proMoting Effective Renoprotection in Cardiac sURgery patients by Inhibition of SGLT-2

简要总结

主要结局

次要结局

• Stage 3 AKI according to KDIGO criteria
• Postoperative maximum change of eGFR compared to the baseline eGFR
• De novo postoperative atrial fibrillation, registered on a 12-lead ECG
• LoS-ICU: Length of Stay in the Intensive Care Unit, measured in days
• LoS-Hos: Length of Stay in Hospital, measured in days
• MAKE: Major Adverse Kidney Events. Composite endpoint of death, new dialysis, and worsened renal function
• MACE: Major Adverse Cardiovascular Events. Composite endpoint of cardiovascular death, nonfatal myocardial infarction (MI), nonfatal ischaemic cerebral vascular accident (iCVA) and hospitalization for heart failure
• Patient reported quality of recovery (QoR), according to the following three questionnaires: o DAH30: Days at Home in first 30 days o WHO-DAS 2.0: World Health Organisation Disability Assessment Schedule 2.0 o EQ5D5L: 5 level EuroQol 5D questionnaire: a standardised measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal
• Safety outcomes: genital mycotic infections, diabetic keto-acidosis, and hypoglycaemia, in addition to incidence of postoperative complications and Serious Adverse Events (SAEs)
• Healthcare costs and productivity costs will be objectified to weigh cost-effectiveness, using the following two questionnaires: o iPCQ: IMTA (Institute for Medical Technology Assessment) Productivity Cost Questionnaire. o IMCQ: IMTA (Institute for Medical Technology Assessment) Medical Consumption Questionnaire.
• Peri-operative glucose measurements (routinely measured in clinical setting): average daily glucose, incidence of hypoglycaemia (blood glucose < 4 mmol/l) and hyperglycaemia (blood glucose > 10 mmol/l)
• Peri-operative heamodynamic vital signs (routinely measured in clinical setting).
• Postoperative of cardiac function (echocardiography and cardiac biomarkers) routinely carried out in clinical practice
• Urine oxygenation measured with an oxygen sensor placed in the urinary catheter: mean intraoperative urine oxygenation, change from baseline and mean postoperative urine oxygenation. Frequency and duration of monitor interruptions. Correlation in time between deprived urine oxygenation and current AKI markers.