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Recruiting NCT05565495

The Effects of ECMO on the Pharmacokinetics of Hydromorphone

Phase II Interventional Extracorporeal Membrane Oxygenation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydromorphone.
Who it may be relevant to
Registry conditions: Extracorporeal Membrane Oxygenation. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Volume of distribution of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO [Time frame: Within 4 days]
Secondary outcome measures (1)
  • Clearance of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO [Time frame: Within 4 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Wuhan Union Hospital — Wuhan

Publications

  • Gao X, Yao L, Zeng F, Zhang H, Wu Y, Huang Y, Hong Z, Shu H, Zhang J, Yang X, Zou X, Shang Y. Population Pharmacokinetics of Intravenous Infusion of Hydromorphone in Critically Ill Patients Supported by Extracorporeal Membrane Oxygenation. Clin Transl Sci. 2026 Jul;19(7):e70666. doi: 10.1111/cts.70666. PMID 42438343

Identifiers

NCT: NCT05565495 · PKHM20210920

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