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Completed

NCT Number: NCT02698917

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

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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Key information

Conditions

Out-Of-Hospital Cardiac Arrest Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Arrest Heart Diseases Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low normal PaCO2

Other

4.5-4.7 kPa

High normal PaCO2

Other

5.8-6.0 kPa

Low normal PaO2

Other

10-15 kPa

High normal PaO2

Other

20-25 kPa

Low normal MAP

Other

65-75 mmHg

High normal MAP

Other

80-100 mmHg

Primary outcomes

  1. Neuron-specific enolase (NSE) serum concentration

    Time frame: 48 hour after cardiac arrest

Secondary outcomes

  1. Neuron-specific enolase (NSE) serum concentration

    Time frame: At randomization and 24 and 72 hour after cardiac arrest

  2. S100B protein serum concentration

    Time frame: At randomization and 24, 48 and 72 hour after cardiac arrest

  3. Cardiac troponin (TnT) serum concentration

    Time frame: At randomization and 24, 48 and 72 hour after cardiac arrest

  4. Cerebral oxygenation monitoring using near infrared spectroscopy (NIRS) monitoring

    Time frame: For 48 hour after admission to ICU

  5. Continuous electroencephalography (EEG) monitoring

    Time frame: For 48 hour after admission to ICU

  6. Functional status using cerebral performance category (CPC) classification

    Time frame: At 30 days and 6 months after cardiac arrest

Other outcomes

  1. Between-group separation in PaCO2

    Time frame: Every 3 hour for 36 hour after admission to ICU

  2. Between-group separation in PaO2

    Time frame: Every 3 hour for 36 hour after admission to ICU

  3. Between-group separation in MAP

    Time frame: Every 1 hour for 36 hour after admission to ICU

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Finnish Society of Anaesthesiologists
  • Laerdal Foundation
  • Orion Research Foundation
  • The Finnish Medical Association

Registry information

Official study title

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

Acronym: COMACARE

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 4, 2016
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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