The Effect of N-Acetylcysteine on Liver Functions After Mitral Valve Replacement: A Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- normal saline
- Conditions
- Oxidative Stress
- Sponsor
- Kasr El Aini Hospital
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Malondialdahyde (MDA)
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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).
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.
Investigators
Ahmed Mohamed Mohamed Elhaddad
Assisstent professor
Kasr El Aini Hospital
Eligibility Criteria
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.
Arms & Interventions
control
received the same volume of normal saline as placebo
Intervention: 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
Intervention: N acetyl cysteine
Outcomes
Primary Outcomes
Malondialdahyde (MDA)
Time Frame: Postoperative day one
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 Outcomes
- liver function tests(preoperative ,first ,and,second post operative days)
- hemodunamics(intraoperative)
- tissue perfusion(preoperative ,first ,and,second post operative days)
- MDA(preoperative and second postoperative day)
- extubation time(postoperative 24 hr.)