NCT06838507

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

Incidence, Characterisation and Outcome-relevance of Perioperative SGLT2 Inhibitor Associated Ketoacidosis - A Multicentre Prospective Cohort Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• SGLT2 Inhibitor
• Ketoacidosis, Eugylcemic

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2025-02-20
• Last updated: 2025-02-20

Locations

1 site across 1 country: Germany