Ketoacidosis, Eugylcemic, SGLT2 Inhibitor
Conditions
Brief summary
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
Interventions
None listed
Sponsors
Heinrich-Heine University, Duesseldorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Unwilling and/or unable to consent * Outpatient surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with postoperative ketoacidosis | From the immediate postoperative period to the first postoperative morning | Ketoacidosis will be defined as by the American Diabetes Association: * pH \<= 7,30 * Serum bicarbonate \<= 18 mmol/l * Serum and/or urine ketones positive |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single postoperative complication | From enrollment to the end of follow up at 30 days after discharge | 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 | From enrollment to the end of follow up at 30 days after discharge | According to KDIGO definition and based on routinely measured creatinine |
| Composite of postoperative complications | From enrollment to the end of follow up at 30 days after discharge | 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) |
| Length of stay on intensive care unit | From entering the intensive care unit to discharge to the normal ward at approximately 2 days after surgery | — |
| Length of stay in the recovery room | From entering the recovery room to discharge to the normal ward at approximately one hour after surgery | — |
| Length of stay in-hospital | From enrollment to discharge (in-hospital) at approximately four days after surgery | — |
Countries
Germany
Contacts
Primary ContactSebastian Roth, MD
Backup ContactRené M'Pembele, MD
Outcome results
None listed