NCT02249039

Brief Summary

Critically ill infants and children who are mechanically ventilated are often given large doses of opiates and benzodiazepines to provide analgesia-sedation. These drugs significantly cause tolerance and dependence, depresses the drive to breathe, and thus prolongs the need for mechanical ventilation and the associated complications. We propose IV CLON could be used as effectively as DEX.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

4.3 years

First QC Date

August 11, 2014

Last Update Submit

February 26, 2021

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

  • Sedation

    Time spent (hrs) with a State Behavioral Scale \<1 without the concurrent escalation of opiates or sedatives within 24 hrs after starting the CLON or DEX

    2-8 weeks

Secondary Outcomes (2)

  • Frequency of cardiovascular occurrences

    2 - 8 weeks

  • Length of stay

    2-8 weeks

Study Arms (1)

intermittent IV CLON

EXPERIMENTAL

Mechanically ventilated infants and children receive intravenous intermittentClonidine

Drug: intermittent IV CLON

Interventions

intermittent IV CLONDRUG

Mechanically ventilated infants and children receive intravenous intermittent Clonidine instead of dexmedetomidine

Also known as: clonidine hydrochloride, Duraclon
intermittent IV CLON

Eligibility Criteria

Age1 Day - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants and children age: 0-12 months
  • Intubated and mechanically ventilated in the JHH PICU
  • Meet criteria for starting dexmedetomidine (per PICU protocol)

You may not qualify if:

  • Postoperative from complex congenital heart disease
  • Asphyxia
  • Traumatic Brain Injury
  • Major Chromosomal anomaly (Trisomy 13, 18)
  • Any infant or child who is receiving ECMO therapy
  • If death is considered imminent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sapna R Kudchadkar, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2014

First Posted

September 25, 2014

Study Start

September 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations

US(1)