Effects of ECMO on hydromorphone pharmacokinetics
The Effects of ECMO on the Pharmacokinetics of Hydromorphone
This study is testing how hydromorphone behaves in the body of patients on ECMO to figure out the best way to dose the medication for them.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05565495 on ClinicalTrials.gov |
What this trial studies
This study aims to establish a population pharmacokinetic model for hydromorphone in patients undergoing extracorporeal membrane oxygenation (ECMO). Participants will receive a continuous intravenous infusion of hydromorphone for 72 hours while blood samples are collected at various time points to analyze drug levels. The goal is to recommend an appropriate dosing regimen based on the effective concentration of hydromorphone in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who are using hydromorphone for pain relief and have been on ECMO for more than 96 hours.
Not a fit: Patients who are allergic to hydromorphone, pregnant, or have significant liver dysfunction will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize pain management for patients on ECMO by providing tailored dosing recommendations for hydromorphone.
How similar studies have performed: While pharmacokinetic studies in ECMO patients are not extensively documented, similar approaches have shown promise in optimizing drug dosing in critically ill populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- Wuhan Union Hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: You Shang, Prof.
- Email: you_shanghust@163.com
- Phone: 008602785351607
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.