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

February 17, 2025 updated by: Heinrich-Heine University, Duesseldorf

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

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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with postoperative ketoacidosis
Time Frame: 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
From the immediate postoperative period to the first postoperative morning

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of postoperative complications
Time Frame: 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)
From enrollment to the end of follow up at 30 days after discharge
Single postoperative complication
Time Frame: 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))
From enrollment to the end of follow up at 30 days after discharge
Acute kidney injury
Time Frame: From enrollment to the end of follow up at 30 days after discharge
According to KDIGO definition and based on routinely measured creatinine
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
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
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
From entering the recovery room to discharge to the normal ward at approximately one hour after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-2935

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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