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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 May 2010 by University Hospital, Strasbourg, France
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00699673
First received: June 10, 2008
Last updated: May 21, 2010
Last verified: May 2010
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Brain Natriuretic Peptide as a Predictor of Morbidity and Mortality in Cardiac Surgery

Resource links provided by NLM:

Drug Information available for: Nesiritide
U.S. FDA Resources

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 ]

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

No publications provided

Responsible Party: Christine GEILLER, director of Direction de la Recherche Clinique et des Innovations, Organization: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00699673     History of Changes
Other Study ID Numbers: 3910
Study First Received: June 10, 2008
Last Updated: May 21, 2010
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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013