Status:
WITHDRAWN
Polypharmacy-related Adverse Events in Critically Ill Children
Lead Sponsor:
Duke University
Conditions:
Delirium
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to learn how 2 medications (fentanyl and dexmedetomidine) affect how sick children think and interact with their environments.
Eligibility Criteria
Inclusion
- Ages 2-\<18 at the time of enrollment
- Admitted to the Duke PICU or PCICU
- Planned or anticipated mechanically ventilation for ≥2 days
- Require sedation to maintain mechanical ventilation
- No contraindication to receipt of fentanyl or dexmedetomidine per clinician judgment
- Availability and willingness of the parent/legal guardian to provide written informed consent
Exclusion
- Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
- Previous participation in this study
- Planned receipt of sedatives other than fentanyl or dexmedetomidine
- Participants with any of the following diagnoses: traumatic brain injury, intracranial hemorrhage, baseline neurodevelopmental delay, status epilepticus, or requiring inotropic support for hemodynamic stability.
- Renal failure requiring renal replacement therapy
- Hepatic failure
- Support with extracorporeal membrane oxygenation
Key Trial Info
Start Date :
April 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03293927
Start Date
April 9 2018
End Date
July 1 2019
Last Update
July 18 2019
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710