Comparative Study of Twelve Hours Versus Twenty One Hours Protocols of Intravenous N-Acetyl Cystiene Treatment in Paracetamol Toxicity at Assiut University Childern's Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- 1-Change in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
研究概览
简要总结
Evaluation of differences between the 21 h NAC regimen protocol and the 12 h NAC regimen protocol in the treatment of paracetamol toxicity (over dose) for cases presented early and late to Assiut University Hospitals in terms of safety and efficiecy.
详细描述
Acetamenphen is an analgesic and antipyretic drug . It is used as an active ingredient in many over-the-counter and prescription medications. It is generally considered safe at therapeutic doses. However, toxicity can be caused by multiple supratherapeutic doses or an acute, high overdose .
Acetaminophen is metabolized by the cytochrome P450 2E1 to N-acetyl para- benzoquinone-imine (NAPQI), a metabolit extremely toxic to the liver. This process depletes glutathione; thus, NAPQI binds to cellular and mitochondrial proteins to form adducts, impairing mitochondrial respiration and generating oxidative stress .
N-Acetylcysteine (NAC) is a 20-21-hour regimen which involves 3 weight related infusions. The first 150mg/kg is given over 1 hour, second 50mg/kg given over 4 hours and the last 100mg/kg given over 16 hours. This has been the optimal available therapy since 1980 .
Several evidence shows various adverse effect of this regimen which include anaphylactoid reaction, nausea, vomiting and medication error .
Recently the intravenous regimen has been simplified from a three-bag regimen to a two-bag regimen in many parts of the world, which has reduced the early very high concentrations and therefore adverse reaction rate .
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All cases admitted to Assiut University Hospitals with history of acute paracetamol overdose ingestion .
排除标准
- •* Co-ingestion of other hepatotoxic drugs .
- •Pre-existing liver diseases: Chronic hepatitis B or C, Autoimmune hepatitis, Wilson's disease, Known cirrhosis , Sepsis, shock, or hypoxic injury affecting the liver.
- •Hemolytic disorders causing abnormal LFTs.
- •Genetic or metabolic diseases that affect liver functions.
研究组 & 干预措施
patients early adminstared 21 h NAC protocol in treatment of paracetamol toxicity
干预措施: Evidence-based medical care for paracetamol toxicity (Other)
patients early adminstared 12 h NAC protocol in treatment of paracetamol toxicity
干预措施: Evidence-based medical care for paracetamol toxicity (Other)
patients late adminstared 21 h NAC protocol in treatment of paracetamol toxicity
干预措施: Evidence-based medical care for paracetamol toxicity (Other)
patients late adminstared 12 h NAC protocol in treatment of paracetamol toxicity
干预措施: Evidence-based medical care for paracetamol toxicity (Other)
结局指标
主要结局
1-Change in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
时间窗: 1- Day 2
1-Mean change in ALT and AST levels (IU/L) from baseline to end of treatment
change in serum creatinine level
时间窗: Day 2
Mean change in serum creatinine (mg/dL) from baseline to end of treatment.
Incidence of adverse drug reactions
时间窗: Day 2
Number of participants who develop adverse drug reactions including nausea, vomiting, or anaphylactoid reactions during treatment
次要结局
- rate of clinical recovery(immediately after the intervention)
- incidence of serious complications(immediately after the intervention)
研究者
Sabreen Rabee Hasan Mohmed
demonstrator of clinical toxicology
Assiut University