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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:
Federal University of Juiz de Fora
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
| 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 |
sedation [ Time Frame: 2 years ] Clonidine 2 mg/kg IV. assessment sedation with Ransay scale |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Change History | No Changes Posted | ||
| Current Secondary Outcome Measures ICMJE |
Glycemia [ Time Frame: 2 years ] clonide 2 mg/kg. assessment the glycemia during CPB. |
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| 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 Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms |
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| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| 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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 | ||
| Plan to Share Data | Not Provided | ||
| IPD Description | 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 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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