N-Acetyl Cysteine Effect on Liver Function After Mitral Valve Replacement
- Conditions
- Oxidative StressLiver Dysfunction
- Interventions
- 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, 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Age from 18 to 70 years
- Both sexes
- Patients undergoing on-pump elective MVR with cold cardioplegia.
- 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 & 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) 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 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
Kasralainy Faculty of Medicine🇪🇬Cairo, Egypt