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

Phase 4

Completed

• Conditions: Oxidative Stress; Liver Dysfunction
• Interventions: Drug: N acetyl cysteine; Other: normal saline

• Registration Number: NCT06486805
• Lead Sponsor: Kasr El Aini Hospital

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, 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).

Detailed Description

In a randomized controlled prospective study in a teaching hospital after approval of the ethical committee and informed consent 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 then 50 mg/kg over 4 hrs, and control groups (normal saline as placebo) (n = 17 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 Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-27
• Study Start: 2024-06-30
• Study First Posted: 2024-07-05
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-30
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAC	N acetyl cysteine	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
control	normal saline	received the same volume of normal saline as placebo

Primary Outcome Measures

Name	Time	Method
Malondialdahyde (MDA)	first postoperative day	MDA is a marker of oxidative stress and one of the end-products of lipid peroxidation. MDA level reflects the degree of lipid peroxidation.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kasralainy Faculty of Medicine; 🇪🇬 Cairo, Egypt