Observational Study Assessing Cytochrome P450 Dependant Paracetamol Metabolites Following Liver Resection.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Urinary cysteine
研究概览
简要总结
This observational study will assess the metabolic pathways of paracetamol that are utilised after liver resection.
详细描述
Paracetamol is normally metabolised by the glucuronidation and sulfation of paracetamol to non toxic end products. If paracetamol is administered in supra-therapeutic doses this pathway becomes saturated and an alternative pathway is utilised. This results in a toxic metabolite called N-acetyl-p-benzoquinone imine (NAPQI). If NAPQI is not metabolised by glutathione to cysteine and mercapturic acid, then NAPQI bind to hepatic cells resulting in necrosis and hepatotoxicity.
Therefore the investigators plan to measure the levels of the paracetamol metabolites in patient undergoing liver resection.
Patients will undergo liver resection according to their onco-surgical requirements. As part of the normal post operative care they will receive 1g paracetamol every six hours unless stated otherwise by the operating surgeon. Urinary samples will be taken for the first 4 post operative days and used for analysis of the urinary paracetamol metabolite levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing liver surgery
排除标准
- •Contra-indication to paracetamol
- •Inability to give written, informed consent.
- •Jaundice (Bilirubin > 100 μmol/L).
- •Liver resection combined with secondary surgical procedure.
- •Age < 18 years.
- •Pregnant women.
结局指标
主要结局
Urinary cysteine
时间窗: Post operative days 1-4
次要结局
- mercapturic acid(post operative days 1-4)
- Glutathione(day of surgery and post operative days 1 and 3)
- Paracetamol level(day of surgery and post operative days 1 and 3)