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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Marcello F Salgado Filho, MD, Federal University of Juiz de Fora

ClinicalTrials.gov Identifier:

NCT01619436

First received: June 12, 2012

Last updated: June 13, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 12, 2012
Last Updated Date	June 13, 2012
Start Date ^ICMJE	January 2011
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 13, 2012)	sedation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] Clonidine 2 mg/kg IV. assessment sedation with Ransay scale
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01619436 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 13, 2012)	Glycemia [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] clonide 2 mg/kg. assessment the glycemia during CPB.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass
Official Title ^ICMJE	The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass.
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
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Glycemia During Coronary Artery Bypass Graft Sedation During Pre-anesthetic Medication
Intervention ^ICMJE	Drug: Clonidine bolus, clonidine 2 mg/kg IV Drug: Ringer lactato 1 ML ringer lactato IV, as placebo
Study Arm (s)	Active Comparator: clonidine clonidine 2 mg/kg IV Intervention: Drug: Clonidine Placebo Comparator: ringer lactato 1 ml Ringer lactato 1 ml IV as Placebo Intervention: Drug: Ringer lactato
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	Completed
Enrollment ^ICMJE	46
Completion Date	May 2012
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: elective CABG EF > 40% Sinus ritmy Exclusion Criteria: precordialgia emergency surgery combinated surgery not agreement
Gender	Both
Ages	45 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT01619436
Other Study ID Numbers ^ICMJE	0279/03.05.2010
Has Data Monitoring Committee	Yes
Responsible Party	Marcello F Salgado Filho, MD, Federal University of Juiz de Fora
Study Sponsor ^ICMJE	Federal University of Juiz de Fora
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Federal University of Juiz de Fora
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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