"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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 31, 2005
Last Updated Date	September 20, 2007
Start Date ^ICMJE	March 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: September 14, 2005)	The percentage of time spent within the protocol specified sedation range during the study drug administration period.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00216190 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 14, 2005)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	"A Safety and Efficacy Study of ICU Patients Requiring Continuous Sedation"
Official Title ^ICMJE	"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"
Brief Summary	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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Mechanically Ventilated and Intubated Subjects
Intervention ^ICMJE	Drug: Dexmedetomidine, Midazolam
Study Arm (s)	Not Provided
Publications *	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. Epub 2009 Feb 2.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	375
Completion Date	August 2007
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00216190
Other Study ID Numbers ^ICMJE	2001-001
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Hospira, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hospira, Inc.
Verification Date	September 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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