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

N/ANot Yet RecruitingNCT06838507

Heinrich-Heine University, Duesseldorf2,000 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

SGLT2 Inhibitor Ketoacidosis, Eugylcemic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

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

Time frame: From the immediate postoperative period to the first postoperative morning

Secondary Outcomes

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)

Time frame: From enrollment to the end of follow up at 30 days after discharge

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))

Time frame: From enrollment to the end of follow up at 30 days after discharge

Acute kidney injury

According to KDIGO definition and based on routinely measured creatinine

Time frame: From enrollment to the end of follow up at 30 days after discharge

Length of stay in-hospital

Time frame: From enrollment to discharge (in-hospital) at approximately four days after surgery

Length of stay on intensive care unit

Time frame: 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

Time frame: From entering the recovery room to discharge to the normal ward at approximately one hour after surgery

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts