Diabetic KetoacidosisSGLT-2INCT07127406
Postoperative Euglycemic Ketoacidosis Frequency in Sodium-Glucose Cotransporter-2 Inhibitor Users
An observational study of Diabetic Ketoacidosis and Postoperative Care, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Ketoacidosis, Postoperative Care
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Jun 2027
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- patients who is 18 years old and older
- Patients using SGLT-2 inhibitors and admitted to the postoperative intensive care unit after surgery.
Who cannot join
- Patients who is younger than 18 years old
- Patients who undergoes emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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?
Read the 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
- Keywords
- euglycemic diabetic ketoacidosis, SGLT-2 Inhibitors
- Medical subject headings
- Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after surgery
Secondary outcomes (4)
Length of ICU stay
Length of ICU stay will be recorded.
Measured: 30 day
Length of hospital stay
Length of hospital stay will be recorded
Measured: 30 days
ICU readmission
ICU readmission will be recorded
Measured: 30 days
30 day mortality
Mortality will be recorded
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 May 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Zeynep Turan Civraz, Kocaeli City Hospital
- Investigators
- Ayşe Z Turan Cıvraz, Assoc. Prof., Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127406
- Sponsor's protocol ID
- KSH-01
- Acronym
- SGLT-2I
- Status last verified
- Sep 2025
- First submitted
- 10 Aug 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07127406
- Acronym / sponsor ID
- SGLT-2I / KSH-01
- Conditions
- Diabetic Ketoacidosis, Postoperative Care
- Keywords
- euglycemic diabetic ketoacidosis, SGLT-2 Inhibitors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- patients who is 18 years old and older
- Patients using SGLT-2 inhibitors and admitted to the postoperative intensive care unit after surgery.
Key exclusion criteria (2 listed)
- Patients who is younger than 18 years old
- Patients who undergoes emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Length of ICU stay
Time frame: 30 day
Length of hospital stay
Time frame: 30 days
ICU readmission
Time frame: 30 days
30 day mortality
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşe Z Turan Cıvraz, Assoc. Prof. principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Ketoacidosis and Postoperative Care, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of diabetic ketoacidosis in Postoperative care unit among patients who receives SGLT-2 inhibitor (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.