Skip to content

The Effects of ECMO on the Pharmacokinetics of Hydromorphone

The Effects of ECMO on the Pharmacokinetics of Hydromorphone

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05565495
Enrollment
26
Registered
2022-10-04
Start date
2022-01-01
Completion date
2024-09-01
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extracorporeal Membrane Oxygenation

Keywords

Extracorporeal Membrane Oxygenation, Pharmacokinetics, Hydromorphone

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.

Interventions

DRUGHydromorphone

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.

Sponsors

Xiaobo Yang, MD
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Volume of distribution of hydromorphone and hydromorphone-3-glucuronide in patients on ECMOWithin 4 daysQuantitative 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

MeasureTime frameDescription
Clearance of hydromorphone and hydromorphone-3-glucuronide in patients on ECMOWithin 4 daysClearance of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO

Countries

China

Contacts

Primary ContactYou Shang, Prof.
you_shanghust@163.com008602785351607

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026