): Exenatide; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Byetta; Exendin-4; Incretin; Humalog; Insulin Lispro; Human Analog
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Exenatide; Insulin Lispro; Incretins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quality of Life; Cardiac Surgery; Coronary Artery Bypass Graft Surgery; Incretin mimetic; Exenatide