Incidence, Characterisation and Outcome-relevance of Perioperative SGLT2 Inhibitor Associated Ketoacidosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: SGLT2 Inhibitor, Ketoacidosis, Eugylcemic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Incidence, Characterisation and Outcome-relevance of Perioperative SGLT2 Inhibitor Associated Ketoacidosis - A Multicentre Prospective Cohort Study
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
Primary outcome measures
- Number of patients with postoperative ketoacidosis [Time frame: From the immediate postoperative period to the first postoperative morning]
Secondary outcome measures (6)
- Composite of postoperative complications [Time frame: 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]
- Acute kidney injury [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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Anaesthesiology, University Hospital Duesseldorf — Düsseldorf
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 33184044
Identifiers
NCT: NCT06838507 · 2024-2935