Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support
1 other identifier
observational
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2018
CompletedFirst Posted
Study publicly available on registry
July 20, 2018
CompletedStudy Start
First participant enrolled
February 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 9, 2026
January 1, 2026
7.5 years
June 26, 2018
January 8, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
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
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
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
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
Study Arms (1)
Pediatric Patients on ECMO Support
Interventions
Administered for sedation management per hospital protocol
Administered for sedation management per hospital protocol
Administered for sedation management per hospital protocol
Administered for sedation management per hospital protocol
Eligibility Criteria
All pediatric patients who present to Boston Children's Hospital (BCH) and supported on ECMO and receiving one or a combination of the following drugs dexmedetomidine, fentanyl, midazolam or morphine as part of the sedation management.
You may qualify if:
- supported on ECMO
- receiving one or a combination of the following drugs dexmedetomidine, fentanyl, midazolam or morphine as part of sedation management
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Viviane Nasr, MD
Boston Children's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cardiac Anesthesiologist
Study Record Dates
First Submitted
June 26, 2018
First Posted
July 20, 2018
Study Start
February 8, 2019
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 9, 2026
Record last verified: 2026-01