Persistent coma after cardiac arrest. MedDRA version: 12.1 Level: LLT Classification code 10038749 Term: Resuscitation MedDRA version: 12.1 Level: LLT Classification code 10068191 Term: Postresuscitation encephalopathy MedDRA version: 12.1 Level: PT Classification code 10038749 Term: Resuscitation MedDRA version: 12.1 Level: PT Classification code 10068191 Term: Postresuscitation encephalopathy
Conditions
Sponsors
Academical Medical Center, University of Amsterdam
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: • No informed consent • Co-morbidity with a life expectancy of 50% and > 10 cm H2O PEEP at the time of inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: NSE level at 24 and 48 hours CK, CK-MB and trop-T the first 48 hours Echocardiography at <72 hours and at 30 days Ventilator settings and blood gas analyses the first 6 hours 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. | — |
Countries
Netherlands
Outcome results
None listed