Polypharmacy-related Adverse Events in Critically Ill Children

Delirium Clinical Trial

Official title:

Investigating Polypharmacy-related Adverse Events in Critically Ill Children

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03293927
• Other study ID #: Pro00084476
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 9, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: October 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Critical Illness
• Delirium

Intervention

Drug:
• Fentanyl
The patient will receive IV fentanyl
• Dexmedetomidine
The patient will receive IV dexemedetomidine

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in delirium scores as measured by CAPD score		up to 10 days
Secondary	Drug level associated with CAPD score		up to 10 days