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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02698917
Acronym
COMACARE
Enrollment
123
Registered
2016-03-04
Start date
2016-03-22
Completion date
2018-05-03
Last updated
2018-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Out-of-Hospital Cardiac Arrest

Keywords

Out-of-Hospital Cardiac Arrest, Resuscitation, Hypoxia-Ischemia, Brain

Brief 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.

Interventions

OTHERLow normal PaCO2

4.5-4.7 kPa

OTHERHigh normal PaCO2

5.8-6.0 kPa

OTHERLow normal PaO2

10-15 kPa

20-25 kPa

65-75 mmHg

80-100 mmHg

Sponsors

Laerdal Foundation
CollaboratorOTHER
The Finnish Medical Association
CollaboratorOTHER
Orion Research Foundation
CollaboratorUNKNOWN
Finnish Society of Anaesthesiologists
CollaboratorUNKNOWN
Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The physician determining neurological outcome at six months after cardiac arrest is blinded to the study group allocations

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Witnessed out-of-hospital cardiac arrest with ventricular fibrillation (VF) or ventricular tachycardia (VT) as the initial rhythm * Delay of return of spontaneous circulation (ROSC) 10-45 min from the start of the arrest * Confirmed or suspected cardiac origin * Mechanical ventilation * Markedly impaired level of consciousness (no response to verbal commands and Glasgow coma scale \[GCS\] motor score \< 5) * Deferred consent possible or likely * Active intensive care initiated, including targeted temperature management (33-36 C)

Exclusion criteria

* Probable withdrawal of active ICU care due to terminal illness or poor prognosis because of severely reduced functional status before cardiac arrest * Confirmed or suspected intracranial pathology and/or suspicion of raised intracranial pressure * Pregnancy * Severe oxygenation problem (PaO2 / FiO2 \< 100 mmHg) * Severe COPD

Design outcomes

Primary

MeasureTime frame
Neuron-specific enolase (NSE) serum concentration48 hour after cardiac arrest

Secondary

MeasureTime frame
Cardiac troponin (TnT) serum concentrationAt randomization and 24, 48 and 72 hour after cardiac arrest
Cerebral oxygenation monitoring using near infrared spectroscopy (NIRS) monitoringFor 48 hour after admission to ICU
Continuous electroencephalography (EEG) monitoringFor 48 hour after admission to ICU
Functional status using cerebral performance category (CPC) classificationAt 30 days and 6 months after cardiac arrest
Neuron-specific enolase (NSE) serum concentrationAt randomization and 24 and 72 hour after cardiac arrest
S100B protein serum concentrationAt randomization and 24, 48 and 72 hour after cardiac arrest

Other

MeasureTime frame
Between-group separation in MAPEvery 1 hour for 36 hour after admission to ICU
Between-group separation in PaCO2Every 3 hour for 36 hour after admission to ICU
Between-group separation in PaO2Every 3 hour for 36 hour after admission to ICU

Countries

Denmark, Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026