Incidence, Characterisation and Outcome-relevance of Perioperative SGLT2 Inhibitor Associated Ketoacidosis

Heinrich-Heine University, Duesseldorf

Status: Not yet enrolling

Conditions: SGLT2 Inhibitor; Ketoacidosis, Eugylcemic

Study type: Observational

Funder types: Other

Identifiers

NCT06838507

2024-2935

Details and patient eligibility

About

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

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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