GLP-1 Analogs for Neuroprotection After Cardiac Arrest

What Was Tested

In this not phased trial, researchers set out to test Exenatide.

This study is designed as a safety and feasibility study with patients randomized 1:1 to receive GLP-1 analogs immediately after hospital admission after out of hospital cardiac arrest.

It had two arms (groups): GLP-1 (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

The brain of a patient resuscitated after cardiac arrest (CA) may have suffered ischemia and when the spontaneous circulation is re-established, the subsequent reperfusion may cause further damage.

Brain ischemia and the reperfusion injury lead to tissue degeneration and loss of neurological function, the extent dependent on duration and density of the insult.

This study is a double blinded randomized study seeking to evaluate the potential neuroprotective effects of GLP-1 analogs infused in comatose patients after out of hospital cardiac arrest.

Who Took Part

The registry lists 120 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Out of hospital cardiac arrest (OHCA) of presumed cardiac cause. Sustained return of spontaneous circulation (ROSC). Unconsciousness (GCS \<8 (Glasgow coma scale)) (patients not able to obey verbal commands). Sustained ROSC (Sustained ROSC: Sustained ROSC is when chest compressions have been not required for 20 consecutive minutes and signs of circulation persist).

The full record lists 4 inclusion and 19 exclusion criteria; among the exclusions: conscious patients (obeying verbal commands); females of childbearing potential (unless a negative pregnancy test can rule out pregnancy within the inclusion window); in-hospital cardiac arrest (ihca).

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2014-06 with completion listed for 2016-06.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 6 secondary outcomes, for example Neurological prognostication, Area under Neuron-specific Enolase curves (NSE), All cause mortality, Cerebral status and Area under S100b curve.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide in 120 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, all human trials.