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Sponsored by: |
University Hospital, Strasbourg, France |
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Information provided by: | University Hospital, Strasbourg, France |
ClinicalTrials.gov Identifier: | NCT00699673 |
Objective: The purpose of the present study is to assess if perioperative variation of Brain Natriuretic Peptide (BNP) levels is a predictor of mortality and morbidity after cardiac surgery.Material and Methods: 500 consecutive patients will be enrolled prospectively in this study before cardiac surgery under cardiopulmonary bypass. BNP levels will be measured prior to surgery and at postoperative day 1. Variations of BNP levels will be analyzed to determine if it is a predictor of mortality and morbidity after cardiac surgery. This dynamic evaluation will be compared to other tools of risk stratification in cardiac surgery as the EuroScore. All patients will be followed 3 years after the procedure.
Hypothesis: Perioperative BNP variations may be more sensitive than pre- or postoperative BNP levels alone. Furthermore the perioperative homeostasis will be measured to assess its impact on BNP secretion during the perioperative period.
Condition |
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Coronary Artery Disease Valvular Disease |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Evaluation of the Brain Natriuretic Peptide as a Predictor of Morbidity and Mortality in Cardiac Surgery |
Estimated Enrollment: | 500 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2013 |
Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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No treatment |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patient who need cardiac surgery and age > 18 years
Inclusion Criteria:
Exclusion Criteria:
Contact: Michel KINDO, MD | 33-3-6955-0811 | michel.kindo@chru-strasbourg.fr |
France | |
Service de Chirurgie Cardio-Vasculaire au NHC, Hôpitaux Universitaires de Strasbourg | Recruiting |
Strasbourg, France, 67 091 | |
Contact: Michel KINDO, MD 33.3.69.55.08.11 michel.kindo@chru-strasbourg.fr | |
Contact: Michel KINDO, MD 33.3.69.55.08.11 michel.kindo@chru-strasbourg.fr | |
Principal Investigator: Michel KINDO, MD |
Principal Investigator: | Michel KINDO, MD | University Hospital, Strasbourg, France |
Responsible Party: | Organization: University Hospital, Strasbourg, France ( Emmanuel LAVOUE, directeur Adjoint ) |
Study ID Numbers: | 3910 |
Study First Received: | June 10, 2008 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00699673 |
Health Authority: | France: Ministry of Health |
Brain natriuretic peptide EuroScore Cardiac surgery Cardiopulmonary bypass |
Coronary artery disease Valvular disease Risk stratification in cardiac surgery |
Natriuretic Peptide, Brain Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Natriuretic Agents Therapeutic Uses Physiological Effects of Drugs |
Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |