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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT03593408
Status
Recruiting
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Conditions

  • Drug Effect

Eligibility Criteria

Sex
ALL
Age
0 Days - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Dexmedetomidine — DRUG
    Administered for sedation management per hospital protocol
  • Fentanyl — DRUG
    Administered for sedation management per hospital protocol
  • Midazolam — DRUG
    Administered for sedation management per hospital protocol
  • Morphine — DRUG
    Administered for sedation management per hospital protocol

Study Details

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.

Key Dates

Start date
Feb 8, 2019
Status verified
Jan 2026
Primary completion
Aug 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Pediatric Patients on ECMO Support

Primary Outcome Measure

Change in plasma concentrations of dexmedetomidine [ Time Frame: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Viviane Nasr, MD
Viviane Nasr, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Boston Children's Hospital· Boston, MA

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