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

August 2, 2018 updated by: Pekka Jakkula, Helsinki University Central Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital
  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
      • Joensuu, Finland
        • North Karelia Central Hospital
      • Jyväskylä, Finland
        • Central Finland Central Hospital
      • Kuopio, Finland
        • Kuopio University Hospital
      • Lahti, Finland
        • Päijät-Häme Central Hospital
      • Tampere, Finland
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Low normal PaCO2, low normal PaO2, low normal MAP
Other: Low normal PaCO2
4.5-4.7 kPa
Other: Low normal PaO2
10-15 kPa
Other: Low normal MAP
65-75 mmHg
Active Comparator: Group 2
High normal PaCO2, low normal PaO2, low normal MAP
Other: Low normal PaO2
10-15 kPa
Other: Low normal MAP
65-75 mmHg
Other: High normal PaCO2
5.8-6.0 kPa
Active Comparator: Group 3
Low normal PaCO2, high normal PaO2, low normal MAP
Other: Low normal PaCO2
4.5-4.7 kPa
Other: Low normal MAP
65-75 mmHg
Other: High normal PaO2
20-25 kPa
Active Comparator: Group 4
High normal PaCO2, high normal PaO2, low normal MAP
Other: Low normal MAP
65-75 mmHg
Other: High normal PaCO2
5.8-6.0 kPa
Other: High normal PaO2
20-25 kPa
Active Comparator: Group 5
Low normal PaCO2, low normal PaO2, high normal MAP
Other: Low normal PaCO2
4.5-4.7 kPa
Other: Low normal PaO2
10-15 kPa
Other: High normal MAP
80-100 mmHg
Active Comparator: Group 6
High normal PaCO2, low normal PaO2, high normal MAP
Other: Low normal PaO2
10-15 kPa
Other: High normal PaCO2
5.8-6.0 kPa
Other: High normal MAP
80-100 mmHg
Active Comparator: Group 7
Low normal PaCO2, high normal PaO2, high normal MAP
Other: Low normal PaCO2
4.5-4.7 kPa
Other: High normal PaO2
20-25 kPa
Other: High normal MAP
80-100 mmHg
Active Comparator: Group 8
High normal PaCO2, high normal PaO2, high normal MAP
Other: High normal PaCO2
5.8-6.0 kPa
Other: High normal PaO2
20-25 kPa
Other: High normal MAP
80-100 mmHg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neuron-specific enolase (NSE) serum concentration
Time Frame: 48 hour after cardiac arrest
48 hour after cardiac arrest

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Between-group separation in PaCO2
Time Frame: Every 3 hour for 36 hour after admission to ICU
Every 3 hour for 36 hour after admission to ICU
Between-group separation in PaO2
Time Frame: Every 3 hour for 36 hour after admission to ICU
Every 3 hour for 36 hour after admission to ICU
Between-group separation in MAP
Time Frame: Every 1 hour for 36 hour after admission to ICU
Every 1 hour for 36 hour after admission to ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

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

Investigators

  • Study Director: Matti Reinikainen, Associate Professor, Kuopio University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2016

Primary Completion (Actual)

November 3, 2017

Study Completion (Actual)

May 3, 2018

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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