The use of helium after resuscitation: a safety and feasibility study
Phase 2
- Conditions
- Status na reanimatie ivm circulatiestilstandCardiac arrestResuscitation1001108210007963
- Registration Number
- NL-OMON32848
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
- Admission to the ICU after successful resuscitation after witnessed out-of-hospital cardiac arrest
- Post-anoxic 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
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 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint will be the occurrence of adverse events due to helium<br /><br>ventilation. This is defined as death or the necessity to stop ventilation<br /><br>using helium. The safety committee of this study will judge whether the adverse<br /><br>events occurred due to helium ventilation or had another cause.. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Neurological: biomarkers for cerebral damage (neuron specific enolase levels 24<br /><br>and 48 hours after admission), neurological outcome 30 after admission, as<br /><br>measured using the Glasgow outcome scale.<br /><br>Cardiological: biomarkers of myocardial damage ( troponine-T, CK, CK-MB )<br /><br>assessment cardiac injury by echocardiography ( in the first 72 hours after<br /><br>admission and at day 30).<br /><br>Pulmonary: Bloodgasanalysis, veneus saturation and settings of the ventilator<br /><br>during the first 6 hours. </p><br>