A Safety and Efficacy Study of Dexmedetomidine in ICU Patients Requiring Continuous Sedation

NCT00216190 | Completed Phase 4

• 1 other identifier: 2001-001
• Study Type: interventional
• Target: 420
• Locations: 5 countries
• Sites: 96

Brief Summary

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

Conditions

Mechanically Ventilated and Intubated Subjects

Keywords

Sedation, ICU, Anesthesia, Dexmedetomidine, Midazolam

Outcome Measures

Primary Outcomes (1)

• The percentage of time spent within the protocol specified sedation range (Richmond Agitation-Sedation Scale [RASS] range of -2 to +1)

  RASS Range: Score +1 (Restless: Anxious; but movements not aggressive or vigorous) Score 0 (Alert and calm) Score -1 (Drowsy: Not fully alert, but has sustained awakening \[eye opening/eye contact\] to voice \[≥10 seconds\]) Score -2 (Light sedation: Briefly awakens with eye contact to voice \[\< 10 seconds\])

  Preinfusion, Treatment period: every 10min for 30min, 1 & 4 hr after infusion starts, every 4 hrs, prior to end of infusion & extubation. Follow-up Period (48hrs): every 10min for 1st 30min after drug discontinuation, 1, 4, 8,12, 24 & 48 hr post infusion

Secondary Outcomes (9)

• Percentage of subjects able to achieve a RASS between - 2 and +1 without interruption of study drug

  Preinfusion, Treatment period: every 10min for 30min, 1 & 4 hr after infusion starts, every 4 hrs, prior to end of infusion & extubation. Follow-up Period (48hrs): every 10min for 1st 30min after drug discontinuation, 1, 4, 8,12, 24 & 48 hr post infusion

• Percentage of subjects with evidence of delirium (Confusion Assessment Method [CAM]-ICU positive) while on study drug

  Prior to the start of the study drug infusion. Daily each morning beginning the day after starting study drug, and at the end of study drug infusion.

• Percentage of subjects with evidence of delirium (CAM-ICU positive) following discontinuation of study drug

  At 12, 24, 36, and 48 hrs after end of infusion. Every 12 hours during the 48-hour Follow-Up Period.

• Time to achieving a RASS between -2 and +1 for daily arousal assessment

  Prior to the start of the study drug infusion. Daily each morning beginning the day after starting study drug, and at the end of study drug infusion.

• Percentage of subjects who can interact with caregivers

  Prior to start of infusion (Day 0), daily each morning throughout the Treatment Period beginning on the day after randomization (Study Day 1), and immediately prior to discontinuation of study drug infusion at the end of Treatment Period.

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine HCL Injection

Midazolam

ACTIVE COMPARATOR

Drug: Midazolam Injection

Interventions

Dexmedetomidine HCL Injection DRUG

Dexmedetomidine

Midazolam Injection DRUG

Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥18 years of age.
• If female, subject is non-lactating, and is either:
• Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.
• Of childbearing potential but is not pregnant as confirmed by negative serum pregnancy test at time of screening, and is practicing one of the following methods of birth control: oral or parenteral contraceptives for three months prior to study drug administration, a vasectomized partner, or abstinence from sexual intercourse.
• Subject is initially intubated and mechanically ventilated, or is planned for imminent intubation and mechanical ventilation, sedation is anticipated to be required during mechanical ventilation, and mechanical ventilation is anticipated to continue for at least 72 hours.
• Subject or subject's legally authorized representative has voluntarily signed and dated an informed consent form, approved by the applicable Institutional Review Board (IRB), after the nature of the study has been explained and the subject or subject's legally authorized representative has had the opportunity to ask questions. The informed consent must be signed before any study specific procedures are performed.
• Subject is sedated within a Richmond Agitation-Sedation Scale (RASS) range of -2 to +1 at the time of initiation of study drug

You may not qualify if:

• Subject has been intubated for greater than 96 hours prior to the initiation of study drug (thus, the attainment of consent, screening evaluations, and randomization must all have been completed by the 96th hour post-intubation, so that the actual initiation of the study drug infusion may start by the end of the 96 hour window).
• Subject has serious central nervous system pathology/trauma that, per clinical judgment of the Investigator, precludes responsiveness or survival.
• 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 for whom alpha-2 agonists are contraindicated.
• Subject requires neuromuscular blocking agents during the study for use other than intubation.
• Subject requires epidural or spinal analgesia during the study.
• Subject meets any of the following cardiovascular criteria:
• Acute unstable angina (defined during current hospital stay).
• Suspicion of acute myocardial infarction.
• Heart rate \<50 bpm prior to infusion start.
• Systolic blood pressure \<90 mmHg prior to infusion start.
• Conduction abnormalities except 1st degree AV block and rate-controlled atrial fibrillation; subjects with functional pacemaker capacity may be enrolled.
• Subject is hospitalized primarily due to trauma and/or burns, has received general anaesthesia within the 24 hours prior to the start of study drug infusion, or is anticipated to require general anaesthesia within 24 hours after the start of the infusion.
• 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 is unable to undergo any procedure required by the protocol.

