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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00216190




Registration number
NCT00216190
Ethics application status
Date submitted
31/08/2005
Date registered
22/09/2005
Date last updated
23/07/2015

Titles & IDs
Public title
A Safety and Efficacy Study of Dexmedetomidine in ICU Patients Requiring Continuous Sedation
Scientific 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
Secondary ID [1] 0 0
2001-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mechanically Ventilated and Intubated Subjects 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dexmedetomidine HCL Injection
Treatment: Drugs - Midazolam Injection

Experimental: Dexmedetomidine -

Active Comparator: Midazolam -


Treatment: Drugs: Dexmedetomidine HCL Injection


Treatment: Drugs: Midazolam Injection


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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])
Timepoint [1] 0 0
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 outcome [1] 0 0
Percentage of subjects able to achieve a RASS between - 2 and +1 without interruption of study drug
Timepoint [1] 0 0
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 outcome [2] 0 0
Percentage of subjects with evidence of delirium (Confusion Assessment Method [CAM]-ICU positive) while on study drug
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Percentage of subjects with evidence of delirium (CAM-ICU positive) following discontinuation of study drug
Timepoint [3] 0 0
At 12, 24, 36, and 48 hrs after end of infusion. Every 12 hours during the 48-hour Follow-Up Period.
Secondary outcome [4] 0 0
Time to achieving a RASS between -2 and +1 for daily arousal assessment
Timepoint [4] 0 0
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.
Secondary outcome [5] 0 0
Percentage of subjects who can interact with caregivers - Percentage of subjects who can interact with caregivers (i.e., follow at least 3 of the 4 arousal assessment commands) while in the protocol-specified RASS range of -2 to +1
Timepoint [5] 0 0
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.
Secondary outcome [6] 0 0
Overall drug (sedative) tolerance
Timepoint [6] 0 0
During the treatment period (Approximately 30 days)
Secondary outcome [7] 0 0
Fentanyl use
Timepoint [7] 0 0
During the treatment period (Approximately 30 days)
Secondary outcome [8] 0 0
Nursing assessment
Timepoint [8] 0 0
Screening period, during the treatment period (Approximately 30 days), and 48-hours of follow-up period
Secondary outcome [9] 0 0
Use of rescue midazolam for sedation
Timepoint [9] 0 0
During the treatment period (Approximately 30 days)

Eligibility
Key inclusion criteria
1. Subject is =18 years of age.

2. If female, subject is non-lactating, and is either:

1. Not of childbearing potential, defined as postmenopausal for at least 1 year or
surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or
hysterectomy.

2. 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.

3. 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.

4. 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.

5. Subject is sedated within a Richmond Agitation-Sedation Scale (RASS) range of -2 to +1
at the time of initiation of study drug
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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).

2. Subject has serious central nervous system pathology/trauma that, per clinical
judgment of the Investigator, precludes responsiveness or survival.

3. 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.

4. Subject for whom alpha-2 agonists are contraindicated.

5. Subject requires neuromuscular blocking agents during the study for use other than
intubation.

6. Subject requires epidural or spinal analgesia during the study.

7. Subject meets any of the following cardiovascular criteria:

- Acute unstable angina (defined during current hospital stay).

- Suspicion of acute myocardial infarction.

- Considered to have a left ventricular ejection fraction of less than 30%.
Decision to exclude is predicated on the Investigator's opinion, and may be based
on any combination of acute presentations, recently performed diagnostic studies,
or a history that suggests poor cardiac function. Pulmonary congestion of a
non-cardiac origin or mild congestive failure primarily attributable to
etiologies other than poor ventricular function are not exclusion criteria.

- 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.

8. 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.

9. 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.

10. Subject is unable to undergo any procedure required by the protocol.

11. Subject has laboratory results indicating the presence of liver disease consistent
with a Child-Pugh score >9 (Grade C).

12. Subject has acute hepatitis, history or presence of chronic hepatitis, and/or has had
a positive result for Hepatitis B Surface Antigen Test.

13. Subject requires dialysis (eg, hemodialysis, peritoneal dialysis, Continuous
Venovenous Hemodialysis [CVVHD]).

14. Subject has a known, uncontrolled seizure disorder.

15. Subject has, per the Investigator's judgment, a known or suspected physical or
psychological dependence on an abused drug, other than alcohol.

16. Subject has a known psychiatric illness that could confound a normal response to
sedative treatment.

17. Subject is incarcerated.

18. Subject is terminally ill with a life duration expectancy of =60 days.

19. Subject has any other condition or factor which, in the Investigator's opinion, might
increase the risk to the subject.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Blacktown
Recruitment hospital [2] 0 0
- Randwick
Recruitment hospital [3] 0 0
- Woodville
Recruitment hospital [4] 0 0
- Hobart
Recruitment hospital [5] 0 0
- Box Hill
Recruitment hospital [6] 0 0
- Heidelberg
Recruitment hospital [7] 0 0
- Parkville
Recruitment hospital [8] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
5011 - Woodville
Recruitment postcode(s) [4] 0 0
7001 - Hobart
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Iowa
Country [14] 0 0
United States of America
State/province [14] 0 0
Kansas
Country [15] 0 0
United States of America
State/province [15] 0 0
Kentucky
Country [16] 0 0
United States of America
State/province [16] 0 0
Louisiana
Country [17] 0 0
United States of America
State/province [17] 0 0
Maine
Country [18] 0 0
United States of America
State/province [18] 0 0
Maryland
Country [19] 0 0
United States of America
State/province [19] 0 0
Massachusetts
Country [20] 0 0
United States of America
State/province [20] 0 0
Michigan
Country [21] 0 0
United States of America
State/province [21] 0 0
Montana
Country [22] 0 0
United States of America
State/province [22] 0 0
Nebraska
Country [23] 0 0
United States of America
State/province [23] 0 0
New Jersey
Country [24] 0 0
United States of America
State/province [24] 0 0
New York
Country [25] 0 0
United States of America
State/province [25] 0 0
North Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Oklahoma
Country [28] 0 0
United States of America
State/province [28] 0 0
Oregon
Country [29] 0 0
United States of America
State/province [29] 0 0
Pennsylvania
Country [30] 0 0
United States of America
State/province [30] 0 0
South Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
Tennessee
Country [32] 0 0
United States of America
State/province [32] 0 0
Texas
Country [33] 0 0
United States of America
State/province [33] 0 0
Utah
Country [34] 0 0
United States of America
State/province [34] 0 0
Virginia
Country [35] 0 0
United States of America
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West Virginia
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United States of America
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Wisconsin
Country [37] 0 0
Argentina
State/province [37] 0 0
Ciudad de Buenos Aires
Country [38] 0 0
Brazil
State/province [38] 0 0
RS
Country [39] 0 0
Brazil
State/province [39] 0 0
San Paulo
Country [40] 0 0
Brazil
State/province [40] 0 0
SP
Country [41] 0 0
New Zealand
State/province [41] 0 0
Christchurch
Country [42] 0 0
New Zealand
State/province [42] 0 0
Hastings
Country [43] 0 0
New Zealand
State/province [43] 0 0
Palmerston North
Country [44] 0 0
New Zealand
State/province [44] 0 0
Welling

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hospira, now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00216190
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications