Polypharmacy-related Adverse Events in Critically Ill Children

NCT03293927 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: Pro00084476
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

children, mechanically ventilated, fentanyl, dexmedetomidine, delirium, polypharmacy

Outcome Measures

Primary Outcomes (1)

• Change in delirium scores as measured by CAPD score

  up to 10 days

Secondary Outcomes (1)

• Drug level associated with CAPD score

  up to 10 days

Study Arms (4)

Fentanyl + Dexmedetomidine

EXPERIMENTAL

Drug: Fentanyl; Drug: Dexmedetomidine

Dexmedetomidine + Fentanyl

EXPERIMENTAL

Drug: Fentanyl; Drug: Dexmedetomidine

Fentanyl only

EXPERIMENTAL

Drug: Fentanyl

Dexmedetomidine only

EXPERIMENTAL

Drug: Dexmedetomidine

Interventions

Fentanyl DRUG

The patient will receive IV fentanyl

Dexmedetomidine + Fentanyl; Fentanyl + Dexmedetomidine; Fentanyl only

Dexmedetomidine DRUG

The patient will receive IV dexemedetomidine

Dexmedetomidine + Fentanyl; Dexmedetomidine only; Fentanyl + Dexmedetomidine

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Delirium

Interventions

Fentanyl; Dexmedetomidine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Study Officials

• Kanecia Zimmerman, MD

  Duke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 26, 2017
• Study Start: April 9, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 18, 2019

Record last verified: 2018-10

Locations

US (1)