Clinical trial

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

Name

IRB-P00028380

Description

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 arms

Trial start

2019-02-08

Estimated PCD

2024-08-01

Trial end

2024-12-01

Status

Recruiting

Treatment

Dexmedetomidine

Administered for sedation management per hospital protocol

Arms:

Pediatric Patients on ECMO Support

Fentanyl

Administered for sedation management per hospital protocol

Arms:

Pediatric Patients on ECMO Support

Midazolam

Administered for sedation management per hospital protocol

Arms:

Pediatric Patients on ECMO Support

Morphine

Administered for sedation management per hospital protocol

Arms:

Pediatric Patients on ECMO Support

Size

Primary endpoint

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

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2023-07-20

1 organization

3 products

1 drug

1 indication

Organization

Boston Children's Hospital

Product

Indication

Drug

Product

Product