Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 5:15 PM
Study NCT ID:
NCT07206160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dapagliflozin on Interleukin 10 in Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-09-25', 'studyFirstSubmitQcDate': '2025-09-25', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the anti-inflammatory effect of dapagliflzin', 'timeFrame': '7 days', 'description': 'Effect on inflammatory markers (IL-10).'}, {'measure': 'The anti-inflammatory effect of dapagliflozin in patients with sepsis', 'timeFrame': 'baseline', 'description': 'Effect of dapagliflozin in sepsis evaluated by: Effect on inflammatory markers (IL-10).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '15090974', 'type': 'BACKGROUND', 'citation': 'Dellinger RP, Carlet JM, Masur H, Gerlach H, Calandra T, Cohen J, Gea-Banacloche J, Keh D, Marshall JC, Parker MM, Ramsay G, Zimmerman JL, Vincent JL, Levy MM; Surviving Sepsis Campaign Management Guidelines Committee. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med. 2004 Mar;32(3):858-73. doi: 10.1097/01.ccm.0000117317.18092.e4.'}, {'pmid': '26903338', 'type': 'BACKGROUND', 'citation': 'Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.'}], 'seeAlsoLinks': [{'url': 'https://www.sccm.org/clinical-resources/guidelines/guidelines/surviving-sepsis-guidelines-2021', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the long-term effects of dapagliflozin as anti-inflammatory agents to improve organ dysfunction and decrease mortality on patients of both genders ageing 18 years or above with sepsis.\n\n1ry Outcome: The anti-inflammatory effect of dapagliflozin in patients with sepsis evaluated by: Effect on inflammatory markers (IL-10).\n\n2ry Outcomes:\n\n1. Severity of sepsis evaluated by the SOFA score.\n2. Prognostic value of HDL compared to IL-10 for multi organ failure and death in septic patients and their correlation to the severity of sepsis.\n3. ICU mortality \\&hospital length stay.', 'detailedDescription': '64 Patients fulfilling the criteria for sepsis admitted to ICU will be allocated into 2 groups (32 patients in each group):\n\n* Dapagliflozin group: Patients will receive dapagliflozin at a dosage of 10mg mixed with 10ml water at the time of admission for 7 days (or until ICU discharge, whichever comes first).\n* Placebo group: Patients will receive vitastress tab .\n\nThe solutions of the study medications will be prepared by a hospital pharmacist and the medication will be administrated through the nasogastric tube in patients with disorder of consciousness or swallowing deficit.\n\nDapagliflozin will be stopped if the patients enter in more than one episode of severe hypoglycemia (≤50mg/dL) or occurrence of euglycemic diabetic ketoacidosis, defined by high anion gap metabolic acidosis and ketone bodies in the urine. Also the drug will be withheld if idiosyncratic drug reactions, such as DRESS syndrome (drug rash with eosinophilia and systemic symptoms) or allergic reaction to dapagliflozin has been occurred and if there is any need for absolute fasting and/or inability to access the enteral route for the drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '64 adult patients of both sex, over the age of 18 years who diagnosed with sepsis which meet the criteria: Suspicious/ known infection/ Increase of ≥ 2 SOFA score with elevated white blood cells and C reactive protein and inflammatory markers.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* 64 adult patients of both sex, over the age of 18 years who were admitted to the ICU with sepsis and those who developed sepsis in the ICU.\n\nExclusion Criteria:\n\n\\- 1. Patient's refusal, pregnant and lactating patients. 2. Known allergy or intolerance to dapagliflozin. 3. Unable to receive enteral medication\\& patients with chronic liver disease. 4. Shock 5. Patients with malabsorption disorders \\& or receipt of total parenteral nutrition and on treatment with statins.\n\n6\\. Patients with a history of familial hyperlipidemia. 7. End-stage renal disease (ESRD) on regular dialysis. 8. Type 1 diabetes."}, 'identificationModule': {'nctId': 'NCT07206160', 'briefTitle': 'Effect of Dapagliflozin on Interleukin 10 in Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Effect of Dapagliflozin on Interleukin 10 Compared to High Density Lipoprotein As a Prognosis in Septic Patients', 'orgStudyIdInfo': {'id': 'Dapagliflozin in sepsis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group (D) will receive dapagliflozin 10mg tablet and Group (C) will receive vitastress tablet'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mostafa Ragab Lokai, Assistant lecturer', 'role': 'CONTACT', 'email': 'ragab63mm@gmail.com', 'phone': '201021503446'}, {'name': 'Sara Mohammed Ali, Assistant professor', 'role': 'CONTACT', 'phone': '201005376176'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of Anesthesia and Intensive Care', 'investigatorFullName': 'Mostafa Ragab Lokai Shahat', 'investigatorAffiliation': 'Minia University'}}}}