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Table 2 Adverse events. Adverse events and definitions, reported from day 1 to discharge from the primary hospital

From: Time-differentiated target temperature management after out-of-hospital cardiac arrest: a multicentre, randomised, parallel-group, assessor-blinded clinical trial (the TTH48 trial): study protocol for a randomised controlled trial

Adverse events Definitions  
Cerebral Pupils Reacting to light, dilated (size), dilation difference between eyes
  Seizure Involuntary contractions or series of contractions of the voluntary muscles
  Myoclonus Short lasting involuntary contractions of one or several muscles
  Myoclonus state Continuous myoclonus
  Convulsive state Continuous seizures or continuous seizure pattern on EEG
Circulation Hypotension Mild: MAP >60 mmHg with one inotropic agent and volume infusion
   Moderate: MAP >60 mmHg with full treatment
   Severe: MAP 50–60 mmHg despite full treatment
   Circulatory failure: MAP <50 mmHg for more than 10 min despite full treatment
  Need for pacing  
Arrhythmias Mild Arrhythmias that do not demand treatment
  Moderate Stable haemodynamics (MAP >60 mmHg) with treatment
  Severe Pulseless VT/VF or unstable haemodynamics despite treatment
Gastrointestinal Mild Aspiration, can partly take enteral nutrition
  Moderate Aspiration more than 400 ml, cannot take any enteral nutrition
  Severe Ileus, bleeding gastric ulcer, need for explorative laparotomy or others
Urological Continuous or intermittent replacement therapy
Infectious/inflammatory Pneumonia New or progressing infiltrations on thoracic X-ray
   Fever (not during hypothermia treatment)
   Purulent tracheobronchial secretion
  SIRSa At least 2 of 4 SIRS criteria present
  Sepsis Sepsis, SIRS caused by an infection
  Severe sepsis Sepsis associated with organ dysfunction
  Septic shock Sepsis with hypotensionb
Bleeding and transfusion Bleeding Mild: no transfusion needed
   Moderate: up to two RBC units/24 hours.
   Severe: more than two RBC units/24 hours
   Critical bleeding in organs: intracranial, intrathecal, intraocular or pericardial
   Other bleeding: retroperitoneal, thorax or solid organs
  Transfusion Number of transfusions
  1. EEG electroencephalogram, MAP mean arterial pressure, VF ventricular fibrillation, VT ventricular tachycardia
  2. aSIRS: temperature >38 °C or <36 °C, pulse rate >90 beats/min, respiratory rate >20 breath/min or PaCO2 < 4.3 kPa or need for mechanical ventilation, leucocytes >12,000 cells/mm3, or <4000 cells/mm3, or >10 % immature cells
  3. RBC: red blood cell
  4. bsystolic blood pressure <90 mmHg or a reduction >40 mmHg from baseline and perfusions abnormalities or need for vasoactive drugs despite adequate volume treatment in the absence of other reasons for hypotension