Paracetamol-induced Liver Toxicity in Septic Patients
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- paracetamol induced liver toxicity
研究概览
简要总结
The investigators will examine the toxicity of therapeutic doses of paracetamol in patients in severe sepsis. Patients with fever and severe sepsis will be randomized to receive paracetamol or dypirone. The investigators will monitor blood glutathione and liver enzymes to look for potential toxicity.
详细描述
Paracetamol is metabolized in liver using the glutathione system. This detoxification system is depressed during severe illness such as sepsis, trauma etc. The study will examine the toxicity of therapeutic doses of paracetamol in patients in severe sepsis. We believe that during sepsis, paracetamol metabolites are not fully detoxified and therefore are toxic to the patient.
Patients with fever and severe sepsis will be randomized to receive paracetamol or dypirone. The investigators will monitor blood glutathione (as a surrogate marker for liver glutathione), liver enzymes and various clinical data (such as length of hospitalization) to look for a potential toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •hospitalized to int. med. dept. or ICU
- •body temp>38 and one or more from the following:
- •pulse>90 bpm
- •resp. rate>20/min or PaCO2<32 mmHg
- •WBC>12000 or <4000
- •one of the following:
- •hypotension
- •disturbed end-organ perfusion (confusion, oliguria, lactic acidosis etc.)
排除标准
- •acute / chronic liver disease
- •acute CNS disorder
- •current isoniazid treatment
- •alcoholism
- •active malignancy
- •pregnancy
- •TPN or PPN
研究组 & 干预措施
paracetamol treatment
干预措施: paracetamol (Drug)
control- dypirone treatment
干预措施: dypirone (Drug)
结局指标
主要结局
paracetamol induced liver toxicity
时间窗: every six months
defined as ALT and/or AST \> 1000 or reduction in glutathione below 50% of base line
次要结局
未报告次要终点