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

This study has been completed.
Sponsor:
Information provided by:
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT00216190
First received: August 31, 2005
Last updated: September 20, 2007
Last verified: September 2007
  Purpose

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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216190

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Chandler, Arizona, United States, 85248
Phoenix, Arizona, United States
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Rogers, Arkansas, United States, 72758
United States, California
Davis, California, United States, 95616
Laguna Hills, California, United States
Loma Linda, California, United States, 92354
Palo Alto, California, United States, 94304
Pasadena, California, United States, 91109
Redlands, California, United States, 92373
Sacramento, California, United States, 95819
San Francisco, California, United States, 94143
San Jose, California, United States
United States, Colorado
Denver, Colorado, United States, 80204
United States, Connecticut
Farmington, Connecticut, United States, 06030
New Haven, Connecticut, United States, 06520
United States, Delaware
Newark, Delaware, United States, 19718
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Bay Pines, Florida, United States, 33744
Miami, Florida, United States
Orlando, Florida, United States, 32804
Tampa, Florida, United States, 33612
United States, Georgia
Atlanta, Georgia, United States
Augusta, Georgia, United States, 30909
Gordon, Georgia, United States, 30905
United States, Illinois
Arlington Heights, Illinois, United States, 60005
Oak Park, Illinois, United States
Peoria, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas City, Kansas, United States, 66160
Olathe, Kansas, United States
United States, Kentucky
Hazard, Kentucky, United States, 41701
Louisville, Kentucky, United States, 40206
United States, Louisiana
Alexandria, Louisiana, United States, 71301
Shreveport, Louisiana, United States
United States, Maine
Auburn, Maine, United States, 04210
Biddeford, Maine, United States, 04005
Portland, Maine, United States
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Michigan
Flint, Michigan, United States, 48532
United States, Montana
Missoula, Montana, United States
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, New Jersey
Camden, New Jersey, United States, 08103
Englewood, New Jersey, United States, 07631
United States, New York
Bronx, New York, United States
Brooklyn, New York, United States, 11215
Buffalo, New York, United States, 14215
Long Island, New York, United States
New York, New York, United States, 10011
Rochester, New York, United States, 14642
Stoney Brook, New York, United States, 11794
Syracuse, New York, United States, 13210
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
Charlotte, North Carolina, United States, 28207
Greensboro, North Carolina, United States
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Akron, Ohio, United States, 44307
Kettering, Ohio, United States, 45429
Toledo, Ohio, United States, 43608
United States, Oklahoma
Olkahoma City, Oklahoma, United States, 73104
United States, Oregon
Medford, Oregon, United States, 97504
United States, Pennsylvania
Danville, Pennsylvania, United States, 17882
Monroeville, Pennsylvania, United States, 15146
Pittsburgh, Pennsylvania, United States, 15219
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Dallas, Texas, United States
Dallas, Texas, United States, 75246
Galveston, Texas, United States, 77555
Houston, Texas, United States, 77024
Lubbock, Texas, United States, 79430
United States, Utah
Ogden, Utah, United States, 84403
United States, Virginia
Lynchburg, Virginia, United States, 24501
United States, West Virginia
Morgantown, West Virginia, United States, 26505
United States, Wisconsin
Madison, Wisconsin, United States, 53792
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:
Midazolam
Dexmedetomidine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on September 18, 2014