Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-28 @ 11:20 PM
Study NCT ID:
NCT04893733
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2021-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Administration of Vitamin B Complex Improves Renal Recovery in Patients With AKI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D011507', 'term': 'Proteinuria'}], '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'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014803', 'term': 'Vitamin B Complex'}], 'ancestors': [{'id': 'D014815', 'term': 'Vitamins'}, {'id': 'D018977', 'term': 'Micronutrients'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2021-05-16', 'studyFirstSubmitQcDate': '2021-05-16', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete renal recovery', 'timeFrame': 'Day 7', 'description': 'Serum creatinine (CrS) level returns to its baseline value or to a lower value.'}], 'secondaryOutcomes': [{'measure': 'Progression to Acute Kidney Disease (AKD)', 'timeFrame': '1 month', 'description': 'A eGFR \\< than 60 ml/m/1.73m2'}, {'measure': 'De novo chronic kidney disease (CKD)', 'timeFrame': '3 months', 'description': 'An eGFR \\< than 60 ml/m/1.73m2'}, {'measure': 'Progression of CKD', 'timeFrame': '3 months', 'description': 'Patients progresses from a lower KDIGO CKD stage to a higher CKD stage'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Kidney Injury', 'Vitamin B complex', 'Creatinine', 'Proteinuria'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Animal and human studies have shown that the administration of vitamin B3 (niacin) improves renal ischemia; helping to recover from acute kidney injury (AKI) more effectively; Therefore, its use in patients with AKI could improve short-term outcomes: accelerating the recovery of renal function, reducing the days of hospital stay and costs; as well as reducing the incidence of chronic kidney disease (CKD) or progression of CKD after an episode of AKI.\n\nOur main objective is to determine the usefulness of the administration of vitamin B complex as a treatment for established acute kidney injury and its effect on short and long-term outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age who meet modified KDIGO criteria for Acute Kidney Injury, based on serum creatinine or urinary volume criteria.\n\nExclusion Criteria:\n\n* Patient under 18 years of age\n* Patients with stage G5 chronic kidney disease\n* Patients with chronic kidney replacement therapy.\n* Pregnant women\n* Transplant patients'}, 'identificationModule': {'nctId': 'NCT04893733', 'acronym': 'VIBAKI', 'briefTitle': 'Intravenous Administration of Vitamin B Complex Improves Renal Recovery in Patients With AKI', 'organization': {'class': 'OTHER', 'fullName': 'Caja Nacional de Salud'}, 'officialTitle': 'The Use of Intravenous Vitamin B Complex Improves Renal Recovery in Patients With Acute Kidney Injury', 'orgStudyIdInfo': {'id': 'VBCNS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin B complex', 'description': 'Randomized patients with AKI to this arm will received during 5 consecutive days IV Vitamin B complex each 12 hours.', 'interventionNames': ['Drug: Vitamin B Complex', 'Other: STOP AKI protocol']}], 'interventions': [{'name': 'Vitamin B Complex', 'type': 'DRUG', 'otherNames': ['Complejo B Vimin'], 'description': 'Patients with established AKI will be randomized to received IV vitamin B complex each 1 hours for 5 consecutive days versus placebo.\n\nEvery patients will also received Institution standard of care for AKI', 'armGroupLabels': ['Vitamin B complex']}, {'name': 'STOP AKI protocol', 'type': 'OTHER', 'description': 'STOP AKI protocols includes:\n\nS: identify and treat sepsis. Standard measures should be followed to decrease the risk of infection. Close surveillance to identify early signs of infection with appropriate treatment T: avoid nephrotoxins. Avoidance of drugs harmful to the kidneys (e.g. NSAIDs, gentamicin) Care with intravenous iodinated contrast O: optimize blood pressure and optimize volume status. Avoid dehydration e.g. confused patient. Treat hypovolaemia promptly. Consider with-holding patient anti-hypertensives/diuretics until assessed after major surgery or if patient develops sepsis/hypovolemia P: Prevent harm. Identify the cause promptly and manage appropriately to prevent progression. Prevent complications by instituting prompt therapy. Identify drugs excreted through the kidneys and adjust drug doses promptly if AKI develops. Review fluid management plans to prevent inadequate or excessive intravenous fluid administration', 'armGroupLabels': ['Vitamin B complex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0', 'city': 'Cochabamba', 'state': 'Departamento de Cochabamba', 'country': 'Bolivia', 'facility': 'Hospital Obrero No 2 - C.N.S.', 'geoPoint': {'lat': -17.38195, 'lon': -66.15995}}], 'overallOfficials': [{'name': 'Rolando Claure-Del Granado, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Obrero No 2 - C.N.S.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Caja Nacional de Salud', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Society of Nephrology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Division of Nephrology', 'investigatorFullName': 'Rolando Claure-Del Granado, MD', 'investigatorAffiliation': 'Caja Nacional de Salud'}}}}