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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Exenatide

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type 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.

Interventions

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Exenatide

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.

Intervention Type DRUG

Insulin

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.

Intervention Type DRUG

Other Intervention Names

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Byetta Exendin-4 Incretin Humalog Insulin Lispro Human Analog

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No