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.
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
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.
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
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:
- To assess the incidence of SGLT2 inhibitor associated ketoacidosis in surgical patients
- To characterise fasting times in patients with SGLT2 inhibitor associated ketoacidosis
- To describe the management of SGLT2 inhibitor associated ketoacidosis in current clinical practice
- To assess the outcome impact of SGLT2 inhibitor associated ketoacidosis
- Conditions
- SGLT2 Inhibitor, Ketoacidosis, Eugylcemic
- Medical subject headings
- Ketosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
Length of stay in-hospital
Measured: From enrollment to discharge (in-hospital) at approximately four days after surgery
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
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.
- First posted20 Feb 2025
- Study startApr 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for SGLT2 InhibitorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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 37012173Steinhorn 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 37541949Ruste 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 38052677Oosterom-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 38834489Thiruvenkatarajan 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 31060732Colacci 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 34116926Long 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 33626481Musso 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 33184044McDonagh 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 37622666Nuffield 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 36351458Solomon 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 36027570McMurray 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 31535829Zinman 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