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

What Was Tested

This registered phase 2, phase 3 trial tested Exenatide and Insulin (regular human).

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.

It had two arms (groups): Exenatide group (experimental) and Insulin group (active comparator).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 64 actual participants took part.

It was open to people of any sex aged from 18 years up to 99 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age over 18. 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.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: pregnancy and breast feeding; acute pancreatitis; chronic pancreatitis.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.

The Exenatide group and the comparison group ran side by side rather than switching.

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2015-05 with completion listed for 2017-01.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Variation of the SF-36 score value at 3-months (time frame: 3 months).

It also tracked 8 secondary outcomes, for example Variation of the SF-36 score value at 1-month, Variation of the SF-36 score value at 6-months, Variation of the SF-36 score value at 12-months, 1-month mortality, 3-months mortality and 6-months mortality.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Exenatide and Insulin (regular human) in 64 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page and the Insulin (regular human) compound page, all human trials.