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