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

Not Applicable

Completed

• Conditions: Out-of-Hospital Cardiac Arrest
• Interventions: Other: Low normal PaCO2; Other: High normal PaCO2; Other: High normal PaO2; Other: Low normal PaO2; Other: Low normal MAP; Other: High normal MAP

• Registration Number: NCT02698917
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-04
• Study Start: 2016-03-22
• Primary Completion: 2017-11-03
• Study Completion: 2018-05-03
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 4	Low normal MAP	High normal PaCO2, high normal PaO2, low normal MAP
Group 4	High normal PaO2	High normal PaCO2, high normal PaO2, low normal MAP
Group 8	High normal MAP	High normal PaCO2, high normal PaO2, high normal MAP
Group 5	Low normal PaCO2	Low normal PaCO2, low normal PaO2, high normal MAP
Group 2	Low normal MAP	High normal PaCO2, low normal PaO2, low normal MAP
Group 4	High normal PaCO2	High normal PaCO2, high normal PaO2, low normal MAP
Group 3	Low normal MAP	Low normal PaCO2, high normal PaO2, low normal MAP
Group 1	Low normal PaCO2	Low normal PaCO2, low normal PaO2, low normal MAP
Group 6	High normal PaCO2	High normal PaCO2, low normal PaO2, high normal MAP
Group 8	High normal PaCO2	High normal PaCO2, high normal PaO2, high normal MAP
Group 1	Low normal PaO2	Low normal PaCO2, low normal PaO2, low normal MAP
Group 3	Low normal PaCO2	Low normal PaCO2, high normal PaO2, low normal MAP
Group 6	High normal MAP	High normal PaCO2, low normal PaO2, high normal MAP
Group 7	High normal MAP	Low normal PaCO2, high normal PaO2, high normal MAP
Group 2	Low normal PaO2	High normal PaCO2, low normal PaO2, low normal MAP
Group 5	Low normal PaO2	Low normal PaCO2, low normal PaO2, high normal MAP
Group 5	High normal MAP	Low normal PaCO2, low normal PaO2, high normal MAP
Group 2	High normal PaCO2	High normal PaCO2, low normal PaO2, low normal MAP
Group 3	High normal PaO2	Low normal PaCO2, high normal PaO2, low normal MAP
Group 6	Low normal PaO2	High normal PaCO2, low normal PaO2, high normal MAP
Group 1	Low normal MAP	Low normal PaCO2, low normal PaO2, low normal MAP
Group 8	High normal PaO2	High normal PaCO2, high normal PaO2, high normal MAP
Group 7	Low normal PaCO2	Low normal PaCO2, high normal PaO2, high normal MAP
Group 7	High normal PaO2	Low normal PaCO2, high normal PaO2, high normal MAP

Primary Outcome Measures

Name	Time	Method
Neuron-specific enolase (NSE) serum concentration	48 hour after cardiac arrest

Secondary Outcome Measures

Name	Time	Method
Cardiac troponin (TnT) serum concentration	At randomization and 24, 48 and 72 hour after cardiac arrest
Continuous electroencephalography (EEG) monitoring	For 48 hour after admission to ICU
S100B protein serum concentration	At randomization and 24, 48 and 72 hour after cardiac arrest
Cerebral oxygenation monitoring using near infrared spectroscopy (NIRS) monitoring	For 48 hour after admission to ICU
Neuron-specific enolase (NSE) serum concentration	At randomization and 24 and 72 hour after cardiac arrest
Functional status using cerebral performance category (CPC) classification	At 30 days and 6 months after cardiac arrest

Trial Locations

Locations (7)

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

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark