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SGLT2 InhibitorNCT06838507

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

An observational study of SGLT2 Inhibitor and Ketoacidosis, Eugylcemic, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SGLT2 Inhibitor, Ketoacidosis, Eugylcemic
How many people
2,000 participants
Where
1 siteGermany
Study dates
Apr 2025to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: We aim to recruit patients at 20 German tertiary care centres. Coordinating centre will be the University Hospital Duesseldorf in Duesseldorf.

Who may be able to join

  • 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

Who cannot join

  • Unwilling and/or unable to consent
  • Outpatient surgery

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sebastian Roth, MD contact

+4902118118451

Sebastian.Roth@med.uni-duesseldorf.de

René M'Pembele, MD contact

+4902118118451

Rene.MPembele@med.uni-duesseldorf.de

Germany1 site

  • Department of Anaesthesiology, University Hospital Duesseldorf

    Düsseldorf, 40225

    Sebastian Roth, MD, +4902118118451, Sebastian.Roth@med.uni-duesseldorf.de

    Sebastian.Roth@med.uni-duesseldorf.de

Other trials in Germany

About this study

Official title: 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
Medical subject headings
Ketosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From the immediate postoperative period to the first postoperative morning

Secondary outcomes (6)

  1. 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)

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

  2. 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))

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

  3. Acute kidney injury

    According to KDIGO definition and based on routinely measured creatinine

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

  4. Length of stay in-hospital

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

  5. Length of stay on intensive care unit

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2025
  2. Study startApr 2025 (estimated)
  3. Primary completionSep 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06838507
Sponsor's protocol ID
2024-2935
Status last verified
Jan 2025
First submitted
17 Jan 2025
Last updated
20 Feb 2025
Results posted
No
Data monitoring committee
No

Publications

  • Lurati Buse GA, Mauermann E, Ionescu D, Szczeklik W, De Hert S, Filipovic M, Beck-Schimmer B, Spadaro S, Matute P, Bolliger D, Turhan SC, van Waes J, Lagarto F, Theodoraki K, Gupta A, Gillmann HJ, Guzzetti L, Kotfis K, Wulf H, Larmann J, Corneci D, Chammartin-Basnet F, Howell SJ; MET: Reevaluation for Perioperative Cardiac Risk investigators; European Society of Anaesthesiology and Intensive Care. Risk assessment for major adverse cardiovascular events after noncardiac surgery using self-reported functional capacity: international prospective cohort study. Br J Anaesth. 2023 Jun;130(6):655-665. doi: 10.1016/j.bja.2023.02.030. Epub 2023 Apr 1.

    PubMed 37012173

  • Steinhorn B, Wiener-Kronish J. Dose-dependent relationship between SGLT2 inhibitor hold time and risk for postoperative anion gap acidosis: a single-centre retrospective analysis. Br J Anaesth. 2023 Oct;131(4):682-686. doi: 10.1016/j.bja.2023.06.063. Epub 2023 Aug 2.

    PubMed 37541949

  • Ruste M, Schweizer R, Groisne L, Fellahi JL, Jacquet-Lagreze M. Sodium-glucose cotransporter-2 inhibitors in non-diabetic patients: is there a perioperative risk of euglycaemic ketoacidosis. Br J Anaesth. 2024 Feb;132(2):435-436. doi: 10.1016/j.bja.2023.11.015. Epub 2023 Dec 4. No abstract available.

    PubMed 38052677

  • Oosterom-Eijmael MJP, Hermanides J, van Raalte DH, Hulst AH. Risk of perioperative discontinuation of SGLT2 inhibitors. Br J Anaesth. 2024 Aug;133(2):239-240. doi: 10.1016/j.bja.2024.05.004. Epub 2024 Jun 4.

    PubMed 38834489

  • Thiruvenkatarajan V, Meyer EJ, Nanjappa N, Van Wijk RM, Jesudason D. Perioperative diabetic ketoacidosis associated with sodium-glucose co-transporter-2 inhibitors: a systematic review. Br J Anaesth. 2019 Jul;123(1):27-36. doi: 10.1016/j.bja.2019.03.028. Epub 2019 May 3.

    PubMed 31060732

  • Colacci M, Fralick J, Odutayo A, Fralick M. Sodium-Glucose Cotransporter-2 Inhibitors and Risk of Diabetic Ketoacidosis Among Adults With Type 2 Diabetes: A Systematic Review and Meta-Analysis. Can J Diabetes. 2022 Feb;46(1):10-15.e2. doi: 10.1016/j.jcjd.2021.04.006. Epub 2021 Apr 28.

    PubMed 34116926

  • Long B, Lentz S, Koyfman A, Gottlieb M. Euglycemic diabetic ketoacidosis: Etiologies, evaluation, and management. Am J Emerg Med. 2021 Jun;44:157-160. doi: 10.1016/j.ajem.2021.02.015. Epub 2021 Feb 16.

    PubMed 33626481

  • Musso G, Saba F, Cassader M, Gambino R. Diabetic ketoacidosis with SGLT2 inhibitors. BMJ. 2020 Nov 12;371:m4147. doi: 10.1136/bmj.m4147. No abstract available.

    PubMed 33184044

  • McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Skibelund AK; ESC Scientific Document Group. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2023 Oct 1;44(37):3627-3639. doi: 10.1093/eurheartj/ehad195. No abstract available.

    PubMed 37622666

  • Nuffield Department of Population Health Renal Studies Group; SGLT2 inhibitor Meta-Analysis Cardio-Renal Trialists' Consortium. Impact of diabetes on the effects of sodium glucose co-transporter-2 inhibitors on kidney outcomes: collaborative meta-analysis of large placebo-controlled trials. Lancet. 2022 Nov 19;400(10365):1788-1801. doi: 10.1016/S0140-6736(22)02074-8. Epub 2022 Nov 6.

    PubMed 36351458

  • Solomon SD, McMurray JJV, Claggett B, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Jhund PS, Belohlavek J, Chiang CE, Borleffs CJW, Comin-Colet J, Dobreanu D, Drozdz J, Fang JC, Alcocer-Gamba MA, Al Habeeb W, Han Y, Cabrera Honorio JW, Janssens SP, Katova T, Kitakaze M, Merkely B, O'Meara E, Saraiva JFK, Tereshchenko SN, Thierer J, Vaduganathan M, Vardeny O, Verma S, Pham VN, Wilderang U, Zaozerska N, Bachus E, Lindholm D, Petersson M, Langkilde AM; DELIVER Trial Committees and Investigators. Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2022 Sep 22;387(12):1089-1098. doi: 10.1056/NEJMoa2206286. Epub 2022 Aug 27.

    PubMed 36027570

  • McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.

    PubMed 31535829

  • Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.

    PubMed 26378978

Questions about this trial

What is this clinical trial studying?

An observational study of SGLT2 Inhibitor and Ketoacidosis, Eugylcemic, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sebastian Roth, MD (+4902118118451, Sebastian.Roth@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with postoperative ketoacidosis (time frame: From the immediate postoperative period to the first postoperative morning). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06838507, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.

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