Postoperative Euglycemic Ketoacidosis Frequency in Sodium-Glucose Cotransporter-2 Inhibitor Users

NCT ID: NCT07127406

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-06-01

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?

Detailed Description

Diabetes Mellitus (DM) is one of the leading diseases with serious social and economic consequences and high mortality and morbidity. Diabetic ketoacidosis is a serious complication of DM. Diabetic ketoacidosis (DKΑ) is typically associated with type 1 diabetes. It also occurs in type 2 diabetes under conditions of extreme stress, such as severe infection, trauma, cardiovascular or other emergencies, in association with the use of SGLT2 inhibitors, or as a manifestation of type 2 diabetes in some populations, a disorder called ketosis-prone diabetes mellitus. Treatment of DKA is a clinical emergency. Hyperglycemia (blood glucose >250 mg/dL), metabolic acidosis (pH<7.3), ketosis (ketonemia or ketonuria) are the diagnostic criteria for diabetic ketoacidosis . Although elevated glucose is considered to be the sine qua non of diabetic ketoacidosis, diabetic ketoacidosis may be observed in a group of patients with blood glucose <250 mg/dL. This condition is called euglycemic diabetic ketoacidosis (EDKA). Although it is a rare condition, a normal glucose level may lead to delayed treatment and consequently increased morbidity and mortality, as it may distract from the diagnosis. The pathophysiology of this clinical condition is unclear and has been reported in patients with type 1 and type 2 diabetes with SGLT2 inhibitor use.Factors that increase the risk of EDKA in patients using SGLT2 inhibitors include vomiting, dehydration, infection, surgery, low-carbohydrate diet, and underlying malignancy, which are common conditions in surgical patients. In recent years, with the increase in the frequency of EDKA in the perioperative period, it is recommended by the US Food and Drug Administration to discontinue this group of drugs at least 3-4 days before surgery.

The use of SGLT2 inhibitors is rapidly increasing in patients diagnosed with diabetes, heart failure and chronic kidney disease due to their nephroprotective and cardioprotective effects. SGLT-2 inhibitor use is also more common in the surgical patient population. The number of patients operated in the operating rooms of our hospital in 2023 is 23502. The number of patients admitted to the postoperative care unit (PACU) since the opening of our hospital is 3135. The majority of these patients have hypertension, diabetes mellitus, chronic heart failure and other comorbidities.

Conditions

Diabetic Ketoacidosis; Postoperative Care

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Euglycemic Diabetic ketoacidosis

Patients who develops euglycemic diabetic ketoacidosis during postoperative follow up will be included this group

No interventions assigned to this group

No euglycemic diabetic ketoacidosis

Patients who do not develop euglycemic diabetic ketoacidosis during postoperative follow up

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• patients who is 18 years old and older
• Patients using SGLT-2 inhibitors and admitted to the postoperative intensive care unit after surgery.

Exclusion Criteria

• Patients who is younger than 18 years old
• Patients who undergoes emergency surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kocaeli City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ayse Zeynep Turan Civraz

Assoc.Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayşe Z Turan Cıvraz, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Kocaeli City Hospital

Locations

Kocaeli City Hospital

Kocaeli, İzmit, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KSH-01

Identifier Type: -

Identifier Source: org_study_id