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

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

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
Gastrointestinal	Other	Any other complication requiring additional surgery
Infection	Wound	Diagnosis made and confirmed by surgeon
	Severe sepsis	See International Sepsis Definitions Conference [30]

ISSN: 1745-6215