Table 1 Primary and secondary outcomes of the CCC trial
Feasibility outcomes | Screened:recruited patient ratio |
Weekly recruitment rate | |
Time from cardiac arrest to first analysis of arterial blood gas in intensive care unit | |
Separation in PaCO2 levels between groups for feasibility | |
Protocol adherence | |
Safety outcomes | Adverse changes in cerebral injury biomarkers (at 24 h, 48 h, and 72 h) |
Incidence and type of cardiac arrhythmias | |
Adverse changes in acid-base balance | |
Adverse changes in oxygenation (mean arterial carbon dioxide tension, fraction of inspired oxygen, alveolar-arterial gradient, positive end expiratory pressure requirement) | |
Adverse findings of cardiac echocardiography or cerebral computerized tomography | |
Occurrence of cerebral oedema or right ventricular failure and incidence of acute kidney injury as estimated using RIFLE (‘risk, injury, failure, loss, end-stage’ renal disease) criteria, need for renal replacement therapy or liver failure | |
Primary biological efficacy outcome | Difference in serum neuron-specific enolase and S100b protein concentrations at 24 h, 48 h, and 72 h compared with baseline for each group |
Secondary outcomes | Date, time and vital status at discharge from intensive care unit and hospital and discharge destination as clinical measures |
Glasgow Outcome Scale (Extended) assessed at 6 months from date of randomization for survivors, as a neurological assessment |