N-Acetyl Cysteine Effect on Liver Function After Mitral Valve Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2024-12-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Oxidative Stress Liver Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled study

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

quadrible blinded

Study Groups

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control

received the same volume of normal saline as placebo

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

the same volume of normal saline

NAC

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

Group Type ACTIVE_COMPARATOR

N acetyl cysteine

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

normal saline

the same volume of normal saline

Intervention Type OTHER

Other Intervention Names

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NAC placebo

Eligibility Criteria

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Inclusion Criteria

* Age from 18 to 70 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, which is defined as an increase in liver enzymes AST and ALT \>10 times the baseline.
* chronic use of drugs affecting liver functions, e.g., NSAIDs, steroids, and anticonvulsants.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No