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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
123
4.5-4.7 kPa
5.8-6.0 kPa
10-15 kPa
20-25 kPa
65-75 mmHg
80-100 mmHg
Aarhus University Hospital
Aarhus, Denmark
Helsinki University Hospital
Helsinki, Finland
North Karelia Central Hospital
Joensuu, Finland
Central Finland Central Hospital
Jyväskylä, Finland
Kuopio University Hospital
Kuopio, Finland
Päijät-Häme Central Hospital
Lahti, Finland
Tampere University Hospital
Tampere, Finland
Neuron-specific enolase (NSE) serum concentration
Time frame: 48 hour after cardiac arrest
Neuron-specific enolase (NSE) serum concentration
Time frame: At randomization and 24 and 72 hour after cardiac arrest
S100B protein serum concentration
Time frame: At randomization and 24, 48 and 72 hour after cardiac arrest
Cardiac troponin (TnT) serum concentration
Time frame: At randomization and 24, 48 and 72 hour after cardiac arrest
Cerebral oxygenation monitoring using near infrared spectroscopy (NIRS) monitoring
Time frame: For 48 hour after admission to ICU
Continuous electroencephalography (EEG) monitoring
Time frame: For 48 hour after admission to ICU
Functional status using cerebral performance category (CPC) classification
Time frame: At 30 days and 6 months after cardiac arrest
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