GLP-1 Analogs for Neuroprotection After Cardiac Arrest

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Experimental studies and previous clinical trials suggest neuroprotective effects of GLP-1 analogs in various degenerative neurological diseases, and in hypoxic brain injuries in experimental designs. 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jesper Kjaergaard
• Treatments: Exenatide; Glucagon-Like Peptide 1

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

• OHCA of presumed non-cardiac cause, e.g. after trauma or dissection/rupture of major artery OR Cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging).

• Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, clopidogrel) does not exclude the patient).

• Suspected or confirmed acute intracranial bleeding

• Suspected or confirmed acute stroke

• Unwitnessed asystole

• Known limitations in therapy and Do Not Resuscitate-order

• Known disease making 180 days survival unlikely

• Known pre-arrest cerebral performance category 3 or 4

• >4 hours (240 minutes) from ROSC to screening

• Systolic blood pressure <80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra aortic balloon pump/axial flow device*

• Temperature on admission <30°C.

• Known allergy to GLP-1 analogs, including Exenatide

• Known pancreatitis

• Diabetic ketoacidosis,

• Uncorrected blood glucose at admission < 2.5 mmol/l.

• If the systolic blood pressure (SBP) is recovering during the inclusion window (220 minutes) the patient can be included.