Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05565495

The Effects of ECMO on the Pharmacokinetics of Hydromorphone

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Extracorporeal Membrane Oxygenation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydromorphone

Drug

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.

Primary outcomes

  1. Volume of distribution of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO

    Time frame: 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 outcomes

  1. Clearance of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO

    Time frame: Within 4 days

    Clearance of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO

Study contacts

Contact information is provided by the study sponsor or research team.

You Shang, Prof.

CONTACT

[email protected]

008602785351607

Sponsors and collaborators

Lead sponsor

Xiaobo Yang, MD

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2022
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.