Evaluation of the Brain Natriuretic Peptide as a Predictor of Morbidity and Mortality in Cardiac Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00699673|
Recruitment Status : Unknown
Verified August 2015 by University Hospital, Strasbourg, France.
Recruitment status was: Active, not recruiting
First Posted : June 18, 2008
Last Update Posted : August 7, 2015
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 or disease|
|Coronary Artery Disease Valvular Disease|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Evaluation of the Brain Natriuretic Peptide as a Predictor of Morbidity and Mortality in Cardiac Surgery|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
- BNP levels; hospital and long-term morbidity and mortality [ Time Frame: BNP levels prior to surgery and at postoperative day 1; Hospital and long-term morbidity and mortality (1, 2 and 3 years) ]
- EuroScoreCardiac markers; inflammation markers; echocardiography [ Time Frame: EuroScoreCardiac markers at day 1, 2, 5; Inflammation markers at day 1, 2, 5; Echocardiography (day 5, and 1, 2 and 3 years) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699673
|Service de Chirurgie Cardio-Vasculaire au NHC, Hôpitaux Universitaires de Strasbourg|
|Strasbourg, France, 67 091|
|Principal Investigator:||Michel KINDO, MD||University Hospital, Strasbourg, France|