Sponsors & Collaborators

• Hospira, now a wholly owned subsidiary of Pfizer: lead

Study Sites (96)

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Birmingham, Alabama, 35294, United States

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Chandler, Arizona, 85248, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, 85258, United States

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Rogers, Arkansas, 72756, United States

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Davis, California, 95616, United States

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Loma Linda, California, 92354, United States

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Palo Alto, California, 94304, United States

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Pasadena, California, 91105, United States

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Redlands, California, 92373, United States

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Sacramento, California, 95819, United States

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San Clemente, California, 92672, United States

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San Francisco, California, United States

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San Jose, California, United States

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Denver, Colorado, 80204, United States

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Farmington, Connecticut, 06030, United States

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New Haven, Connecticut, 06520, United States

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Newark, Delaware, 19718, United States

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Washington D.C., District of Columbia, 20010, United States

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Bay Pines, Florida, 33744, United States

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Miami, Florida, United States

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Orlando, Florida, 32804, United States

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Tampa, Florida, 33606, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, 30909, United States

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Gordon, Georgia, 30905, United States

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Arlington Heights, Illinois, 60005, United States

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Oak Park, Illinois, 60302, United States

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Peoria, Illinois, 61603, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, 52242, United States

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Kansas City, Kansas, 66160, United States

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Olathe, Kansas, 66061, United States

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Hazard, Kentucky, 41701, United States

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Louisville, Kentucky, United States

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Alexandria, Louisiana, 71301, United States

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Shreveport, Louisiana, United States

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Biddeford, Maine, 04005, United States

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Portland, Maine, United States

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Baltimore, Maryland, 21201, United States

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Boston, Massachusetts, 02115, United States

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Flint, Michigan, 48532, United States

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Missoula, Montana, United States

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Omaha, Nebraska, 68131, United States

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Camden, New Jersey, 08103, United States

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Englewood, New Jersey, 07631, United States

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Brooklyn, New York, 11215, United States

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Buffalo, New York, 14215, United States

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Mineola, New York, 11501, United States

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New York, New York, 10011, United States

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Rochester, New York, 14642, United States

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Stoney Brook, New York, 11794, United States

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Syracuse, New York, 13210, United States

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The Bronx, New York, United States

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Chapel Hill, North Carolina, 27599, United States

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Charlotte, North Carolina, 28207, United States

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Greensboro, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, 44307, United States

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Dayton, Ohio, 45429, United States

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Kettering, Ohio, 45429, United States

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Toledo, Ohio, United States

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Olkahoma City, Oklahoma, 73104, United States

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Medford, Oregon, 97504, United States

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Danville, Pennsylvania, 17882, United States

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Monroeville, Pennsylvania, 15146, United States

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Pittsburgh, Pennsylvania, 15219, United States

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Charleston, South Carolina, 29425, United States

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Spartanburg, South Carolina, 29303, United States

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Memphis, Tennessee, 38163, United States

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Dallas, Texas, United States

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Galveston, Texas, 77555, United States

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Houston, Texas, 77024, United States

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Lubbock, Texas, 79430, United States

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Ogden, Utah, 84403, United States

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Lynchburg, Virginia, 24501, United States

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Morgantown, West Virginia, 26505, United States

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Madison, Wisconsin, 53792, United States

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Ciudad de Buenos Aires, Argentina

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Blacktown, New South Wales, 2148, Australia

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Randwick, New South Wales, 2031, Australia

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Woodville, South Australia, 5011, Australia

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Hobart, Tasmania, 7001, Australia

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Box Hill, Victoria, 3128, Australia

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Heidelberg, Victoria, 3084, Australia

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Parkville, Victoria, 3050, Australia

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Perth, Western Australia, 6000, Australia

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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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Pedro de Toledo, São Paulo, 04039-901, Brazil

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Santo André, São Paulo, 09190-610, Brazil

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São Paulo, São Paulo, 01323-001, Brazil

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Christchurch, 8001, New Zealand

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Hastings, 4201, New Zealand

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Palmerston North, 5301, New Zealand

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Welling, 6002, New Zealand

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Related Publications (1)

• 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.

  PMID: 19188334 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 22, 2005
• Study Start: March 1, 2005
• Study Completion: August 1, 2007
• Last Updated: July 23, 2015

Record last verified: 2015-07

Locations

US (78); AR (1); BR (5); NZ (4); AU (8)