The Effects of ECMO on the Pharmacokinetics of Hydromorphone

Xiaobo Yang, MD

Status and phase: Enrolling; Phase 2

Conditions: Extracorporeal Membrane Oxygenation

Treatments: Drug: Hydromorphone

Study type: Interventional

Funder types: Other

Identifiers

NCT05565495

PKHM20210920

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Hydromorphone

Experimental group

Description:

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.

Treatment:

Drug: Hydromorphone