Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 7:11 PM
Study NCT ID:
NCT07127406
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-17
First Post:
2025-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Euglycemic Ketoacidosis Frequency in Sodium-Glucose Cotransporter-2 Inhibitor Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016883', 'term': 'Diabetic Ketoacidosis'}], 'ancestors': [{'id': 'D007662', 'term': 'Ketosis'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '3 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-08-10', 'studyFirstSubmitQcDate': '2025-08-10', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of diabetic ketoacidosis in Postoperative care unit among patients who receives SGLT-2 inhibitor', 'timeFrame': '24 hours after surgery', 'description': 'Patients receiving SGLT-2 inhibitors will be follow up in postoperative care unit.'}], 'secondaryOutcomes': [{'measure': 'Length of ICU stay', 'timeFrame': '30 day', 'description': 'Length of ICU stay will be recorded.'}, {'measure': 'Length of hospital stay', 'timeFrame': '30 days', 'description': 'Length of hospital stay will be recorded'}, {'measure': 'ICU readmission', 'timeFrame': '30 days', 'description': 'ICU readmission will be recorded'}, {'measure': '30 day mortality', 'timeFrame': '30 days', 'description': 'Mortality will be recorded'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['euglycemic diabetic ketoacidosis', 'SGLT-2 Inhibitors'], 'conditions': ['Diabetic Ketoacidosis', 'Postoperative Care']}, 'descriptionModule': {'briefSummary': '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?', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who is 18 years old and older\n* Patients using SGLT-2 inhibitors and admitted to the postoperative intensive care unit after surgery.\n\nExclusion Criteria:\n\n* Patients who is younger than 18 years old\n* Patients who undergoes emergency surgery'}, 'identificationModule': {'nctId': 'NCT07127406', 'acronym': 'SGLT-2I', 'briefTitle': 'Postoperative Euglycemic Ketoacidosis Frequency in Sodium-Glucose Cotransporter-2 Inhibitor Users', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kocaeli City Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'KSH-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Euglycemic Diabetic ketoacidosis', 'description': 'Patients who develops euglycemic diabetic ketoacidosis during postoperative follow up will be included this group'}, {'label': 'No euglycemic diabetic ketoacidosis', 'description': 'Patients who do not develop euglycemic diabetic ketoacidosis during postoperative follow up'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41060', 'city': 'Kocaeli', 'state': 'İzmit', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli City Hospital', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'Ayşe Z Turan Cıvraz, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kocaeli City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc.Prof.', 'investigatorFullName': 'Ayse Zeynep Turan Civraz', 'investigatorAffiliation': 'Kocaeli City Hospital'}}}}