Clinical trial NCT06838507: Incidence, Characterisation and Outcome-relevance of Perioperative SGLT2 Inhibitor Associated Ketoacidosis
Official title: Incidence, Characterisation and Outcome-relevance of Perioperative SGLT2 Inhibitor Associated Ketoacidosis - A Multicentre Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: SGLT2 Inhibitor
Ketoacidosis, Eugylcemic
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We aim to recruit patients at 20 German tertiary care centres. Coordinating centre will be the University Hospital Duesseldorf in Duesseldorf.

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with postoperative ketoacidosis
timeFrame: From the immediate postoperative period to the first postoperative morning
Secondary outcomes:
measure: Composite of postoperative complications
timeFrame: From enrollment to the end of follow up at 30 days after discharge
measure: Single postoperative complication
timeFrame: From enrollment to the end of follow up at 30 days after discharge
measure: Acute kidney injury
timeFrame: From enrollment to the end of follow up at 30 days after discharge
measure: Length of stay in-hospital
timeFrame: From enrollment to discharge (in-hospital) at approximately four days after surgery
measure: Length of stay on intensive care unit
timeFrame: From entering the intensive care unit to discharge to the normal ward at approximately 2 days after surgery
measure: Length of stay in the recovery room
timeFrame: From entering the recovery room to discharge to the normal ward at approximately one hour after surgery
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Department of Anaesthesiology, University Hospital Duesseldorf
Study officials:
References:
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