"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

August 31, 2005
September 20, 2007
March 2005
Not Provided
The percentage of time spent within the protocol specified sedation range during the study drug administration period.
Same as current
Complete list of historical versions of study NCT00216190 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
"A Safety and Efficacy Study of ICU Patients Requiring Continuous Sedation"
"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"

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.

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.

Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Mechanically Ventilated and Intubated Subjects
Drug: Dexmedetomidine, Midazolam
Not Provided
Riker RR, Shehabi Y, Bokesch PM, Ceraso D, Wisemandle W, Koura F, Whitten P, Margolis BD, Byrne DW, Ely EW, Rocha MG; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009 Feb 4;301(5):489-99. doi: 10.1001/jama.2009.56. Epub 2009 Feb 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2007
Not Provided

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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Hospira, Inc.
Not Provided
Not Provided
Hospira, Inc.
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP