Role of N-Acetylcysteine in Non-Acetaminophen-Induced Liver Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Survival/Mortality rate
研究概览
简要总结
This randomized controlled trial evaluates whether oral N-acetylcysteine (NAC), given alongside standard supportive care, improves survival and reduces mortality in patients with non-acetaminophen-induced acute liver failure (ALF), compared to supportive care alone. Secondary objectives are to assess NAC's effect on length of hospital stay and improvement in liver function tests. Sixty-two adult patients (18-60 years) will be randomized 1:1 to NAC or control, with outcomes assessed at 28 days (survival/mortality) and day 4 (liver function tests).
详细描述
Acute liver failure carries high mortality, and in resource-limited settings like Pakistan, liver transplantation is often inaccessible, making pharmacologic adjuncts to supportive care important. Prior studies (Nabi et al. 2017; Mumtaz et al. 2009; Parkas et al. 2016) suggest oral NAC may improve survival and shorten hospital stay in non-acetaminophen ALF, though evidence remains limited. This trial will randomly assign eligible patients via computer-generated randomization to receive oral/NG NAC (140 mg/kg every 4 hours for 16 hours, then every 6-8 hours, continued for 3 days) plus standard supportive care, or standard supportive care alone. Standard care includes glucose monitoring, prophylactic antimicrobials, proton pump inhibitors, fluid/electrolyte management, anti-encephalopathy measures as needed, and fresh frozen plasma for bleeding. Patients will be followed for up to 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-60 years
- •Diagnosed with non-acetaminophen- induced acute hepatic failure (per operational definition/EASL criteria)
- •Etiology other than acetaminophen overdose (viral hepatitis HAV/HBV/HEV, non-acetaminophen drug-induced liver injury, or idiopathic)
- •No NAC treatment received for current episode prior to enrollment
排除标准
- •History of chronic liver disease or cirrhosis
- •Prior severe cardiac, renal, neurological, or infectious disease that could confound outcomes
- •Prior liver transplant or current transplant candidacy
- •Known allergy/contraindication to NAC
- •Pregnant women.
研究组 & 干预措施
Control Group
Standard supportive care protocol for acute liver failure (glucose control, antimicrobials, PPIs, fluid/electrolyte management, antiencephalopathy measures, FFP as needed). Intervention: Other: Standard Supportive Care
干预措施: Standard supportive care (Other)
NAC Group
Oral or nasogastric N-acetylcysteine, 140 mg/kg every 4 hours for the first 16 hours, then every 6-8 hours, continued for 3 days, plus standard supportive care.
Intervention: Drug: N-acetylcysteine
干预措施: N Acetyl Cysteine (Drug)
结局指标
主要结局
Survival/Mortality rate
时间窗: 28 days after enrollment
Proportion of patients alive (survival) vs. deceased (mortality) at day 28.
次要结局
- Length of hospital stay(From admission to discharge or death (up to 28 days))
研究者
somia iqtadar
Associate Professor
King Edward Medical University