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

NCT06486805 | Completed Phase 4 DMC

• 1 other identifier: MD-66-2017
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Oxidative Stress; Liver Dysfunction

Keywords

MDA; liver function; N-acetylcystien

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• MDA

  preoperative and second postoperative day

• liver function tests

  preoperative ,first ,and,second post operative days

• hemodunamics

  intraoperative

• extubation time

  postoperative 24 hr.

• tissue perfusion

  preoperative ,first ,and,second post operative days

Study Arms (2)

control

PLACEBO COMPARATOR

received the same volume of normal saline as placebo

Other: normal saline

NAC

ACTIVE COMPARATOR

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

Interventions

N acetyl cysteine 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

Also known as: NAC

NAC

normal saline OTHER

the same volume of normal saline

Also known as: placebo

control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 70 years
• Both sexes
• Patients undergoing on-pump elective MVR with cold cardioplegia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasralainy Faculty of Medicine

Cairo, Egypt

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

Acetylcysteine; Saline Solution

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: quadrible blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstent professor

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 5, 2024
• Study Start: June 30, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 29, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)