Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects - Full Text View

Sponsored by:	Hospira, Inc.
Information provided by:	Hospira, Inc.
ClinicalTrials.gov Identifier:	NCT00875550

Purpose

An estimated 175 subjects will be enrolled at approximately 40 investigative sites. Subjects will be divided into two treatment groups to receive either high dose or low dose DEX. The loading and maintenance doses in both groups will be stratified according to the presence or absence of cardiopulmonary bypass. The level of sedation will be assessed using the University of Michigan Sedation Scale (UMSS). Based on these scores and clinical judgment, additional sedation with intravenous midazolam will be administered according to the label. The UMSS scores must be documented before the administration of every MDZ dose and within five minutes after each dose of MDZ. Fentanyl or morphine may be administered to treat pain. Subjects may be extubated after beginning of study drug but are not required to be as part of the study.

The efficacy and safety parameters that will be monitored include sedation levels, heart rate, blood pressure and ventilation indicators. Once subjects have met site-specified respiratory criteria, they will undergo tracheal extubation. The dexmedetomidine infusion may be continued during and after extubation if further sedation is required post-extubation. The continuous infusion of dexmedetomidine may be administered for a minimum of 6 hours and a maximum of one week. Sedation levels, heart rate, blood pressure, respiratory rate, transcutaneous CO2 or arterial blood gases (if available) and oxygen saturation will be monitored and recorded in the peri-extubation period.

Condition	Intervention	Phase
Sedation	Drug: Dexmedetomidine Drug: Midazolam Drug: Fentanyl Drug: Morphine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Midazolam Dexmedetomidine Dexmedetomidine hydrochloride Fentanyl

U.S. FDA Resources

Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:

The percent of subjects that do not require rescue midazolam for sedation based on achieving and maintaining a target UMSS score of 1-3 while intubated. [ Time Frame: 6 hours up to 1 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment:

175

Arms	Assigned Interventions
Dexmedetomidine Low Dose: Active Comparator	Drug: Dexmedetomidine Study drug titrated up or down to maintain target UMSS range. Drug: Midazolam Rescue medication for sedation according to UMSS scores Drug: Fentanyl Rescue medication for pain based on UMSS scores Drug: Morphine Rescue medication for pain based on UMSS scores.
Dexmedetomidine High dose: Active Comparator	Drug: Dexmedetomidine Study drug titrated up or down to maintain target UMSS range. Drug: Midazolam Rescue medication for sedation according to UMSS scores Drug: Fentanyl Rescue medication for pain based on UMSS scores Drug: Morphine Rescue medication for pain based on UMSS scores.

Eligibility

Ages Eligible for Study:	1 Month to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting.
Anticipated to require a minimum of 6 hours of continuous intravenous sedation.
ASA classification of 1, 2, 3, or 4.
Age range > 1 month to < 17 years old.
If female, subject is non-lactating and is either not of childbearing potential,or 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.

Exclusion Criteria:

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).
Age > 17 years.
Subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires.
Hypotension based on repeat assessments prior to starting study drug
Pre-existing bradycardia prior to starting study drugs
SGPT (ALT): 1 month - 12 months: > 165 U/L; > 12 months - 17 years: > 100 U/L.
Subjects who have a known allergy to dexmedetomidine, MDZ, morphine or fentanyl.
Requirement for medications other than DEX, midazolam, morphine or fentanyl for sedation and pain control.
Subjects with paralysis from continuous infusion of neuromuscular blocking agents or a spinal cord injury above T5.
Subjects who have received another investigational drug within the past 30 days.
Subjects who, in the opinion of the investigator, have any other condition where the risks of DEX would be expected to outweigh its benefits (e.g. cardiogenic shock on > 2 vasopressors).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875550

Contacts

Contact: Paula Bokesch, MD

paula.bokesch@hospira.com

Locations

United States, New York
Women's and Children's Hospital of Buffalo
Buffalo, New York, United States

Sponsors and Collaborators

Hospira, Inc.

More Information

No publications provided

Responsible Party:	Hospira, Inc. ( Paulla Bokesch, MD )
Study ID Numbers:	DEX-08-05
Study First Received:	March 31, 2009
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00875550 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hospira, Inc.:

Intubated and mechanically ventilated PICU subjects

Study placed in the following topic categories:

Morphine
Neurotransmitter Agents
Fentanyl
Adrenergic alpha-Agonists
Adrenergic Agents
Benzocaine
Central Nervous System Depressants

Midazolam
Adrenergic Agonists
Analgesics, Non-Narcotic
Hypnotics and Sedatives
Dexmedetomidine
Analgesics
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Pharmacologic Actions
Adrenergic Agonists

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Dexmedetomidine
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009