The Effects of ECMO on the Pharmacokinetics of Hydromorphone
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Volume of distribution of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO
研究概览
简要总结
The purpose of this study was to establish a population pharmacokinetic (PPK) model of hydromorphone in patients under ECMO, and to recommend a dosing regimen when the target effective concentration was reached.
详细描述
A population pharmacokinetic (PPK) model of hydromorphone in patients under ECMO was established. The patients were given hydromorphone 0.03mg/kg/h by continuous intravenous infusion for 72 hours for analgesia. Blood samples were collected at different time points before and after administration, and quantitative liquid chromatography tandem mass spectrometry was used to detect hydromorphone and its main metabolite, hydromorphone-3-glucuronide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18 and 80;
- •Using hydromorphone for pain relief;
- •Using ECMO for more than 96h
排除标准
- •Allergic to hydromorphone;
- •Use of CRRT during ECMO;
- •Liver function Child-Pugh B, C grade;
- •Pregnancy;
- •Intestinal obstruction;
- •Refused to sign the informed consent.
研究组 & 干预措施
Hydromorphone
Hydromorphone was administered intravenously at a rate of 0.03 mg/kg/h for 72 h for analgesia. Blood samples were collected before administration and at different time points after administration, and the content of hydromorphone and hydromorphone-3-glucuronide (the main metabolite) was detected by quantitative liquid chromatography tandem mass spectrometry. And then a population pharmacokinetic model of hydromorphone in patients under ECMO was established.
干预措施: Hydromorphone (Drug)
结局指标
主要结局
Volume of distribution of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO
时间窗: Within 4 days
Quantitative liquid chromatography-tandem mass spectrometry was used to detect the contents of hydromorphone and hydromorphone -3- glucuronide in blood samples at various time points, so as to obtain the pharmacokinetics of continuous intravenous infusion of hydromorphone for 72 hours during ECMO.
次要结局
- Clearance of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO(Within 4 days)
研究者
Xiaobo Yang, MD
Clinical Professor
Wuhan Union Hospital, China