europrotective goal directed hemodynamic optimization in post-cardiac arrest patients: a randomized controlled trial (the NEUROPROTECT post-CA trial)

• Conditions: post-cardiac arrest patients; MedDRA version: 18.0Level: HLTClassification code 10047283Term: Ventricular arrhythmias and cardiac arrestSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-002151-10-BE
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-01
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Out-of-hospital CA of presumed cardiac cause irrespective of the presenting rhythm
-Unconsciousness (Glasgow coma scale < 8) at hospital admission
-Age = 18 years
-Sustained return of spontaneous circulation (ROSC) (=when chest compressions have not been required for 20 consecutive minutes)

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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

-Suspected or confirmed intracranial bleeding or stroke
-Known limitations in therapy or Do Not Resuscitate-order
-Known disease compromising 180 day survival
-Known pre-CA cerebral performance category 3-4
-Previous stroke (TIA can be included)
-MRI incompatible cardiac or neurosurgical device
-Systolic blood pressure < 90 mmHg on norepinephrine > 1 mcg/kg/min).
-Open chest
-ECMO (extracorporeal membrane oxygenation)
-Pregnancy

Study & Design

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