Paracetamol Metabolism Research in Postoperative Hepatic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Dosing and kinetics of paracetamolemia
研究概览
简要总结
The main objective of this study was to evaluate the 5-day kinetics of plasma paracetamol levels in postoperative major hepatic surgery (resection greater than or equal to three hepatic segments) compared with less extensive liver resection and hepatic re-intervention. The clearance of indocyanine green is a marker of hepatic perfusion but also of the proper hepatocyte functioning, if hemodynamic conditions are stable.
Some patients may be operated on up to four or five times in the liver. Moreover, these patients probably present an increased risk of postoperative hepatocellular insufficiency due to a quantitative and qualitative decrease in their hepatic parenchyma. It is therefore interesting to evaluate the use of paracetamol in this situation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients requiring surgery for hepatic resection by initiation under chest or laparoscopic without hepatocellular insufficiency,
- •ASA score 1 to 3 (American Society of Anesthesiologists score ranging from 1 to 5 evaluating the preoperative health status of a patient),
- •Verification of the understanding of the protocol,
排除标准
- •Patients classified ASA 4 or 5,
- •Allergy or intolerance to indocyanine green
- •Allergy or intolerance to paracetamol,
- •Taking of paracetamol the week before the intervention,
- •Patient less than 60 Kgs (because decrease of doses of paracetamol),
- •Emergency surgery, palliative surgery and surgical recovery,
- •Psychic disorder,
- •Contra-indication to a treatment used during the study,
- •incapable major,
- •Intellectual incapacity preventing proper understanding of the protocol,
- •Pregnant or nursing woman,
研究组 & 干预措施
major hepatic surgery
resection greater than or equal to three hepatic segments
干预措施: paracetamol (Drug)
major hepatic surgery
resection greater than or equal to three hepatic segments
干预措施: hepatic surgery (Procedure)
hepatic surgery
resection less than three hepatic segments
干预措施: paracetamol (Drug)
hepatic surgery
resection less than three hepatic segments
干预措施: hepatic surgery (Procedure)
hepatic surgery recovery
干预措施: paracetamol (Drug)
hepatic surgery recovery
干预措施: hepatic surgery (Procedure)
结局指标
主要结局
Dosing and kinetics of paracetamolemia
时间窗: during the 5 post-operative days
this determination of the plasma paracetamol dosage on D0 (H6: 6 hours after the end of the procedure) and D1 D2 D3 D4 D5 (samples taken at 6 am each day just before the injection of paracetamol whose administration hours will be 6h 12h 18h and midnight)
次要结局
- Dosage of urinary metabolites of paracetamol (paracetamol sulphate, paracetamol glucuronide)(At Day 1, day 3, day 5 post operative)
- Percentage of patients with paracetamolemia greater than 60 mg / mL(during the 5 post-operative days)
- Rate of postoperative hepatocellular insufficiency(at day 5)
- Plasma Disappearance Rate of indocyanine green (TDP-ICG) by LiMon®(At Day 1, day 3, day 5 post operative)
- Duration of hospitalization in perioperative intensive care(at 30 days)
- Composite characteristics of surgery.(at 30 days)
- Dosage of N-acetyl-cysteinyl paracetamol ( NAPQI)(At Day 1, day 3, day 5 post operative)
- Occurrence of complications related to hepatic failure(at day 5)
- Duration of total hospitalization.(at 30 days)
- Mortality(at 30 days)