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Evaluation of the Brain Natriuretic Peptide as a Predictor of Morbidity and Mortality in Cardiac Surgery
This study is currently recruiting participants.
Verified by University Hospital, Strasbourg, France, December 2008
Sponsored by: University Hospital, Strasbourg, France
Information provided by: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00699673
  Purpose

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
Coronary Artery Disease
Valvular Disease

MedlinePlus related topics: Coronary Artery Disease Heart Surgery
Drug Information available for: Nesiritide
U.S. FDA Resources
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

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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
No treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient who need cardiac surgery and age > 18 years

Criteria

Inclusion Criteria:

  • Patient who need cardiac surgery
  • Age > 18 years

Exclusion Criteria:

  • Patient on mechanic ventilation before surgery
  • Aortic dissection-Congenital disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699673

Contacts
Contact: Michel KINDO, MD 33-3-6955-0811 michel.kindo@chru-strasbourg.fr

Locations
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            
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Michel KINDO, MD University Hospital, Strasbourg, France
  More Information

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

Keywords provided by University Hospital, Strasbourg, France:
Brain natriuretic peptide
EuroScore
Cardiac surgery
Cardiopulmonary bypass
Coronary artery disease
Valvular disease
Risk stratification in cardiac surgery

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009