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

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ID Serval
serval:BIB_2E23E91CA498
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
A pilot feasibility, safety and biological efficacy multicentre trial of therapeutic hypercapnia after cardiac arrest: study protocol for a randomized controlled trial.
Périodique
Trials
Auteur(s)
Eastwood G.M., Schneider A.G., Suzuki S., Bailey M., Bellomo R.
Collaborateur(s)
CCC trial investigators
ISSN
1745-6215 (Electronic)
ISSN-L
1745-6215
Statut éditorial
Publié
Date de publication
2015
Peer-reviewed
Oui
Volume
16
Numéro
1
Pages
135
Langue
anglais
Notes
Publication types: Journal Article Publication Status: epublish
Résumé
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.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612000690853 .
Pubmed
Web of science
Open Access
Oui
Création de la notice
01/05/2015 17:46
Dernière modification de la notice
20/08/2019 14:12
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