An observational study in SGLT2 Inhibitor and Ketoacidosis, Eugylcemic, sponsored by Heinrich-Heine University, Duesseldorf. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by Heinrich-Heine University, Duesseldorf · Observational
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:
195 studies on the registry are indexed under Ketosis; 41 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 100 across 33 observational studies indexed under Ketosis.
Browse Ketosis studies →Heinrich-Heine University, Duesseldorf is the lead sponsor of 180 studies on the registry; 54 are open to participants now.
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We aim to recruit patients at 20 German tertiary care centres. Coordinating centre will be the University Hospital Duesseldorf in Duesseldorf.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Time frame: From the immediate postoperative period to the first postoperative morning
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)
Time frame: 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))
Time frame: 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
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
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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