Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-27 @ 9:11 PM
Study NCT ID:
NCT05613361
Status:
UNKNOWN
Last Update Posted:
2023-10-31
First Post:
2022-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Curcumin Against Colistin-induced Nephrotoxicity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003091', 'term': 'Colistin'}, {'id': 'D003474', 'term': 'Curcumin'}], 'ancestors': [{'id': 'D011113', 'term': 'Polymyxins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D023181', 'term': 'Antimicrobial Cationic Peptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000089882', 'term': 'Antimicrobial Peptides'}, {'id': 'D052899', 'term': 'Pore Forming Cytotoxic Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 214}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-05', 'lastUpdatePostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of acute kidney injury', 'timeFrame': 'Baseline to hospital discharge, an average of 14 days.', 'description': 'colistin induced nephrotoxicity (CIN) is defined as increase of serum creatinine by 0.3 mg/dL 48 hours after colistin administration'}], 'secondaryOutcomes': [{'measure': 'The incidence of acute tubular necrosis (ATN)', 'timeFrame': 'Baseline to hospital discharge, an average of 14 days.', 'description': 'will be evaluated by fractional excreted sodium (FENa)'}, {'measure': 'The difference between the levels of urinary NGAL', 'timeFrame': 'Baseline to hospital discharge, an average of 14 days.'}, {'measure': 'Mortality rate', 'timeFrame': 'Baseline to 30 days post discharge'}, {'measure': 'Total length of ICU and hospital stays.', 'timeFrame': 'Baseline to hospital discharge, an average of 14 days.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury', 'Drug-Induced Nephropathy']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to investigate the possible nephroprotective effect of curcumin in critically ill patients receiving colistin.', 'detailedDescription': 'The study will investigate the possible nephroprotective effect of curcumin when added to patients infected by MDR Gram-negative bacteria and require intravenous colistin therapy, curcumin will be given concurrently with colistin and discontinued at the same time as Colistin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All critically ill adult patients (18-65 years old) who are infected by MDR Gram-negative bacteria and require intravenous colistin therapy\n\nExclusion Criteria:\n\n* Patients receiving intravenous colistin therapy for \\< 72 hours.\n* Patients receiving renal replacement therapy (RRT).\n* Patients with diseases that may contribute to renal impairment such as systemic lupus erythematosus, acute myocardial infarction, cancer, HIV infection, glucose-6-phosphate-dehydrogenase deficiency, or urinary tract stone.\n* Pregnancy or breastfeeding.\n* Known allergy to the study medications.\n* Patients with chronic kidney diseases (creatinine clearance \\< 60 mg/dL).\n* Elevated total liver enzymes (AST, and ALT) three times above the upper limit of normal.\n* Patients with acute decompensated heart failure signs and symptoms requiring intravenous loop diuretics and/or intravenous inotropes and/or ACE inhibitors.\n* Uncontrolled diabetes (Glycosylated hemoglobin (Hb A1C) \\>8%).\n* Hypotensive patients defined as decrease in blood pressure less than 90/60 mm Hg.\n* Recent use of vitamins with antioxidant properties such as beta carotene, vitamin E, vitamin C, selenium, or N-acetylcysteine or any other medications known to have nephroprotective activities.\n* Patients receiving other nephrotoxic drugs at enrollment (e.g., aminoglycosides, vancomycin, or amphotericin B) or administration of contrast medium within 7 days.'}, 'identificationModule': {'nctId': 'NCT05613361', 'briefTitle': 'The Effect of Curcumin Against Colistin-induced Nephrotoxicity', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'The Effect of Curcumin Against Colistin-induced Nephrotoxicity', 'orgStudyIdInfo': {'id': 'curcumin in nephrotoxicity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'patients in this group will receive loading dose of colistin intravenously of 9 MIU followed by maintenance doses of 4.5 MIU given every 12 hours.', 'interventionNames': ['Drug: Colistin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'patients in this group will receive loading dose of colistin intravenously of 9 MIU followed by maintenance doses of 4.5 MIU given every 12 hours and curcumin will be administered as orally or through nasogastric tube at a dose of 2 capsules every 6 hours (1 gm/6 hour)', 'interventionNames': ['Drug: Colistin', 'Drug: Curcumin']}], 'interventions': [{'name': 'Colistin', 'type': 'DRUG', 'description': 'added for infection with multi drug resistant bacteria', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Curcumin', 'type': 'DRUG', 'description': 'added for the possible nephroprotective effect', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1133', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Alaa M Hammad', 'role': 'CONTACT', 'email': 'alaa.hammad.ph@o6u.edu.eg', 'phone': '01000675555'}], 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Alaa M. Hammad', 'role': 'CONTACT', 'email': 'alaa.hammad.ph@o6u.edu.eg', 'phone': '01000675555'}], 'overallOfficials': [{'name': 'Nirmeen A. Sabry', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Clinical Pharmacy Faculty of Pharmacy Cairo University'}, {'name': 'Maggie M. Abbassi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Clinical Pharmacy Faculty of Pharmacy Cairo University'}, {'name': 'Rania El-Husseiny', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Critical Care Medicine, Faculty of Medicine Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alaa Mohammed Hammad', 'investigatorAffiliation': 'October 6 University'}}}}