Study protocol of a randomised controlled trial comparing perioperative intravenous insulin, GIK or GLP-1 treatment in diabetes–PILGRIM trial

Table 1 Composite endpoint major complications

Major complications	Definition
Death	30- day mortality of any cause
Re-admission	Unplanned admission within 30 days after discharge
ICU-admission	Unplanned ICU-admission within 30 days after discharge
Re-operation	Unplanned surgical intervention within 30 days after discharge
Deep wound infection	CDC definition [23]
Pneumonia	CDC definition [23]
Sepsis/bacteremia	CDC definition [23]
Myocardial infarction	ECG changes/elevated troponine T and/or CK-MB enzymes
Cerebrovascular event	Diagnosed by CT-scan
Deep venous thrombosis	Diagnosed by Doppler and treatment started
Lung embolus	Diagnosed by spiral CT-scan
Stent thrombosis	Requiring surgical intervention
Bleeding	Requiring intervention or transfusion of RBC’s
Respiratory failure	Requiring intubation/ventilator assistance >24 hours
Renal failure	Requiring dialysis

ICU = intensive care unit, CDC = centre for disease control, CXR = chest X-ray, ECG = electrocardiogram, RBC = red blood cells.

ISSN: 1471-2253