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Table 2 Variables recorded in the CCC trial case report form

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

Baseline information Patient characteristics (age, sex, comorbities)
  Inclusion criteria and consent details
  Date and time of hospital admission
  Date and time of admission to intensive care unit
  APACHE II and III score on admission and immunocompromised status
  Date and time of randomization
Cardiac arrest characteristics Location (in or out of- hospital), date and time of cardiac arrest
  Bystander cardiopulmonary resuscitation
  Time (minutes) until emergency responder arrival
  Initial cardiac rhythm
  Time of first defibrillation and number of defibrillation episodes
  Time of return of spontaneous circulation
  Total adrenaline dose
  Suspected cause of cardiac arrest (arrhythmic, hypoxic, ischaemic, pulseless electrical activity)
Intensive care unit procedures and ventilation management Time of first arterial blood gas measurement and number of arterial blood gas measurements in first 24 h
  Therapeutic hypothermia initiated (yes or no)
  Nutrition commenced (yes or no)
  Coronary angiography in first 24 h
  Bicarbonate infusion commenced in first 24 h
  Recurrent cardiac arrhythmia (yes or no)
  Need for extracorporeal membrane oxygenation or renal replacement therapy
  Electroencephalography, computed tomography of the brain or echocardiography (yes and finding or not performed) in first 24 h
  Intravenous medication use (fentanyl, midazolam, neuromuscular blockage medication, midazolam, morphine, propofol)
  Duration of mechanical ventilation
  Arterial blood gas data during first 36 h of intensive care unit care while mechanically ventilated
  Ventilation data during first 36 h of intensive care unit care while mechanically ventilated
  Urinary and serum creatinine concentrations while in the intensive care unit
Clinical outcomes Date, time and vital status at discharge from intensive care unit
  Date, time and vital status at discharge from hospital
  Destination after discharge from hospital
Feasibility measures Screened:recruited patient ratio and weekly recruitment rate
  Separation in PaCO2 levels between groups
  Time (minutes) from cardiac arrest to first arterial blood gas analysis in intensive care unit
Safety measures Occurrence of severe raised intracranial pressure or right ventricular failure, incidence of acute kidney injury as estimated using RIFLE (‘risk, injury, failure, loss, end-stage’ renal disease) criteria and liver failure
Neurological evaluation measure Glasgow Outcome Scale (Extended) evaluation performed at 6 months
  1. APACHE, Acute Physiology and Chronic Health Evaluation; PaCO2, arterial carbon dioxide tension.