Administration of a GLP-1 administration to reduce Brain injury follwing out of hospital cardiac arrest

Phase 1

• Conditions: We investigate the efficacy of commercially available GLP-1 analog for reducing post anoxic brain injury in patients who remain comatose after having been resuscitation from out of hospital cardiac arrest. The study is a double blid placebo controlled trial.; MedDRA version: 17.0Level: PTClassification code 10007515Term: Cardiac arrestSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-004311-45-DK
• Lead Sponsor: Copenhagen University Hospital Rigshospitalet, Department of Cardiology B 2143

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-21
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Age =18 years, out-of-hospital cardiac arrest of presumed cardiac cause, unconsciousness (Glasgow Coma Score <8) after sustained return of spontaneous circulation (ROSC) (20 minutes of circulation), Target temperature management is indicated
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Conscious patients, pregnancy, out-of-hospital cardiac arrest of presumed non-cardiac cause, cardiac arrest after arrival in hospital, known bleeding diathesis, suspected or confirmed acute intracranial bleeding, suspected or confirmed acute stroke, temperature on admission <30 C, unwitnessed asystole, persistent cardiogenic shock, known limitations in therapy, known disease making 180 day survival unlikely, known pre-arrest cerebral performance category 3 or 4, >240 minutes from ROSC to randomisation, known allergies to GLP-1 analogs, know pancreatitis, diabetic ketoacidosis, intial blood glucose < 2.5 mmol/l.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified