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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 29, 2014