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Trial record 99 of 326 for:    clonidine

Intravenous Clonidine for Sedation in Infants and Children Who Are Mechanically Ventilated - Dosing Finding Study

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ClinicalTrials.gov Identifier: NCT02249039
Recruitment Status : Recruiting
First Posted : September 25, 2014
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Complication Drug: intermittent IV CLON Phase 1 Phase 2

Detailed Description:
All critically ill mechanically ventilated infants and children receive intravenous analgesic-sedatives which often include opiates and benzodiazepines (BENZO). Undesirable side effects from these drugs include respiratory depression, tolerance and dependence. Alpha 2-adrenergic receptor agonists, dexmedetomidine (DEX) and clonidine (CLON) have excellent sedative-analgesics effects, do not cause respiratory depression and are opiate/BENZO sparing. While both are efficacious in providing sedation, several factors have led to a substantial increase in the use of the newer drug DEX over the more established drug CLON in adults, children and infants. However, studies to guide therapy and dosing for infants and children are lacking. While these infants and children do require less opiate/BENZO therapy and fewer days on mechanical ventilation, they quickly develop tolerance to and have significant withdrawal from DEX. This necessitates protracted weaning of DEX and longer length of stay in the pediatric intensive care unit (PICU) since DEX can only be administered as a continuous intravenous (IV) infusion. CLON, on the other hand, has a longer half-life and has formulations that allow for continuous or intermittent IV and oral administration. Dr. Gauda has an approved IND to use the epidural formulation of CLON intravenously in infants and children. The purpose of this pilot study is to determine the effective IV dosing scheme of CLON that can be safely used as an adjunct to analgesic-sedation management for infants and children in the PICU. It will include a total of 24 infants and children with 4 CLON and DEX exposed in each age stratum: 0-3, 4-6, and 7-12 months. We hypothesize that IV CLON can achieve optimal sedation and reduce the need for opiate/BENZO therapy in critically ill infants and children who would otherwise receive DEX, and thus, reduce the length of stay in the PICU. Data from this study will be used to inform a larger randomized trial and will directly benefit infants and children in Baltimore who are critically ill. Funds are requested to cover the cost of the CLON drug levels and the investigational pharmacy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Clonidine for Sedation in Infants and Children Who Are Mechanically Ventilated - Dosing Finding Study
Study Start Date : September 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intermittent IV CLON
Mechanically ventilated infants and children receive intravenous intermittentClonidine
Drug: intermittent IV CLON
Mechanically ventilated infants and children receive intravenous intermittent Clonidine instead of dexmedetomidine
Other Names:
  • clonidine hydrochloride
  • Duraclon




Primary Outcome Measures :
  1. Sedation [ Time Frame: 2-8 weeks ]
    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


Secondary Outcome Measures :
  1. Frequency of cardiovascular occurrences [ Time Frame: 2 - 8 weeks ]

    Frequency of cardiovascular occurrences i. ≥10 torr reduction in mean arterial blood pressure (MAP) ii. 20% drop in HR from the infant's baseline iii. Changes in HR or Blood pressure that triggers an intervention by the clinical team such as: -

    1. Adding or escalating cardiotonic meds
    2. holding the dose of timed sedative/analgesia

  2. Length of stay [ Time Frame: 2-8 weeks ]
    Length of stay in PICU for sedative-analgesic therapy after stabilization and extubation.



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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249039


Contacts
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Contact: Sapna R Kudchadkar, MD 410-955-6412 sapna@jhmi.edu
Contact: Pam Melvin, RN 410-955-6412 pam@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Sapna R Kudchadkar, MD    410-955-6412    sapna@jhmi.edu   
Contact: Pam Melvin, RN    410-955-6412    pam@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Sapna R Kudchadkar, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02249039     History of Changes
Other Study ID Numbers: IRB00109563
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Additional relevant MeSH terms:
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Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action