Extracorporeal Membrane OxygenationPhase 2NCT05565495
The Effects of ECMO on the Pharmacokinetics of Hydromorphone
A Phase 2 study testing Hydromorphone in people with Extracorporeal Membrane Oxygenation, run by Xiaobo Yang, MD at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation
- What is being tested?
- Hydromorphone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 80;
- Using hydromorphone for pain relief;
- Using ECMO for more than 96h
Who cannot join
- Allergic to hydromorphone;
- Use of CRRT during ECMO;
- Liver function Child-Pugh B, C grade;
- Pregnancy;
- Intestinal obstruction;
- Refused to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430022
You Shang, 15972127819, you_shanghust@163.com
About this study
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.
Read the 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.
- Conditions
- Extracorporeal Membrane Oxygenation
- Being tested
- Hydromorphone
- Keywords
- Extracorporeal Membrane Oxygenation, Pharmacokinetics, Hydromorphone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Hydromorphone | Experimental | 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 content of hydromorphone and hydromorphone-3-glucuronide (the main metabolite) was detected by quantitative liquid chromatography tandem mass spectrometry. And then a population pharmacokinetic model of hydromorphone in patients under ECMO was established. Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 4 days
Secondary outcomes (1)
Clearance of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO
Clearance of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO
Measured: Within 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Jan 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaobo Yang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaobo Yang, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565495
- Sponsor's protocol ID
- PKHM20210920
- Status last verified
- Aug 2024
- First submitted
- 13 Sep 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 42438343
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of ECMO on the Pharmacokinetics of Hydromorphone
- ClinicalTrials.gov ID
- NCT05565495
- Acronym / sponsor ID
- PKHM20210920
- Conditions
- Extracorporeal Membrane Oxygenation
- Keywords
- Extracorporeal Membrane Oxygenation, Pharmacokinetics, Hydromorphone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Xiaobo Yang, MDUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydromorphone | Experimental | Drug: HydromorphoneHydromorphone 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 content of hydromorphone and hydromorphone-3-glucuronide (the main metabolite) was detected by quantitative liquid chromatography tandem mass spectrometry. And then a population pharmacokinetic model of hydromorphone in patients under ECMO was established. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18 and 80;
- Using hydromorphone for pain relief;
- Using ECMO for more than 96h
Key exclusion criteria (6 listed)
- Allergic to hydromorphone;
- Use of CRRT during ECMO;
- Liver function Child-Pugh B, C grade;
- Pregnancy;
- Intestinal obstruction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydromorphoneHydromorphone 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. | Drug | Hydromorphone |
Primary outcome
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.
1 secondary outcome
Clearance of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO
Time frame: Within 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 42438343Gao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydromorphone in people with Extracorporeal Membrane Oxygenation, run by Xiaobo Yang, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact You Shang, Prof. (008602785351607, you_shanghust@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of distribution of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO (time frame: Within 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05565495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.