The Effect of N-Acetylcysteine on Liver Functions After Mitral Valve Replacement: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Malondialdahyde (MDA)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
quadrible blinded
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 70 years
- •Both sexes
- •Patients undergoing on-pump elective MVR with cold cardioplegia.
排除标准
- •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.
研究组 & 干预措施
control
received the same volume of normal saline as placebo
干预措施: normal saline (Other)
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
干预措施: N acetyl cysteine (Drug)
结局指标
主要结局
Malondialdahyde (MDA)
时间窗: 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.
次要结局
- 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.)
研究者
Ahmed Mohamed Mohamed Elhaddad
Assisstent professor
Kasr El Aini Hospital