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Table 1 Primary and secondary outcomes of the CCC trial

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