NCT05565495

The Effects of ECMO on the Pharmacokinetics of Hydromorphone

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Xiaobo Yang, MD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2022-10-04
• Last updated: 2024-08-06

Locations

1 site across 1 country: China