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A pilot feasibility, safety and biological efficacy multicentre trial of therapeutic hypercapnia after cardiac arrest: study protocol for a randomized controlled trial

Eastwood, Glenn M., Schneider, Antoine G., Suzuki, Satoshi, Bailey, Michael and Bellomo, Rinaldo 2015, A pilot feasibility, safety and biological efficacy multicentre trial of therapeutic hypercapnia after cardiac arrest: study protocol for a randomized controlled trial, Trials, vol. 16, pp. 1-6, doi: 10.1186/s13063-015-0676-3.

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Title A pilot feasibility, safety and biological efficacy multicentre trial of therapeutic hypercapnia after cardiac arrest: study protocol for a randomized controlled trial
Author(s) Eastwood, Glenn M.
Schneider, Antoine G.
Suzuki, Satoshi
Bailey, Michael
Bellomo, Rinaldo
Journal name Trials
Volume number 16
Article ID 135
Start page 1
End page 6
Total pages 6
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2015
ISSN 1745-6215
Keyword(s) Adult
Cerebrovascular Circulation
Clinical Protocols
Feasibility Studies
Heart Arrest
Hospitalization
Humans
Hypercapnia
Intensive Care Units
Prospective Studies
Cardiac arrest
Normocapnia
Randomized trial
Resuscitation
CCC trial investigators
Summary BACKGROUND: Cardiac arrest causes ischaemic brain injury. Arterial carbon dioxide tension (PaCO2) is a major determinant of cerebral blood flow. Thus, mild hypercapnia in the 24 h following cardiac arrest may increase cerebral blood flow and attenuate such injury. We describe the Carbon Control and Cardiac Arrest (CCC) trial.

METHODS/DESIGN: The CCC trial is a pilot multicentre feasibility, safety and biological efficacy randomized controlled trial recruiting adult cardiac arrest patients admitted to the intensive care unit after return of spontaneous circulation. At admission, using concealed allocation, participants are randomized to 24 h of either normocapnia (PaCO2 35 to 45 mmHg) or mild hypercapnia (PaCO2 50 to 55 mmHg). Key feasibility outcomes are recruitment rate and protocol compliance rate. The primary biological efficacy and biological safety measures are the between-groups difference in serum neuron-specific enolase and S100b protein levels at 24 h, 48 h and 72 h. Secondary outcome measure include adverse events, in-hospital mortality, and neurological assessment at 6 months.

DISCUSSION: The trial commenced in December 2012 and, when completed, will provide clinical evidence as to whether targeting mild hypercapnia for 24 h following intensive care unit admission for cardiac arrest patients is feasible and safe and whether it results in decreased concentrations of neurological injury biomarkers compared with normocapnia. Trial results will also be used to determine whether a phase IIb study powered for survival at 90 days is feasible and justified.
Language eng
DOI 10.1186/s13063-015-0676-3
Field of Research 1102 Cardiovascular Medicine And Haematology
1103 Clinical Sciences
Socio Economic Objective 920103 Cardiovascular System and Diseases
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2015, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30080838

Document type: Journal Article
Collections: School of Nursing and Midwifery
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.