NCT01619436

Brief Summary

The purpose of this study is the randomized blind research of the assessment of the different levels of glycemia during Coronary Artery Bypass Graft (CABG) with cardiopulmonary by-pass (CPB) between clonidine and placebo. As clonidine decrease the inflammatory response during cardiac surgery, the investigators would like to know if the glycemia levels in clondine group will be lower than placebo group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

June 12, 2012

Last Update Submit

June 13, 2012

Conditions

Glycemia During Coronary Artery Bypass GraftSedation During Pre-anesthetic Medication

Outcome Measures

Primary Outcomes (1)

  • sedation

    Clonidine 2 mg/kg IV. assessment sedation with Ransay scale

    2 years

Secondary Outcomes (1)

  • Glycemia

    2 years

Study Arms (2)

clonidine

ACTIVE COMPARATOR

clonidine 2 mg/kg IV

Drug: Clonidine

ringer lactato 1 ml

PLACEBO COMPARATOR

Ringer lactato 1 ml IV as Placebo

Drug: Ringer lactato

Interventions

ClonidineDRUG

bolus, clonidine 2 mg/kg IV

clonidine
Ringer lactatoDRUG

1 ML ringer lactato IV, as placebo

ringer lactato 1 ml

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective CABG EF \> 40% Sinus ritmy

You may not qualify if:

  • precordialgia emergency surgery combinated surgery not agreement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National institut of Cardiology

Rio de Janeiro, Rio de Janeiro, 3600/100, Brazil

Location

Related Links

MeSH Terms

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 14, 2012

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

May 1, 2012

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

BR(1)