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

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

2. 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

3. 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

4. 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.

1. First posted20 Jul 2018
2. Study start8 Feb 2019
3. Primary completion1 Aug 2027 (estimated)
4. 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.