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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
  Purpose

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.


Condition Intervention Phase
Glycemia During Coronary Artery Bypass Graft
Sedation During Pre-anesthetic Medication
 Drug: Clonidine
Drug: Ringer lactato
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of Juiz de Fora:

Primary Outcome Measures:
  • sedation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Clonidine 2 mg/kg IV. assessment sedation with Ransay scale


Secondary Outcome Measures:
  • Glycemia [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    clonide 2 mg/kg. assessment the glycemia during CPB.


Enrollment: 46
Study Start Date: January 2011
Study Completion Date: May 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: clonidine
clonidine 2 mg/kg IV
 Drug: Clonidine
bolus, clonidine 2 mg/kg IV
Placebo Comparator: ringer lactato 1 ml
Ringer lactato 1 ml IV as Placebo
 Drug: Ringer lactato
1 ML ringer lactato IV, as placebo

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective CABG EF > 40% Sinus ritmy

Exclusion Criteria:

  • precordialgia emergency surgery combinated surgery not agreement
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619436

Locations
Brazil
National institut of Cardiology
Rio de Janeiro, RJ, Brazil, 3600/100
Sponsors and Collaborators
Federal University of Juiz de Fora
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Marcello F Salgado Filho, MD, Principal investigator, Federal University of Juiz de Fora
ClinicalTrials.gov Identifier: NCT01619436     History of Changes
Other Study ID Numbers: 0279/03.05.2010
Study First Received: June 12, 2012
Last Updated: June 13, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Clonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013