The Effects of ECMO on the Pharmacokinetics of Hydromorphone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-09-01

Brief Summary

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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.

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Detailed Description

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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

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Extracorporeal Membrane Oxygenation

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hydromorphone

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.

Group Type EXPERIMENTAL

Hydromorphone

Intervention Type 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.

Interventions

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Hydromorphone

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No