Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support

Drug Effect Clinical Trial

Official title:

Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03593408
• Other study ID #: IRB-P00028380
• Status: Recruiting
• Start date: February 8, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: July 2023
• Source: Boston Children's Hospital
• Contact: Viviane Nasr, MD
• Phone: 617-355-6225
• Email: viviane.nasr[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will measure plasma concentrations of dexmedetomidine, fentanyl, morphine and midazolam in pediatric patients supported with extracorporeal membrane oxygenation (ECMO) aiming to understand the pharmacokinetics of these drugs in this setting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2024
• Est. primary completion date: August 1, 2024
• Gender: All
• Age group: 0 Days to 17 Years

Eligibility

Inclusion Criteria:

• supported on ECMO

• receiving one or a combination of the following drugs dexmedetomidine, fentanyl, midazolam or morphine as part of sedation management

Exclusion Criteria:

-none

Related Conditions & MeSH terms

• Drug Effect

Intervention

Drug:
• Dexmedetomidine
Administered for sedation management per hospital protocol
• Fentanyl
Administered for sedation management per hospital protocol
• Midazolam
Administered for sedation management per hospital protocol
• Morphine
Administered for sedation management per hospital protocol

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma concentrations of dexmedetomidine		Throughout the duration of sedation management with dexmedetomidine at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped
Primary	change in plasma concentrations of fentanyl		Throughout the duration of sedation management with fentanyl at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped
Primary	change in plasma concentrations of morphine		Throughout the duration of sedation management with morphine at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped
Primary	change in plasma concentrations of midazolam		Throughout the duration of sedation management with midazolam at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped