NCT02698917: COMACARE

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

Completed NA Last updated 3 August 2018

What this trial tests

NA trial testing Low normal PaCO2 in Out-of-Hospital Cardiac Arrest in 123 participants. Completed in 3 May 2018.

Timeline

22 March 2016

Primary endpoint
3 November 2017

3 May 2018

Quick facts

Lead sponsor	Helsinki University Central Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	123
Start date	22 March 2016
Primary completion	3 November 2017
Estimated completion	3 May 2018
Sites	7 locations across Denmark, Finland

Drugs / interventions tested

• Low normal PaCO2
• High normal PaCO2
• Low normal PaO2
• High normal PaO2
• Low normal MAP
• High normal MAP

Conditions studied

• Out-of-Hospital Cardiac Arrest — all drugs for Out-of-Hospital Cardiac Arrest →

Sponsor

Helsinki University Central Hospital

Who can join

Adults 18 to 80, any sex, with Out-of-Hospital Cardiac Arrest. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting low-normal or high-normal mean arterial pressure after cardiac arrest and resuscitation: a randomised pilot trial.
   Jakkula P, Pettilä V, Skrifvars MB, Hästbacka J, et al · · 2018 · cited 159× · PMID 30443729 · DOI 10.1007/s00134-018-5446-8
2. Targeting two different levels of both arterial carbon dioxide and arterial oxygen after cardiac arrest and resuscitation: a randomised pilot trial.
   Jakkula P, Reinikainen M, Hästbacka J, Loisa P, et al · · 2018 · cited 136× · PMID 30430209 · DOI 10.1007/s00134-018-5453-9
3. Neurofilament light as an outcome predictor after cardiac arrest: a post hoc analysis of the COMACARE trial.
   Wihersaari L, Ashton NJ, Reinikainen M, Jakkula P, et al · · 2021 · cited 95× · PMID 32852582 · DOI 10.1007/s00134-020-06218-9
4. Optimum Blood Pressure in Patients With Shock After Acute Myocardial Infarction and Cardiac Arrest.
   Ameloot K, Jakkula P, Hästbacka J, Reinikainen M, et al · · 2020 · cited 70× · PMID 32792079 · DOI 10.1016/j.jacc.2020.06.043
5. Airway and ventilation management during cardiopulmonary resuscitation and after successful resuscitation.
   Newell C, Grier S, Soar J. · · 2018 · cited 56× · PMID 30111343 · DOI 10.1186/s13054-018-2121-y
6. Higher versus lower fraction of inspired oxygen or targets of arterial oxygenation for adults admitted to the intensive care unit.
   Barbateskovic M, Schjørring OL, Russo Krauss S, Jakobsen JC, et al · · 2019 · cited 42× · PMID 31773728 · DOI 10.1002/14651858.cd012631.pub2
7. Near-infrared spectroscopy after out-of-hospital cardiac arrest.
   Jakkula P, Hästbacka J, Reinikainen M, Pettilä V, et al · · 2019 · cited 31× · PMID 31088512 · DOI 10.1186/s13054-019-2428-3
8. Higher versus lower fractions of inspired oxygen or targets of arterial oxygenation for adults admitted to the intensive care unit.
   Klitgaard TL, Schjørring OL, Nielsen FM, Meyhoff CS, et al · · 2023 · cited 27× · PMID 37700687 · DOI 10.1002/14651858.cd012631.pub3