The Effects of ECMO on the Pharmacokinetics of Hydromorphone

NCT05565495 | Recruiting Phase 2

• 1 other identifier: PKHM20210920
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extracorporeal Membrane Oxygenation

Keywords

Extracorporeal Membrane Oxygenation; Pharmacokinetics; Hydromorphone

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 4 days

Secondary Outcomes (1)

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

  Within 4 days

Study Arms (1)

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.

Drug: Hydromorphone

Interventions

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.

Hydromorphone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18 and 80;
• Using hydromorphone for pain relief;
• Using ECMO for more than 96h

You may not qualify if:

• Allergic to hydromorphone;
• Use of CRRT during ECMO;
• Liver function Child-Pugh B, C grade;
• Pregnancy;
• Intestinal obstruction;
• Refused to sign the informed consent.

Sponsors & Collaborators

• Xiaobo Yang, MD: lead

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Interventions

Hydromorphone

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

You Shang, Prof.

CONTACT

008602785351607; you_shanghust@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: October 4, 2022
• Study Start: January 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

CN (1)