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This study has been withdrawn prior to enrollment.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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 24, 2009

Last Updated Date

October 5, 2011

Start Date ^ICMJE

February 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Total daily dose of fentanyl and propofol [ Time Frame: Daily ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00852046 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Adjunct Dexmedetomidine Therapy Impact on Sedative and Analgesic

Brief Summary

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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Sedation
Analgesia

Intervention ^ICMJE

Drug: Dexmedetomidine

IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days

Other Name: Precedex

Study Arm (s)

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

Publications *

Not Provided

* 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

Withdrawn

Enrollment ^ICMJE

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00852046

Other Study ID Numbers ^ICMJE

#2008.071

Has Data Monitoring Committee

Yes

Responsible Party

Avera McKennan Hospital & University Health Center

Study Sponsor ^ICMJE

Avera McKennan Hospital & University Health Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

John A Kappes, Pharm.D.

Avera McKennan Hospital

Information Provided By

Avera McKennan Hospital & University Health Center

Verification Date

July 2011

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

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