The Effect of Clonidine in Glycemia During Coronary Arter... | NCT01619436

Studies
The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass

NCT01619436

Sponsor

Federal University of Juiz de Fora

Status

Completed

Last Update Posted

Jun 14, 2012Estimated

Enrollment

46Actual

Phase

Phase 4

Conditions

Glycemia During Coronary Artery Bypass Graft
Sedation During Pre-anesthetic Medication

Interventions

Clonidine
Ringer lactato

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Jun 12, 2012

First Submission Date that Met QC Criteria

Jun 13, 2012

First Posted Date

Jun 14, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2012

Last Update Posted Date

Jun 14, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marcello F Salgado Filho, MD, Principal investigator, Federal University of Juiz de ForaPrincipal Investigator

Lead Sponsor

Federal University of Juiz de ForaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Clonidine	Drug	bolus, clonidine 2 mg/kg IV	clonidine
Ringer lactato

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sedation	Clonidine 2 mg/kg IV. assessment sedation with Ransay scale	2 years

Secondary Outcomes

Measure	Description	Time Frame
Glycemia	clonide 2 mg/kg. assessment the glycemia during CPB.	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective CABG EF > 40% Sinus ritmy

Exclusion Criteria:

precordialgia emergency surgery combinated surgery not agreement

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National institut of Cardiology		Rio de Janeiro	Rio de Janeiro	3600/100	Brazil

Label	URL
Related Info	View source
Related Info	View source
Related Info	View source

Intervention Browse Module

MeSH Terms

ID	Term
D003000	Clonidine

Ancestor Terms

ID	Term
D048288	Imidazolines
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

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Browse Branches

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