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Polypharmacy-related Adverse Events in Critically Ill Children

Primary Purpose

Delirium

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Fentanyl

Dexmedetomidine

About this trial

This is an interventional treatment trial for Delirium focused on measuring children, mechanically ventilated, fentanyl, dexmedetomidine, delirium, polypharmacy

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Fentanyl + Dexmedetomidine

Dexmedetomidine + Fentanyl

Fentanyl only

Dexmedetomidine only

Arm Description

Outcomes

Primary Outcome Measures

Change in delirium scores as measured by CAPD score

Secondary Outcome Measures

Drug level associated with CAPD score

Full Information

NCT ID

NCT03293927

First Posted

September 21, 2017

Last Updated

July 16, 2019

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT03293927

Brief Title

Polypharmacy-related Adverse Events in Critically Ill Children

Official Title

Investigating Polypharmacy-related Adverse Events in Critically Ill Children

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Withdrawn

Why Stopped

No participants enrolled in study.

Study Start Date

April 9, 2018 (Actual)

Primary Completion Date

July 1, 2019 (Anticipated)

Study Completion Date

July 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Delirium

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fentanyl + Dexmedetomidine

Arm Type

Experimental

Arm Title

Dexmedetomidine + Fentanyl

Arm Type

Experimental

Arm Title

Fentanyl only

Arm Type

Experimental

Arm Title

Dexmedetomidine only

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Fentanyl

Intervention Description

The patient will receive IV fentanyl

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Intervention Description

The patient will receive IV dexemedetomidine

Primary Outcome Measure Information:

Title

Change in delirium scores as measured by CAPD score

Time Frame

up to 10 days

Secondary Outcome Measure Information:

Title

Drug level associated with CAPD score

Time Frame

up to 10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kanecia Zimmerman, MD

Organizational Affiliation

Duke

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Polypharmacy-related Adverse Events in Critically Ill Children

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