The Effects of ECMO on the Pharmacokinetics of Hydromorphone

Extracorporeal Membrane Oxygenation Clinical Trial

Official title:

The Effects of ECMO on the Pharmacokinetics of Hydromorphone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05565495
• Other study ID #: PKHM20210920
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: February 2023
• Source: Wuhan Union Hospital, China
• Contact: You Shang, Prof.
• Phone: 008602785351607
• Email: you_shanghust[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation

Intervention

Drug:
• 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 contents of hydromorphone and hydromorphone-3-glucuronide (main metabolite) were detected by quantitative liquid chromatography tandem mass spectrometry, and then A population pharmacokinetic model of hydromorphone in patients under ECMO was established.

Locations

Country	Name	City	State
China	Wuhan Union Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xiaobo Yang, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of distribution of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO	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.	Within 4 days
Secondary	Clearance of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO	Clearance of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO	Within 4 days