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

NCT ID: NCT03593408

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-08

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Drug Effect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric Patients on ECMO Support

Dexmedetomidine

Intervention Type DRUG

Administered for sedation management per hospital protocol

Fentanyl

Intervention Type DRUG

Administered for sedation management per hospital protocol

Midazolam

Intervention Type DRUG

Administered for sedation management per hospital protocol

Morphine

Intervention Type DRUG

Administered for sedation management per hospital protocol

Interventions

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Dexmedetomidine

Administered for sedation management per hospital protocol

Intervention Type DRUG

Fentanyl

Administered for sedation management per hospital protocol

Intervention Type DRUG

Midazolam

Administered for sedation management per hospital protocol

Intervention Type DRUG

Morphine

Administered for sedation management per hospital protocol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

0 Days

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Viviane Nasr

Cardiac Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Viviane Nasr, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Viviane Nasr, MD

Role: CONTACT

617-355-6225

Facility Contacts

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Viviane Nasr, MD

Role: primary

Other Identifiers

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IRB-P00028380

Identifier Type: -

Identifier Source: org_study_id

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