The Effects of ECMO on the Pharmacokinetics of Hydromorphone

ConditionExtracorporeal Membrane Oxygenation

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorXiaobo Yang, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Between the ages of 18 and 80;

Using hydromorphone for pain relief;

Using ECMO for more than 96h

Disqualifiers

Allergic to hydromorphone;

Use of CRRT during ECMO;

Liver function Child-Pugh B, C grade;

Pregnancy;

Trial design

Design model

Sequential

Treatments tested in this trial

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.

Treatment groups

26 Participants

are divided into 1 treatment group

Group A: HydromorphoneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Within 4 days

Secondary outcomes

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

Time frame

Within 4 days

Sponsors and contacts

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Xiaobo Yang, MD

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Sponsor institution

Source ClinicalTrials.gov

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