Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT07193069
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062787', 'term': 'Drug Overdose'}, {'id': 'D000140', 'term': 'Acidosis, Lactic'}, {'id': 'D016883', 'term': 'Diabetic Ketoacidosis'}], 'ancestors': [{'id': 'D063487', 'term': 'Prescription Drug Misuse'}, {'id': 'D000076064', 'term': 'Drug Misuse'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007662', 'term': 'Ketosis'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-04-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2025-09-24', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of clinical and biological differences between patients admitted to intensive care for metformin overdose alone versus those with combined metformin and dapagliflozin overdose.', 'timeFrame': '10 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug Overdose', 'Metformin', 'Dapagliflozin', 'Lactic Acidosis', 'Diabetic Ketoacidosis', 'Intensive Care Units']}, 'descriptionModule': {'briefSummary': 'This study looks at patients admitted to intensive care for drug poisoning involving metformin, a common diabetes medication. Researchers will compare two groups: patients who overdosed on metformin alone and those who took both metformin and dapagliflozin, another diabetes drug. The goal is to find clinical or laboratory signs that could help doctors quickly recognize a dapagliflozin overdose in this context, which could improve treatment and patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of adult patients (aged 18 years and older) who were admitted to intensive care units across multiple centers for acute drug poisoning involving metformin, with or without dapagliflozin. Participants will be identified retrospectively through case collection from the SRLF (Société de Réanimation de Langue Française) and existing hospital records over the past 10 years. The study will include both cases of isolated metformin overdose and cases of combined metformin and dapagliflozin overdose.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Admission to an intensive care unit (ICU) due to acute drug poisoning\n* Documented exposure to either:\n* Metformin alone\n* Metformin in combination with dapagliflozin\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* No exposure to metformin\n* Exposure to dapagliflozin without metformin'}, 'identificationModule': {'nctId': 'NCT07193069', 'briefTitle': 'Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Saint-Denis'}, 'officialTitle': 'Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning', 'orgStudyIdInfo': {'id': '0109_REANIMATION_INTEND'}}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Denis', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nolan HASSOLD', 'role': 'CONTACT', 'email': 'coordination.rechercheclinique@ghtpdfr.fr', 'phone': '0142356140'}], 'facility': 'Centre Hospitalier de Saint-Denis', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Saint-Denis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}