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

Kasr El Aini Hospital54 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Oxidative Stress Liver Dysfunction

Interventions

N acetyl cysteineDRUG

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

normal salineOTHER

the same volume of normal saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Kasralainy Faculty of Medicine

Cairo, Egypt

Outcomes

Primary Outcomes

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.

Time frame: Postoperative day one

Secondary Outcomes

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.

Time frame: preoperative and second postoperative day

liver function tests

ALT,AST,Bilirubin

Time frame: preoperative ,first ,and,second post operative days

hemodunamics

MAP, HR

Time frame: intraoperative

extubation time

time needed for extubation

Time frame: postoperative 24 hr.

tissue perfusion

Lactate

Time frame: preoperative ,first ,and,second post operative days

Data from ClinicalTrials.gov

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