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

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

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).

Study Overview

• Status: Completed
• Conditions: Oxidative Stress; Liver Dysfunction
• Intervention / Treatment: Other: normal saline; Drug: N acetyl cysteine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasralainy Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control; received the same volume of normal saline as placebo	Other: normal saline; the same volume of normal saline; Other Names: placebo
Active Comparator: 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	Drug: 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; Other Names: NAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malondialdahyde (MDA)	MDA is a marker of oxidative stress and one of the end-products of lipid peroxidation. MDA level reflects the degree of lipid peroxidation.	Postoperative day one

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MDA	MDA is a marker of oxidative stress and one of the end-products of lipid peroxidation. MDA level reflects the degree of lipid peroxidation.	preoperative and second postoperative day
liver function tests	ALT,AST,Bilirubin	preoperative ,first ,and,second post operative days
hemodunamics	MAP, HR	intraoperative
extubation time	time needed for extubation	postoperative 24 hr.
tissue perfusion	Lactate	preoperative ,first ,and,second post operative days

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2024
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 24, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: MDA; liver function; N-acetylcystien
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Amino Acids, Peptides, and Proteins; Sulfur Compounds; Organic Chemicals; Substandard Drugs; Pharmaceutical Preparations; Amino Acids; Crystalloid Solutions; Isotonic Solutions; Solutions; Cysteine; Amino Acids, Sulfur; Acetylcysteine; Counterfeit Drugs; Saline Solution
• Other Study ID Numbers: MD-66-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No