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Table 2 Major complications within the first 30 days after surgery embedded in the composite primary endpoint

From: Influence of early goal-directed therapy using arterial waveform analysis on major complications after high-risk abdominal surgery: study protocol for a multicenter randomized controlled superiority trial

Category

Complication

Criteria

Mortality

30-day mortality

Mortality within the first 30 days after surgery

Cardiovascular

Cardiac arrest

Cardiac arrest, electromechanical dissociation, ventricular fibrillation, or ventricular tachycardia without output

Acute myocardial infarction

According to the criteria for acute myocardial infarction (see Universal Definition of Myocardial Infarction [27])

Acute pulmonary edema

Diagnosis confirmed by X-ray

Stroke

Focal brain injury that persists for >24 hours, combined with an increase in disability of at least one grade on the modified Rankin scale [28], confirmed by cerebral CT-scan

Respiratory

Prolonged mechanical ventilation

Postoperative mechanical ventilation for more than 24 hours (any cause), including non-invasive pressure support ventilation through a face-mask

Pulmonary embolism

Confirmed by CT-scan

Pneumonia

Confirmed by X-ray and treated with antibiotics

Respiratory failure

Any other respiratory complication requiring mechanical ventilation (including non-invasive pressure support ventilation)

Renal

Acute kidney injury

Stage 2 or 3 acute kidney injury, according to the Acute Kidney Injury Network [29]

Gastrointestinal

Anastomotic leak

Diagnose made and confirmed by surgeon

Other

Any other complication requiring additional surgery

Infection

Wound

Diagnosis made and confirmed by surgeon

 

Severe sepsis

See International Sepsis Definitions Conference [30]