Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT06486805
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2024-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
N-Acetyl Cysteine Effect on Liver Function After Mitral Valve Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'quadrible blinded'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-24', 'studyFirstSubmitDate': '2024-06-21', 'studyFirstSubmitQcDate': '2024-06-27', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Malondialdahyde (MDA)', 'timeFrame': 'Postoperative day one', 'description': 'MDA is a marker of oxidative stress and one of the end-products of lipid peroxidation. MDA level reflects the degree of lipid peroxidation.'}], 'secondaryOutcomes': [{'measure': 'MDA', 'timeFrame': 'preoperative and second postoperative day', 'description': 'MDA is a marker of oxidative stress and one of the end-products of lipid peroxidation. MDA level reflects the degree of lipid peroxidation.'}, {'measure': 'liver function tests', 'timeFrame': 'preoperative ,first ,and,second post operative days', 'description': 'ALT,AST,Bilirubin'}, {'measure': 'hemodunamics', 'timeFrame': 'intraoperative', 'description': 'MAP, HR'}, {'measure': 'extubation time', 'timeFrame': 'postoperative 24 hr.', 'description': 'time needed for extubation'}, {'measure': 'tissue perfusion', 'timeFrame': 'preoperative ,first ,and,second post operative days', 'description': 'Lactate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MDA', 'liver function', 'N-acetylcystien'], 'conditions': ['Oxidative Stress', 'Liver Dysfunction']}, 'descriptionModule': {'briefSummary': 'This study aimed at the impact of the N-acetyl cysteine on the improvement of liver function subsequently on-pum mitral valve replacement. Following a clinical trial design, 54 candidates of on-pump MVR, aged 18 to 70 years, with normal liver and renal function were selected. The candidates were randomly divided into intervention: IV150 mg/ kg N-acetyl cysteine over 15 min, and control groups (normal saline as placebo) (n = 27 in each group).', 'detailedDescription': 'In a randomized controlled prospective study conducted in a teaching hospital, after approval by the ethics committee and informed consent, 54 candidates for on-pump MVR, aged 18 to 70 years, with normal liver and renal function, were selected. The candidates were randomly divided into intervention: IV 150 mg/ kg N-acetyl cysteine over 15 min then 50 mg/kg over 4 hrs for 3 days, and control groups (normal saline as placebo) (n = 27 in each group).and we will assess the effect of NAC on intra-operative hemodynamics and post-operative its protective rule against oxidative stress and liver dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 to 70 years\n* Both sexes\n* Patients undergoing on-pump elective MVR with cold cardioplegia.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Allergy to any of the study medications.\n* Emergency procedures.\n* systolic dysfunction, left ventricular ejection fraction \\<40%.\n* Pre-existing hepatic dysfunction, which is defined as an increase in liver enzymes AST and ALT \\>10 times the baseline.\n* chronic use of drugs affecting liver functions, e.g., NSAIDs, steroids, and anticonvulsants.'}, 'identificationModule': {'nctId': 'NCT06486805', 'acronym': 'NAC', 'briefTitle': 'N-Acetyl Cysteine Effect on Liver Function After Mitral Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'The Effect of N-Acetylcysteine on Liver Functions After Mitral Valve Replacement: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MD-66-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'received the same volume of normal saline as placebo', 'interventionNames': ['Other: normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NAC', 'description': 'received 150 mg/kg NAC in 200 ml of 5% glucose over 15 min through the central line after induction of anesthesia and intubation followed by 50 mg/kg of NAC in 500 ml of 5% glucose over 4 h', 'interventionNames': ['Drug: N acetyl cysteine']}], 'interventions': [{'name': 'N acetyl cysteine', 'type': 'DRUG', 'otherNames': ['NAC'], 'description': 'N-acetylcysteine (NAC) is a small molecule containing a thiol (sulfhydryl-containing) group, which has antioxidant properties and is freely filterable, thus making it readily accessible to the intracellular compartment', 'armGroupLabels': ['NAC']}, {'name': 'normal saline', 'type': 'OTHER', 'otherNames': ['placebo'], 'description': 'the same volume of normal saline', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasralainy Faculty of Medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstent professor', 'investigatorFullName': 'Ahmed Mohamed Mohamed Elhaddad', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}