Recorded secondary and exploratory outcomes
Outcome measures | Time frame | Definition |
Secondary outcomes | ||
Individual AKI stages | ≤ 7 days postoperative | Incidence of stage 1, 2 and 3 AKI according to KDIGO criteria |
Creatinine | ≤ 7 days postoperative | Postoperative maximum change of creatinine compared with baseline creatinine |
AF | ≤ 7 days postoperative | Postoperative AF recorded with an ECG or for which treatment is initiated |
LoS-ICU | ≤ 30 days postoperative | LoS-ICU, measured in days from transfer to ICU until discharge from ICU |
LoS-Hos | ≤ 30 days postoperative | LoS-Hos, measured in days from surgery until discharge from the hospital |
MAKE | ≤ 30 days postoperative | MAKE. Composite endpoint of death, new dialysis and worsened renal function |
MACE | ≤ 30 days postoperative | MACE. Composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal ischaemic cerebral vascular accident and hospitalisation for heart failure |
Safety outcomes | ≤ 30 days postoperative | Genital mycotic infections, diabetic ketoacidosis and hypoglycaemia |
Hypoglycaemia | ≤ 3 days postoperative | Incidence of hypoglycaemia (blood glucose <4 mmol/L) detected during routine perioperative glucose measurements |
Hyperglycaemia | ≤ 3 days postoperative | Incidence of hyperglycaemia (blood glucose >10 mmol/L) detected during routine perioperative glucose measurements |
Cardiac biomarker 1: troponin | From transfer to ICU until 48 hours postoperatively | Peak troponin concentration as routinely measured during clinical practice |
Cardiac biomarker 2: CK-MB | From transfer to ICU until 48 hours postoperatively | Peak CK-MB concentration as routinely measured during clinical practice |
Patient-reported quality of recovery 1 | Recorded at 30 days postoperatively | According to Days at Home in first 30 days |
Patient-reported quality of recovery 2 | Recorded at 30 days postoperatively | According to WHO Disability Assessment Schedule 2.0 |
Patient-reported quality of recovery 3 | Recorded at 30 days postoperatively | According to 5 level EuroQol 5-Dimensions questionnaire |
Exploratory outcomes | ||
Systemic haemodynamics 1 | From start of anaesthesia until discharge from the ICU, assessed up to 72 hours | Perioperative hourly average heart rate |
Systemic haemodynamics 2 | From start of anaesthesia until discharge from the ICU, assessed up to 72 hours | Perioperative hourly average mean arterial blood pressure |
Systemic haemodynamics 3 | From start of anaesthesia until discharge from the ICU, assessed up to 72 hours | Perioperative hourly average cardiac output (L/min) |
Urinary oxygenation | From start of anaesthesia until discharge from the ICU, assessed up to 72 hours | Perioperative hourly average mean oxygen tension measured in the bladder |
Postoperative LVF | ≤ 30 days postoperative | Qualitative assessment (categorised as normal or mildly, moderately or severely reduced function) of LVF as noted by the echocardiographer for routinely performed postoperative echocardiography performed during routine follow-up |
Healthcare costs | Recorded at 30 days postoperatively | Using the iMCQ: IMTA (Institute for Medical Technology Assessment) Medical Consumption Questionnaire |
Productivity costs | Recorded at 30 days postoperatively | Using the iPCQ: IMTA (Institute for Medical Technology Assessment) Productivity Cost Questionnaire |
AF, atrial fibrillation; AKI, acute kidney injury; CK-MB, Creatine kinase myocardial band; ICU, intensive care unit; KDIGO criteria, kidney disease improving global outcomes; LoS-Hos, length of stay in the hospital; LoS-ICU, length of stay in the intensive care unit; LVF, left ventricle function; MACE, major adverse cardiovascular events; MAKE, major adverse kidney events.