The goal of this observational study is to generate data on the incidence and outcome-relevance of sodium-glucose cotransporter 2 (SGLT2) inhibitor associated ketoacidosis in adult patients with regular intake of any SGLT2 inhibitor within the last three months that are undergoing in-patient surgery. Further, it will describe strategies in current clinical practice to prevent and manage SGLT2 inhibitor associated ketoacidosis. The specific aims of this study are:
1. To assess the incidence of SGLT2 inhibitor associated ketoacidosis in surgical patients 2. To characterise fasting times in patients with SGLT2 inhibitor associated ketoacidosis 3. To describe the management of SGLT2 inhibitor associated ketoacidosis in current clinical practice 4. To assess the outcome impact of SGLT2 inhibitor associated ketoacidosis
Prescription and regular intakte of any SGLT2 inhibitor within the last three months (regardless if SGLT2 inhibitor was discontinued preoperatively or not)
Surgical procedure
At least one overnight stay in the hospital following surgery
Age >= 18 years
Unwilling and/or unable to consent
Outpatient surgery
We aim to recruit patients at 20 German tertiary care centres. Coordinating centre will be the University Hospital Duesseldorf in Duesseldorf.
Cohort
Prospective
Not listed
Number of patients with postoperative ketoacidosis
Ketoacidosis will be defined as by the American Diabetes Association: * pH \<= 7,30 * Serum bicarbonate \<= 18 mmol/l * Serum and/or urine ketones positive
Composite of postoperative complications
Composite of all-cause death, hospital readmission, major adverse cardiovascular events (defined as myocardial infarction, myocardial injury, cardiovascular death, non-fatal cardiac arrest, decompensated heart failure with the need for transfer to a higher unit of care, atrial fibrillation, pulmonary embolism, coronary revascularization), acute kidney injury according to KDIGO criteria or other major postoperative complications (defined as Clavien-Dindo class ≥ 3)
Single postoperative complication
Individual components of the composite (all-cause death, hospital readmission, major adverse cardiovascular events (defined as myocardial infarction, myocardial injury, cardiovascular death, non-fatal cardiac arrest, decompensated heart failure with the need for transfer to a higher unit of care, atrial fibrillation, pulmonary embolism, coronary revascularization), acute kidney injury according to KDIGO criteria or other major postoperative complications (defined as Clavien-Dindo class ≥ 3))
Acute kidney injury
According to KDIGO definition and based on routinely measured creatinine
Length of stay in-hospital
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
