Abstract

Background

Arterial carbon dioxide tension (PaCO2), oxygen tension (PaO2), and mean arterial pressure (MAP) are modifiable factors that affect cerebral blood flow (CBF), cerebral oxygen delivery, and potentially the course of brain injury after cardiac arrest. No evidence regarding optimal treatment targets exists.

Methods

The Carbon dioxide, Oxygen, and Mean arterial pressure After Cardiac Arrest and REsuscitation (COMACARE) trial is a pilot multi-center randomized controlled trial (RCT) assessing the feasibility of targeting low- or high-normal PaCO2, PaO2, and MAP in comatose, mechanically ventilated patients after out-of-hospital cardiac arrest (OHCA), as well as its effect on brain injury markers. Using a 23 factorial design, participants are randomized upon admission to an intensive care unit into one of eight groups with various combinations of PaCO2, PaO2, and MAP target levels for 36 h after admission.

The primary outcome is neuron-specific enolase (NSE) serum concentration at 48 h after cardiac arrest. The main feasibility outcome is the between-group differences in PaCO2, PaO2, and MAP during the 36 h after ICU admission. Secondary outcomes include serum concentrations of NSE, S100 protein, and cardiac troponin at 24, 48, and 72 h after cardiac arrest; cerebral oxygenation, measured with near-infrared spectroscopy (NIRS); potential differences in epileptic activity, monitored via continuous electroencephalogram (EEG); and neurological outcomes at six months after cardiac arrest.

Discussion

The trial began in March 2016 and participant recruitment has begun in all seven study sites as of March 2017. Currently, 115 of the total of 120 patients have been included. When completed, the results of this trial will provide preliminary clinical evidence regarding the feasibility of targeting low- or high-normal PaCO2, PaO2, and MAP values and its effect on developing brain injury, brain oxygenation, and epileptic seizures after cardiac arrest. The results of this trial will be used to evaluate whether a larger RCT on this subject is justified.

Trial registration

ClinicalTrials.gov, NCT02698917. Registered on 26 January 2016.

Details

Title
Targeting low- or high-normal Carbon dioxide, Oxygen, and Mean arterial pressure After Cardiac Arrest and REsuscitation: study protocol for a randomized pilot trial
Author
Jakkula, Pekka 1   VIAFID ORCID Logo  ; Reinikainen, Matti 2 ; Hästbacka, Johanna 1 ; Pettilä, Ville 1 ; Loisa, Pekka 3 ; Karlsson, Sari 4 ; Laru-Sompa, Raili 5 ; Bendel, Stepani 6 ; Oksanen, Tuomas 7 ; Birkelund, Thomas 8 ; Tiainen, Marjaana 1 ; Toppila, Jussi 1 ; Hakkarainen, Antti 1 ; Skrifvars, Markus B. 9 

1  University of Helsinki and Helsinki University Hospital, Helsinki, Finland (GRID:grid.7737.4) (ISNI:0000 0004 0410 2071) 
2  North Karelia Central Hospital, Joensuu, Finland (GRID:grid.416446.5) (ISNI:0000 0004 0368 0478) 
3  Päijät-Häme Central Hospital, Lahti, Finland (GRID:grid.440346.1) (ISNI:0000 0004 0628 2838) 
4  Tampere University Hospital, Tampere, Finland (GRID:grid.412330.7) (ISNI:0000 0004 0628 2985) 
5  Central Finland Central Hospital, Jyväskylä, Finland (GRID:grid.460356.2) (ISNI:0000 0004 0449 0385) 
6  Kuopio University Hospital, Kuopio, Finland (GRID:grid.410705.7) (ISNI:0000 0004 0628 207X) 
7  Jorvi Hospital, Espoo, Finland (GRID:grid.414747.5) (ISNI:0000 0004 0628 2344) 
8  Aarhus University Hospital, Aarhus, Denmark (GRID:grid.154185.c) (ISNI:0000 0004 0512 597X) 
9  University of Helsinki and Helsinki University Hospital, Helsinki, Finland (GRID:grid.7737.4) (ISNI:0000 0004 0410 2071); Monash University, Australia and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Melbourne, Australia (GRID:grid.1002.3) (ISNI:0000 0004 1936 7857) 
Pages
507
Publication year
2017
Publication date
Dec 2017
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-017-2257-0
ProQuest document ID
2795257202
Copyright
© The Author(s). 2017. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.