NCT00852046

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

October 6, 2011

Status Verified

July 1, 2011

Enrollment Period

28 days

First QC Date

February 24, 2009

Last Update Submit

October 5, 2011

Conditions

SedationAnalgesia

Keywords

Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Total daily dose of fentanyl and propofol

    Daily

Secondary Outcomes (5)

  • Total ventilation time

    Study ended

  • ICU length of stay

    Study ended.

  • Hospital length of stay

    Study ended

  • Patient outcomes/mortality

    Study ended.

  • Total pharmacy expenditures

    Study ended.

Study Arms (3)

1. Low dose dexmedetomidine

EXPERIMENTAL

Dexmedetomidine 0.2 mcg/kg/hr added to fentanyl \& propofol.

Drug: Dexmedetomidine

2. High dose dexmedetomidine

EXPERIMENTAL

Dexmedetomidine 0.6 mcg/kg/hr added to fentanyl \& propofol.

Drug: Dexmedetomidine

3. Placebo

PLACEBO COMPARATOR

Placebo added to fentanyl \& propofol.

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

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

Also known as: Precedex
1. Low dose dexmedetomidine2. High dose dexmedetomidine3. Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • John A Kappes, Pharm.D.

    Avera McKennan Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2009

First Posted

February 26, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

October 6, 2011

Record last verified: 2011-07