GLP-1 analogues for neuroprotection after out-of-hospital cardiac arrest: study protocol for a randomized controlled trial
Key result
Exenatide is being evaluated for neuroprotective effects compared to placebo in an ongoing randomized controlled trial of 120 comatose patients resuscitated from out-of-hospital cardiac arrest.
Why the study?
Does exenatide infusion improve neuroprotection (measured by neuron-specific enolase) in unconscious patients resuscitated from out-of-hospital cardiac arrest?
Population
120 unconscious patients with sustained return of spontaneous circulation after out-of-hospital cardiac…
Comparison
Exenatide administered as a 6-hour and 15-minute… vs Placebo infusion
Design
One-to-one, blinded
Follow-up
180 days
Authors
Discussion
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Implication
This study protocol outlines a randomized trial to evaluate the neuroprotective effects of the GLP-1 analogue exenatide in comatose patients following out-of-hospital cardiac arrest.
Study Design
Type
RCT (n=120)
Blinding
Double-blind
Randomization
1:1 internet-based randomization algorithm
Multicenter
Yes
Structured PICO
Does exenatide infusion improve neuroprotection (measured by neuron-specific enolase) in unconscious patients resuscitated from out-of-hospital cardiac arrest?
P
Population
120 planned unconscious adult patients with sustained return of spontaneous circulation after out-of-hospital cardiac arrest, followed for 180 days.
I
Intervention
Exenatide administered as a 6-hour and 15-minute infusion, randomized 20 to 240 minutes after return of spontaneous circulation
C
Comparator
Placebo infusion
O
Outcome
Co-primary: feasibility (initiation of treatment within the inclusion window in >90% of participants) and efficacy (area under the neuron-specific enolase curve from 0 to 72 hours after admission)surrogate
This study protocol outlines a randomized trial to evaluate the neuroprotective effects of the GLP-1 analogue exenatide in comatose patients following out-of-hospital cardiac arrest.
Limitations
- The primary efficacy endpoint is a surrogate marker (area under the NSE-curve) rather than a hard clinical endpoint.
- The severely ill patient population with high mortality makes adjudication of adverse events challenging.
Cite This Study
Wiberg et al. (2016) conducted an RCT in Out-of-hospital cardiac arrest (n=120). Exenatide vs. Placebo was evaluated on Co-primary: Feasibility (initiation of treatment within 4 hours in >90% of participants) and efficacy (area under the neuron-specific enolase curve from 0 to 72 hours). Exenatide is being evaluated for neuroprotective effects compared to placebo in an ongoing randomized controlled trial of 120 comatose patients resuscitated from out-of-hospital cardiac arrest.