The Effects of ECMO on the Pharmacokinetics of Hydromorphone

Phase 2

Recruiting

• Conditions: Extracorporeal Membrane Oxygenation
• Interventions: Drug: Hydromorphone

• Registration Number: NCT05565495
• Lead Sponsor: Xiaobo Yang, MD

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-10-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Between the ages of 18 and 80;
• Using hydromorphone for pain relief;
• Using ECMO for more than 96h

Exclusion Criteria

• Allergic to hydromorphone;
• Use of CRRT during ECMO;
• Liver function Child-Pugh B, C grade;
• Pregnancy;
• Intestinal obstruction;
• Refused to sign the informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Hydromorphone	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.

Primary Outcome Measures

Name	Time	Method
Volume of distribution of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO	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.

Secondary Outcome Measures

Name	Time	Method
Clearance of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO	Within 4 days	Clearance of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO

Trial Locations

Locations (1)

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China