"A Safety and Efficacy Study of ICU Patients Requiring Continuous Sedation" - Full Text View

Sponsor:	Hospira, Inc.
Information provided by:	Hospira, Inc.
ClinicalTrials.gov Identifier:	NCT00216190

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:

Drug Information available for: Midazolam hydrochloride Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

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

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):

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.

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
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
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 May 24, 2012