Table 1 Serious adverse events reported during the trial
From: Detailed statistical analysis plan for the pulmonary protection trial
Serious adverse events | Definition |
|---|---|
Pneumothorax or pleural effusion | Requiring drainage |
Major bleeding | More than 700 mL within the first 24 hours after surgery. |
Reoperation | Cardiac ischemia, server hemorrhage, cardiac tamponade, or pericardial effusion requiring reoperation. |
Severe infection | Sepsis, septic shock, and other serious infections. |
Cerebral event | Transient cerebral ischemic attack or stroke, myoclonic and/or tonic-clonic seizures. |
Hyperkaliemia | Hyperkaliemia (>5.5 mmol/L and treated with medicine). |
Acute myocardial infarction | ST- or non-ST-elevated myocardial infarction |
Cardiac arrhythmia | Atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation, and cardiac arrest mandating cardiopulmonary resuscitation. |
Renal replacement therapy | Continuous or intermittent |
Readmission with a respiratory-related problem | For example, pneumonia or acute exacerbation of chronic obstructive pulmonary disease. |