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Active, Not Recruiting

NCT Number: NCT07127406

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

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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli City Hospital

Kocaeli, İzmit, 41060, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The incidence of diabetic ketoacidosis in Postoperative care unit among patients who receives SGLT-2 inhibitor

    Time frame: 24 hours after surgery

    Patients receiving SGLT-2 inhibitors will be follow up in postoperative care unit.

Secondary outcomes

  1. Length of ICU stay

    Time frame: 30 day

    Length of ICU stay will be recorded.

  2. Length of hospital stay

    Time frame: 30 days

    Length of hospital stay will be recorded

  3. ICU readmission

    Time frame: 30 days

    ICU readmission will be recorded

  4. 30 day mortality

    Time frame: 30 days

    Mortality will be recorded

Sponsors and collaborators

Lead sponsor

Kocaeli City Hospital

Other Gov

Registry information

Official study title

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

Acronym: SGLT-2I

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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