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

H

Helsinki University Central Hospital (HUCH)

Status

Completed

Conditions

Out-of-Hospital Cardiac Arrest

Treatments

Other: High normal PaO2
Other: Low normal MAP
Other: High normal PaCO2
Other: Low normal PaO2
Other: Low normal PaCO2
Other: High normal MAP

Study type

Interventional

Funder types

Other

Identifiers

NCT02698917
15/2015

Details and patient eligibility

About

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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Enrollment

123 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

123 participants in 8 patient groups

Group 1
Active Comparator group
Description:
Low normal PaCO2, low normal PaO2, low normal MAP
Treatment:
Other: Low normal PaCO2
Other: Low normal MAP
Other: Low normal PaO2
Group 2
Active Comparator group
Description:
High normal PaCO2, low normal PaO2, low normal MAP
Treatment:
Other: Low normal MAP
Other: Low normal PaO2
Other: High normal PaCO2
Group 3
Active Comparator group
Description:
Low normal PaCO2, high normal PaO2, low normal MAP
Treatment:
Other: Low normal PaCO2
Other: Low normal MAP
Other: High normal PaO2
Group 4
Active Comparator group
Description:
High normal PaCO2, high normal PaO2, low normal MAP
Treatment:
Other: Low normal MAP
Other: High normal PaCO2
Other: High normal PaO2
Group 5
Active Comparator group
Description:
Low normal PaCO2, low normal PaO2, high normal MAP
Treatment:
Other: Low normal PaCO2
Other: Low normal PaO2
Other: High normal MAP
Group 6
Active Comparator group
Description:
High normal PaCO2, low normal PaO2, high normal MAP
Treatment:
Other: Low normal PaO2
Other: High normal PaCO2
Other: High normal MAP
Group 7
Active Comparator group
Description:
Low normal PaCO2, high normal PaO2, high normal MAP
Treatment:
Other: Low normal PaCO2
Other: High normal PaO2
Other: High normal MAP
Group 8
Active Comparator group
Description:
High normal PaCO2, high normal PaO2, high normal MAP
Treatment:
Other: High normal PaCO2
Other: High normal PaO2
Other: High normal MAP

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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