Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects
A Phase III Randomized, Double-blind, Dose-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Dexmedetomidine in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit Subjects
1 other identifier
interventional
175
2 countries
37
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine (DEX) in intubated and mechanically ventilated pediatric intensive care unit (PICU) subjects. The key study objectives are:
- To characterize the loading and maintenance dosing of DEX by age group and overall medical condition of pediatric subjects
- To evaluate the safety and efficacy of loading and maintenance infusions for sedation in initially intubated and mechanically ventilated PICU subjects
- To explore the exposure-response relationship between dose of DEX and clinical measures of sedation and safety
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2010
Shorter than P25 for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2009
CompletedFirst Posted
Study publicly available on registry
April 3, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
October 30, 2014
CompletedAugust 14, 2015
July 1, 2015
1 year
March 31, 2009
May 30, 2014
July 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects That do Not Require Rescue Midazolam (MDZ) for Sedation Based on Achieving and Maintaining a Target University of Michigan Sedation Scale (UMSS) Score of 1 to 3 While Intubated.
Clinical Score Level of Sedation 0 Awake/Alert 1. Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2. Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3. Deeply sedated: Deep sleep, arousable only with significant physical stimulation. 4. Unarousable
6 to 24 hours
Secondary Outcomes (5)
Absolute Time on Study Drug That the Subject is in a UMSS Range of 1 to 3 While Intubated
6 to 24 hours
Absolute Time on Study Drug That the Subject is Out of the Target Sedation Range (UMSS <1 or >3) While Intubated
6 to 24 hours
Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated
6 to 24 hours
Time to First Dose of Rescue Medication for Sedation and Analgesia
6 to 24 hours
Time to Successful Extubation
6 to 24 hours
Study Arms (2)
Dexmedetomidine Low Dose
ACTIVE COMPARATORDexmedetomidine High dose
ACTIVE COMPARATORInterventions
Study drug titrated up or down to maintain target UMSS range.
Rescue medication for sedation according to UMSS scores
Rescue medication for pain based on UMSS scores
Rescue medication for pain based on UMSS scores.
Eligibility Criteria
You may qualify if:
- Initially intubated and mechanically ventilated pediatric subjects (≥1 month \[birth age corrected for prematurity\] to \<17 years of age) in an intensive care setting. The means by which the subject is intubated may include nasotracheal, endotracheal or via tracheotomy. The subject must be mechanically ventilated prior to and during the commencement of study drug.
- Anticipated to require a minimum of 6 hours of continuous intravenous sedation.
- American Society of Anesthesiologists (ASA) classification of 1, 2, 3 or 4.
- A UMSS score of 1, 2, 3 or 4 at the start of infusion of study drug.
- A dose has been established for this subject's age based upon the diagnosis procedures.
- Status post cardiopulmonary bypass (s/p CPB):
- Low dose group: Loading dose: 0.2 mcg/kg Maintenance dose titration range (0.025-0.5 mcg/kg/hr)
- High dose group: Loading dose: 0.5 mcg/kg Maintenance dose titration range (0.1-0.7 mcg/kg/hr)
- All other diagnoses:
- Low dose group: Loading dose: 0.3 mcg/kg Maintenance dose titration range (0.05- 0.5mcg/kg/hr)
- High dose group: Loading dose: 0.6 mcg/kg Maintenance dose titration range (0.2 - 1.4 mcg/kg/hr)
- If female, subject is non-lactating and is either:
- Not of childbearing potential, defined as pre-menarche, or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.
- Of childbearing potential but is not pregnant at time of baseline.
- Subject's parent(s) or legal guardian(s) has/have voluntarily signed and dated the informed consent document approved by the Institutional Review Board. Assent will be obtained where age-appropriate and according to state regulations.
You may not qualify if:
- Pediatric subjects with neurological conditions that prohibit an evaluation of sedation in the opinion of the investigator (e.g. increased intracranial pressure or extensive brain surgery).
- The infusion pump minimal capacity cannot accommodate the lowest possible maintenance infusion rate of study drug based on subject's weight.
- Subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires.
- Hypotension that persist beyond a 15 min of re-assessments prior to starting study drug:
- Age 1 month to ≤6 months old: systolic blood pressure (SBP) \<60 (millimeters of mercury) mmHg
- Age \>6 months to \<2 yrs old: SBP \<70 mmHg
- Age \>2 to \<12 yrs old: SBP \<80 mmHg
- Age \>12 to \<17 yrs old: SBP \<90 mmHg
- Pre-existing bradycardia that persists beyond a 15 min period of re-assessment prior to starting study drugs:
- Age 1 month to \<2 months old: HR \<90 beats per min (bpm)
- Age ≥2 months to \<12 months old: HR \<80 bpm
- Age ≥12 months to \<2 yrs old: HR \<70 bpm
- Age ≥ 2 to \<12 yrs old: HR \<60 bpm
- Age ≥ 12 to \<17 yrs old: HR \<50 bpm
- Serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT): 1 month -12 months: \>165 U/L; \>12 months to \<17 years: ≥100 U/L.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Maricopa Medical Center
Phoenix, Arizona, 85008, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Loma Linda University Medical Center, Pediatric Dept., Div. of Critical Care - PICU
Loma Linda, California, 92354, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Pediatric Critical Care
Los Angeles, California, 90095, United States
Dept. of Anesthesia, SUMC
Stanford, California, 94305, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Joe Dimaggio Children's Hospital/Memorial Regional Hospital, Pediatric Intensive Care Unit
Hollywood, Florida, 33021, United States
Critical Care
Jacksonville, Florida, 32207, United States
University of Miami - Miller School of Medicine
Miami, Florida, 33136, United States
Miami Children's Hospital
Miami, Florida, 33155, United States
Unknown Facility
Orlando, Florida, 32806, United States
Pensacola Research Consultants, Inc.
Pensacola, Florida, 32504, United States
University of Chicago Comer Children's Hospital
Chicago, Illinois, 60637, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Advocate Lutheran General Children's Hospital
Park Ridge, Illinois, 60068, United States
Kosair Charities Pediatric Clinical Research Unit, University of Louisville
Louisville, Kentucky, 40202, United States
The John Hopkins Medical Institutions, Anesthesia and Critical Care Medicine
Baltimore, Maryland, 21287-8711, United States
F3900 C.S. Mott Hospital SPC 5211 Dept. of Anaesthesiology
Ann Arbor, Michigan, 48109-5211, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Gilette Children's Speciality Healthcare
Saint Paul, Minnesota, 55101, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University Medical Center, Department of Anesthesiology
Durham, North Carolina, 27710, United States
Akron Children's Hospital Medical Center
Akron, Ohio, 44308, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Northwest Pediatric Critical Care, P.C. Legacy Emanuel Children's Hospital
Portland, Oregon, 97227, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
University of Virginia, Division of Pediatric Critical Care
Charlottesville, Virginia, 22908, United States
Virginia Commonwealth University
Richmond, Virginia, 23298-0530, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Pediatric Intensive Care Unit, CHU Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marcelo Garcia de Rocha MD, Global Medical Director
- Organization
- Hospira
Study Officials
- STUDY DIRECTOR
Robert Bilkovski, MD
Medical Director, Hospira
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2009
First Posted
April 3, 2009
Study Start
January 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
August 14, 2015
Results First Posted
October 30, 2014
Record last verified: 2015-07