Drug EffectNCT03593408
Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support
An observational study of Drug Effect, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 0 days to 17 years
- Conditions the study is for
- Drug Effect
- What is being tested?
- Dexmedetomidine, Fentanyl and Midazolam
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2019to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- supported on ECMO
- receiving one or a combination of the following drugs dexmedetomidine, fentanyl, midazolam or morphine as part of sedation management
Who cannot join
- -none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Viviane Nasr, MD
Viviane Nasr, MD
About this study
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.
- Conditions
- Drug Effect
- Being tested
- Dexmedetomidine, Fentanyl, Midazolam, Morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Administered for sedation management per hospital protocol
FentanylDrug
Administered for sedation management per hospital protocol
MidazolamDrug
Administered for sedation management per hospital protocol
MorphineDrug
Administered for sedation management per hospital protocol
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Patients on ECMO Support | Not described Receives: Drug: Dexmedetomidine; Drug: Fentanyl; Drug: Midazolam; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma concentrations of dexmedetomidine
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start8 Feb 2019
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug EffectStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viviane Nasr, Boston Children's Hospital
- Investigators
- Viviane Nasr, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593408
- Sponsor's protocol ID
- IRB-P00028380
- Status last verified
- Jan 2026
- First submitted
- 26 Jun 2018
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support
- ClinicalTrials.gov ID
- NCT03593408
- Acronym / sponsor ID
- IRB-P00028380
- Conditions
- Drug Effect
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Patients on ECMO Support | – | Drug: Dexmedetomidine, Drug: Fentanyl, Drug: Midazolam, Drug: Morphine |
Who may qualify
- Ages
- 0 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (2 listed)
- supported on ECMO
- receiving one or a combination of the following drugs dexmedetomidine, fentanyl, midazolam or morphine as part of sedation management
Key exclusion criteria (1 listed)
- -none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAdministered for sedation management per hospital protocol | Drug | Pediatric Patients on ECMO Support |
| FentanylAdministered for sedation management per hospital protocol | Drug | Pediatric Patients on ECMO Support |
| MidazolamAdministered for sedation management per hospital protocol | Drug | Pediatric Patients on ECMO Support |
| MorphineAdministered for sedation management per hospital protocol | Drug | Pediatric Patients on ECMO Support |
Primary outcome
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
change in plasma concentrations of fentanyl
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Viviane Nasr, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Effect, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viviane Nasr, MD (617-355-6225, viviane.nasr@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.