Esmolol in Cardiac Surgery (BREVI)
This study is currently recruiting participants.
Verified October 2012 by Università Vita-Salute San Raffaele
Sponsor:
Università Vita-Salute San Raffaele
Information provided by:
Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT00959569
First received: August 13, 2009
Last updated: October 11, 2012
Last verified: October 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 13, 2009 | ||||||||
| Last Updated Date | October 11, 2012 | ||||||||
| Start Date ICMJE | August 2009 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Composite endpoint or number of dead patients and/or number of patients requiring prolonged ICU stay. [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Reduce prolonged ICU stay / mortality [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT00959569 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
--ventricular fibrillation after cardiopulmonary bypass --low cardiac output syndrome --need for inotropic support --peak postoperative cardiac troponin level [ Designated as safety issue: No ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Esmolol in Cardiac Surgery | ||||||||
| Official Title ICMJE | Esmolol in Cardiac Surgery. A Randomized Controlled Trial With Clinical | ||||||||
| Brief Summary | This large randomized double-blind clinical trial (esmolol vs placebo) will enroll patients undergoing cardiac surgery to study the additive cardiac protection of this therapeutic strategy. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Cardiac Surgery | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Italy | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00959569 | ||||||||
| Other Study ID Numbers ICMJE | GO/URC/ER/mm 459/DG | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Landoni Giovanni, Vita-Salute University of Milano, Italy | ||||||||
| Study Sponsor ICMJE | Università Vita-Salute San Raffaele | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Università Vita-Salute San Raffaele | ||||||||
| Verification Date | October 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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