Out-of-Hospital Cardiac Arrest Clinical Trial
Official title:
Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation - Targeting High vs. Low Normal Values
The COMACARE trial is a pilot multicenter randomized trial to assess the feasibility and
effect on brain injury markers of targeting low or high normal arterial oxygen tension
(PaO2), arterial carbon dioxide tension (PaCO2) and mean arterial pressure (MAP) in comatose,
mechanically ventilated patients after out-of-hospital cardiac arrest. Using factorial
design, participants are randomized at admission to intensive care unit to one of eight
groups targeting either low or high normal values of PaO2, PaCO2 and MAP for 36 h. In this
way, investigators will be assessing the feasibility and effect of all three variables at the
same time.
The primary outcome is serum concentration of neuron-specific enolase (NSE) at 48 h after
cardiac arrest. Feasibility outcome is between-group separation in PaO2, PaCO2 and MAP
levels. Secondary outcomes include continuous monitoring of cerebral oxygenation, EEG and ECG
for 48 h, the levels of NSE, S100B and cardiac troponin at randomization and 24, 48 and 72 h
after cardiac arrest and neurological assessment at 6 months after cardiac arrest.
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