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

Tracking Information
First Submitted Date ICMJE	June 12, 2012
First Posted Date ICMJE	June 14, 2012
Last Update Posted Date	June 14, 2012
Study Start Date ICMJE	January 2011
Actual 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 ]; Clonidine 2 mg/kg IV. assessment sedation with Ransay scale
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: June 13, 2012)	Glycemia [ Time Frame: 2 years ]; 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; Intervention Model: Parallel Assignment; Masking: Single (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 Arms	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
Actual Enrollment ICMJE; (submitted: June 13, 2012)	46
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	May 2012
Actual 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
Sex/Gender	Sexes Eligible for Study: All
Ages	45 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Brazil
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01619436
Other Study ID Numbers ICMJE	0279/03.05.2010
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
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
PRS Account	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