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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.