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Clinical trial

The Effect of N-Acetylcysteine on Liver Functions After Mitral Valve Replacement: A Randomized Controlled Trial

ID
Name
MD-66-2017
Description
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, 34 candidates of on-pump MVR, aged 30 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 = 17 in each group).
Trial arms
Trial start
2024-06-30
Estimated PCD
2024-09-30
Trial end
2024-10-30
Status
Recruiting
Phase
Early phase I
Treatment
N acetyl cysteine
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
Arms:
NAC
Other names:
NAC
normal saline
the same volume of normal saline
Arms:
control
Other names:
placebo
Size
34
Primary endpoint
Malondialdahyde (MDA)
first postoperative day
Eligibility criteria
Inclusion Criteria: * Age from30 to 65 years * Both sexes * Patients undergoing on-pump elective MVR with cold cardioplegia. Exclusion Criteria: * • Patient refusal. * Allergy to any of the study medications. * Emergency procedures. * systolic dysfunction left ventricular ejection fraction \<40%. * Pre-existing hepatic dysfunction, as evident by elevated liver enzymes and bilirubin which is defined as an increase in liver enzymes AST and ALT \>10 times of baseline. * Patients on chronic use of drugs that might affect liver functions, e.g. NSAID, steroids, and anticonvulsants.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled study', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'quadrible blinded', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 34, 'type': 'ESTIMATED'}}
Updated at
2024-07-04

1 organization

1 product

2 indications

Organization
Kasr El Aini Hospital
Product
N acetyl cysteine
Indication
Oxidative Stress
Indication
Liver Dysfunction