Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Adjunct Dexmedetomidine (Precedex®) Therapy Impact on Sedative and Analgesic Requirement

This study has been withdrawn prior to enrollment.
(PI resigned.)
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT00852046
First received: February 24, 2009
Last updated: October 5, 2011
Last verified: July 2011

February 24, 2009
October 5, 2011
February 2009
March 2009   (final data collection date for primary outcome measure)
Total daily dose of fentanyl and propofol [ Time Frame: Daily ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00852046 on ClinicalTrials.gov Archive Site
  • Total ventilation time [ Time Frame: Study ended ] [ Designated as safety issue: No ]
  • ICU length of stay [ Time Frame: Study ended. ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: Study ended ] [ Designated as safety issue: No ]
  • Patient outcomes/mortality [ Time Frame: Study ended. ] [ Designated as safety issue: Yes ]
  • Total pharmacy expenditures [ Time Frame: Study ended. ] [ Designated as safety issue: No ]
  • Total ventilation time [ Designated as safety issue: No ]
  • ICU length of stay [ Designated as safety issue: No ]
  • Hospital length of stay [ Designated as safety issue: No ]
  • Patient outcomes/mortality [ Designated as safety issue: Yes ]
  • Total pharmacy expenditures [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Adjunct Dexmedetomidine (Precedex®) Therapy Impact on Sedative and Analgesic Requirement
Adjunct Dexmedetomidine Therapy Impact on Sedative and Analgesic

Assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.

Patients identified by selection criteria within 48 hours of intubation will be randomly assigned to one of three study arms: dexmedetomidine 0.2 mcg/kg/hr, dexmedetomidine 0.6 mcg/kg/hr, or placebo. If not already on, patients will be converted to propofol and fentanyl for sedation and analgesia, which will be titrated to a goal SAS score of 3-4.

Patients will be monitored, assessed, and evaluated by all regular policies and procedures of the institution. Extubation will be at the discretion of the physicians and medical team caring for the patient. If the patient is still intubated at five days study drug will then be stopped and further use of dexmedetomidine will be at the discretion of the physicians.

Primary objective will assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.

Secondary objectives include total ventilation time, ICU length of stay, hospital length of stay, patient outcomes/mortality, and total pharmacy expenditures.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Sedation
  • Analgesia
Drug: Dexmedetomidine
IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days
Other Name: Precedex
  • Experimental: 1. Low dose dexmedetomidine
    Dexmedetomidine 0.2 mcg/kg/hr added to fentanyl & propofol.
    Intervention: Drug: Dexmedetomidine
  • Experimental: 2. High dose dexmedetomidine
    Dexmedetomidine 0.6 mcg/kg/hr added to fentanyl & propofol.
    Intervention: Drug: Dexmedetomidine
  • Placebo Comparator: 3. Placebo
    Placebo added to fentanyl & propofol.
    Intervention: Drug: Dexmedetomidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • surgical, medical, or trauma patients requiring sedation for mechanical ventilation
  • age 18-80
  • Anticipated ventilation time of > 24 hrs
  • Reasonable chance of recovery

Exclusion Criteria:

  • Severe COPD
  • Chronic immunosuppression (equivalent to prednisone 7.5 mg daily or higher)
  • Heart block
  • Bradycardia
  • Significant head injury
  • Goal SAS score of 1-2
  • Severe hepatic impairment
  • Hypertriglyceridemia
  • Allergy to dexmedetomidine, fentanyl, propofol or eggs
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00852046
#2008.071
Yes
Avera McKennan Hospital & University Health Center
Avera McKennan Hospital & University Health Center
Not Provided
Principal Investigator: John A Kappes, Pharm.D. Avera McKennan Hospital
Avera McKennan Hospital & University Health Center
July 2011

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