Skip to main content

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]