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NCT Number: NCT06838507

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

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

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Key information

Conditions

SGLT2 Inhibitor Acid-Base Imbalance Acidosis Ketoacidosis, Eugylcemic Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology, University Hospital Duesseldorf

Düsseldorf, 40225, Germany

Location contact

René M'Pembele, MD

PRINCIPAL_INVESTIGATOR

Sebastian Roth, MD

CONTACT

[email protected]

+4902118118451

Sebastian Roth, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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))

  3. 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

  4. Length of stay in-hospital

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

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

René M'Pembele, MD

CONTACT

[email protected]

+4902118118451

Sebastian Roth, MD

CONTACT

[email protected]

+4902118118451

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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