Postoperative Euglycemic Ketoacidosis Frequency in Sodium-Glucose Cotransporter-2 Inhibitor Users
SGLT-2I
The Frequency of Euglycemic Diabetic Ketoacidosis in Patients Using Sodium- Glucose Cotransporter-2 (SGLT-2) Inhibitor Admitted to the Postoperative Care Unit and Its Effect on Postoperative Outcomes: A Prospective Observational Study
1 other identifier
observational
300
1 country
1
Brief Summary
The goal of this observational study is to determine the frequency of postoperative euglycemic diabetic ketoacidosis (EDKA) in patients receiving Sodium- Glucose Cotransporter-2 (SGLT-2) inhibitors. The main questions it aims to answer are:Is the use of SGLT-2 inhibitors a factor that increases the incidence of euglycemic diabetic ketoacidosis in patients in the perioperative period or what conditions in the perioperative period cause EDKA in patients on SGLT-2 inhibitors?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2025
CompletedFirst Submitted
Initial submission to the registry
August 10, 2025
CompletedFirst Posted
Study publicly available on registry
August 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
September 17, 2025
September 1, 2025
2.1 years
August 10, 2025
September 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of diabetic ketoacidosis in Postoperative care unit among patients who receives SGLT-2 inhibitor
Patients receiving SGLT-2 inhibitors will be follow up in postoperative care unit.
24 hours after surgery
Secondary Outcomes (4)
Length of ICU stay
30 day
Length of hospital stay
30 days
ICU readmission
30 days
30 day mortality
30 days
Study Arms (2)
Euglycemic Diabetic ketoacidosis
Patients who develops euglycemic diabetic ketoacidosis during postoperative follow up will be included this group
No euglycemic diabetic ketoacidosis
Patients who do not develop euglycemic diabetic ketoacidosis during postoperative follow up
Eligibility Criteria
All patients admitted to the postoperative intensive care unit will be evaluated for inclusion in the study. patients over the age of 18 years who use SGLT-2 inhibitors in the preoperative period will be included in the study. they will be followed up for the development of euglycemic diabetic ketoacidosis after informed consent is obtained from them or their families.
You may qualify if:
- patients who is 18 years old and older
- Patients using SGLT-2 inhibitors and admitted to the postoperative intensive care unit after surgery.
You may not qualify if:
- Patients who is younger than 18 years old
- Patients who undergoes emergency surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kocaeli City Hospital
Kocaeli, İzmit, 41060, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ayşe Z Turan Cıvraz, Assoc. Prof.
Kocaeli City Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Days
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc.Prof.
Study Record Dates
First Submitted
August 10, 2025
First Posted
August 17, 2025
Study Start
May 1, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
September 17, 2025
Record last verified: 2025-09