"A Safety and Efficacy Study of ICU Patients Requiring Continuous Sedation"

This study has been completed.
Information provided by:
Hospira, Inc.
ClinicalTrials.gov Identifier:
First received: August 31, 2005
Last updated: September 20, 2007
Last verified: September 2007

The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU subjects that are initially intubated, mechanically ventilated and require sedation for greater tha 24 hours.

Condition Intervention Phase
Mechanically Ventilated and Intubated Subjects
Drug: Dexmedetomidine, Midazolam
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: "A Phase 4, Randomized, Double-Blind, Multi-Center, Comparator Study Evaluating the Safety and Efficacy of Dexmedetomidine Compared to IV Midazolam in ICU Subjects Requiring Greater Than Twenty-Four Hours of Continuous Sedation"

Resource links provided by NLM:

Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • The percentage of time spent within the protocol specified sedation range during the study drug administration period.

Secondary Outcome Measures:
  • Number of subjects able to maintain a specified sedation range without study drug interruption; the amount of time required to regain the specified level of sedation; number of subjects displaying delirium characteristics.

Estimated Enrollment: 375
Study Start Date: March 2005
Study Completion Date: August 2007
Detailed Description:

Traditional agents such benzodiazepines and propofol have long been used to sedate critically ill patients. Unfortunately, these agents have serious disadvantages that may have a negative impact on patient outcomes. These disadvantages include respiratory depression, prolonged mechanical ventilation, paradoxical agitation, myocardial depression, hypotension, tachyphylaxis, physical dependence, and an unpredictable duration of action following long term infusions. Additionally, concomitant use of an opioid or other analgesic is often required for ICU patients to achieve adequate levels of pain relief, which may also prolong awakening and possibly increase respiratory depression.

Dexmedetomidine may offer a new treatment option that remedies many of the deficiencies of traditional sedatives. This agent would provide for accurate, titratable sedation and analgesia without the concurrent respiratory depression and accumulation common to other agents. It may permit greater patient interaction due to reduced impairment of cognition and may reduce risks associated with opioids due to its analgesia sparing property. Although such a drug may have important benefits for ICU patients requiring sedation for greater than 24 hours, dexmedetomidine is not currently approved for such long-term usage.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject is initially intubated, mechanically ventilated, and is anticipated to require continuous sedation for at least 72 hours
  • Subject is sedated within a protocol specified range at the time of study drug administration

Exclusion Criteria:

  • Subject has been intubated for greater than 96 hours prior to the initiation of study drug
  • Subject has serious central nervous system pathology/trauma
  • Subject for whom opiates, benzodiazepines, or dexmedetomidine are contraindicated or who has known or suspected serious allergy to any drug that might be administered during the course of the study
  • Subject has a history or current evidence of cardiovascular disease
  • Subject has participated in a trial with any experimental drug within 30 days prior to enrollment in the study or has ever been enrolled in this study
  • Subject has laboratory results indicating the presence of liver disease consistent with a Child Pugh Score > 9 (Grade C)
  • Subject has acute hepatitis, history or presence of chronic hepatitis, and/or has had a positive result for Hepatitis B Surface Antigen Test.
  • Subject requires dialysis
  • Subject is terminally ill with a life duration expectancy of <60 days
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00216190

  Show 77 Study Locations
Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided by Hospira, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00216190     History of Changes
Other Study ID Numbers: 2001-001
Study First Received: August 31, 2005
Last Updated: September 20, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Hospira, Inc.:
Sedation, ICU, Anesthesia, Dexmedetomidine, Midazolam

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics, Non-Narcotic
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on July 01, 2015