Skip to main content
OpenTrials
Completed

NCT Number: NCT02432976

Impact of Perioperative Exenatide Infusion on Quality of Life in Cardiac Surgery Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Quality of Life

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 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.

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

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.

Other names: Byetta, Exendin-4, Incretin

Insulin

Drug

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 names: Humalog, Insulin Lispro, Human Analog

Primary outcomes

  1. Variation of the SF-36 score value at 3-months

    Time frame: 3 months

    The SF-36 score is a self-administered questionnaire that assess both the physical and the psychosocial health-related quality of life.

    The use of the SF-36 score is recommended by the French Health Authority in coronary patients.

    The variation of the SF-36 score value at 3-months is defined as the difference between the SF36-score value at 3 months minus the preoperative SF-36 score value.

Secondary outcomes

  1. Variation of the SF-36 score value at 1-month

    Time frame: 1 month

    The SF-36 score is a self-administered questionnaire that assess both the physical and the psychosocial health-related quality of life.

    The use of the SF-36 score is recommended by the French Health Authority in coronary patients.

    The variation of the SF-36 score value at 1-month is defined as the difference between the SF36-score value at 1 month minus the preoperative SF-36 score value.

  2. Variation of the SF-36 score value at 6-months

    Time frame: 6 months

    The SF-36 score is a self-administered questionnaire that assess both the physical and the psychosocial health-related quality of life.

    The use of the SF-36 score is recommended by the French Health Authority in coronary patients.

    The variation of the SF-36 score value at 6-months is defined as the difference between the SF36-score value at 6 months minus the preoperative SF-36 score value.

  3. Variation of the SF-36 score value at 12-months

    Time frame: 12 months

    The SF-36 score is a self-administered questionnaire that assess both the physical and the psychosocial health-related quality of life.

    The use of the SF-36 score is recommended by the French Health Authority in coronary patients.

    The variation of the SF-36 score value at 12-months is defined as the difference between the SF36-score value at 12 months minus the preoperative SF-36 score value.

  4. 1-month mortality

    Time frame: 1 month

  5. 3-months mortality

    Time frame: 3 months

  6. 6-months mortality

    Time frame: 6 month

  7. 12-months mortality

    Time frame: 12 months

  8. Postoperative left ventricular function

    Time frame: Day 7

    Left ventricular function will be assessed during a transthoracic echocardiography performed at Day 7.

    Left ventricular ejection fraction and filling pressure will be measured during this procedure.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • AstraZeneca
  • Eli Lilly and Company

Registry information

Official study title

Impact of Intravenous Exenatide Versus Insulin on Quality of Life in Cardiac Surgery Patients: an Ancillary Study of the ExSTRESS Phase II/III Clinical Trial

Acronym: ExeQOL

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 4, 2015
Registry last updated
Mar 9, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.