Table 1 Components of the composite primary outcome

Deep or organ/space surgical site infection

CDC criteria[49]

Sepsis

Positive blood culture and at least two of the following: Hypo or hyperthermia, tachycardia, tachypnea, leucopenia/leukocytosis ± DIC or multiorgan dysfunction

Bowel and surgical anastomosis stricture/obstruction or anastomotic leak

Requiring surgical intervention

Vascular graft thrombosis

Requiring surgical intervention

Bleeding

Requiring transfusion > 4 units of RBCs within the first 72 hours after surgery

Large peritoneal/pleural effusion

Diagnosed by X-Ray, ultrasound, and/or aspiration, and requiring chest tube, surgery, or ICU admission

Internal or external fistula formation

Requiring intervention

Stroke

New focal neurologic deficit of presumed vascular etiology persisted more than 24 hr with a neurologic study that did not indicate a different etiology

Pulmonary emboli (PE)

Sudden death or confirmation by V-Q scan showing high probability for PE, spiral CT scan or pulmonary arteriogram

Pulmonary edema and congestive heart failure

Shortness of breath, crepitation, peripheral edema and third heart sound and radiologic signs (cardiomegaly, interstitial edema, alveolar edema), medical treatment with diuretics

Myocardial infarction

ECG changes and/or elevated myocardial enzymes (cTn-T ≥0.2 ng/mL and/or CK ≥170IU and MB ≥5%)

Ventricular arrhythmias

ECG changes requiring medical treatment and/or electro-conversion

Renal failure

Requiring dialysis

Mortality

All-cause death within 30 postoperative days

Respiratory failure

Requiring intubation for more than 3 days

Pneumonia

New infiltrate on CXR combined with 2 of the following: temperature > 38°C, leukocytosis, and positive sputum or bronchial culture