NCT01256866

Brief Summary

The aim of this prospective randomized study is to compare the safety and efficacy of two strategies for sedation of critically ill patients submitted to mechanical ventilation: continuous intravenous infusion of dexmedetomidine versus intravenous bolus of midazolam. The two groups will be compared as to the incidence of of delirium, evaluated with the Confusion Assessment Method for ICU (CAM-ICU) and the percentage of time within the target sedation using the Richmond Agitation-Sedation Scale (RAAS).Eligible patients will be 18 years or older intubated and mechanically ventilated for less than 48 hours prior to start of study drug and anticipated ventilation duration of at least 48 hours. Calculated sample size is 146 patients (73 patients in each group)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 9, 2010

Status Verified

November 1, 2010

Enrollment Period

11 months

First QC Date

December 8, 2010

Last Update Submit

December 8, 2010

Conditions

Mechanically Ventilated PatientsSedationDexmedetomidineMidazolam

Keywords

DexmedetomidineMidazolamSedationMechanical ventilationCritically ill patients

Outcome Measures

Primary Outcomes (1)

  • Incidence of delirium

Secondary Outcomes (1)

  • PERCENTAGE OF TIME WITHIN THE TARGET SEDATION

Study Arms (2)

DEXMEDETOMIDINE, SEDATION

ACTIVE COMPARATOR
Drug: Dexmedetomidine

Midazolam, sedation,

ACTIVE COMPARATOR
Drug: Midazolam

Interventions

DexmedetomidineDRUG
DEXMEDETOMIDINE, SEDATION
MidazolamDRUG
Midazolam, sedation,

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult mechanically ventilated, critically ill patients

You may not qualify if:

  • pregnancy or lactation, severe liver disease, hearth rate less than 50, hypotension despite volemic repletion and vasoactive drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sao Domingos

São Luís, Maranhão, 65060-100, Brazil

RECRUITING

MeSH Terms

Interventions

DexmedetomidineMidazolam

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 8, 2010

First Posted

December 9, 2010

Study Start

November 1, 2010

Primary Completion

October 1, 2011

Study Completion

June 1, 2012

Last Updated

December 9, 2010

Record last verified: 2010-11

Locations

BR(1)