The use of Helium after Resuscitation: a safety and feasibility study - Heres

• Conditions: Persistent coma after cardiac arrest.; MedDRA version: 12.1Level: LLTClassification code 10038749Term: Resuscitation; MedDRA version: 12.1Level: LLTClassification code 10068191Term: Postresuscitation encephalopathy; MedDRA version: 12.1Level: PTClassification code 10038749Term: Resuscitation; MedDRA version: 12.1Level: PTClassification code 10068191Term: Postresuscitation encephalopathy

• Registration Number: EUCTR2009-017499-26-NL
• Lead Sponsor: Academical Medical Center, University of Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

•Admission to the ICU after successful CPR after witnessed out-of-hospital cardiac arrest
•Postanoxic coma on admission
•First registered rhythm ventricular fibrillation (VF) or ventricular tachycardia (VT)
•Return of spontaneous circulation within 30 minutes of arrest
•Ability to start study medication within 6 hours after arrest
•Treatment with induced mild hypothermia

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

Exclusion Criteria

•No informed consent
•Co-morbidity with a life expectancy of <6 months prior to cardiac arrest
•Pregnancy
•Neurological disorder prior to cardiac arrest
•Severely disabled prior to cardiac arrest
•A pulmonary condition requiring ventilation with a FiO2 >50% and > 10 cm H2O PEEP at the time of inclusion

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to investigate the feasibility and safety of helium ventilation post cardiac arrest. The main study endpoint will be the occurrence of major and minor adverse events: death and the necessity to stop ventilating using heliox. ;Secondary Objective: Secondary outcome parameters:<br>NSE level at 24 and 48 hours<br>CK, CK-MB and trop-T the first 48 hours<br>Echocardiography at <72 hours and at 30 days<br>Ventilator settings and blood gas analyses the first 6 hours<br>Glasgow Outcome Score at 30 days;Primary end point(s): The main endpoint will be the occurrence of adverse events due to helium ventilation. This is defined as death or the necessity to stop ventilation using helium, The safety committee of this study will judge whether the adverse events occurred due to helium ventilation or had another cause.