NCT02698917

Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation

Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation - Targeting High vs. Low Normal Values

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Out-of-Hospital Cardiac Arrest

Interventions

Type	Name	Description
OTHER	Low normal PaCO2	4.5-4.7 kPa
OTHER	High normal PaCO2	5.8-6.0 kPa
OTHER	Low normal PaO2	10-15 kPa
OTHER	High normal PaO2	20-25 kPa
OTHER	Low normal MAP	65-75 mmHg
OTHER	High normal MAP	80-100 mmHg

Timeline

• Start date: 2016-03-22
• Primary completion: 2017-11-03
• Completion: 2018-05-03
• First posted: 2016-03-04
• Last updated: 2018-08-03

Locations

7 sites across 2 countries: Denmark, Finland