Overview

This trial is active, not recruiting.

Conditions coronary artery disease, valvular disease
Sponsor University Hospital, Strasbourg, France
Start date June 2008
End date June 2017
Trial size 500 participants
Trial identifier NCT00699673, 3910

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
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)

Secondary Outcomes

Measure
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)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient who need cardiac surgery - Age > 18 years Exclusion Criteria: - Patient on mechanic ventilation before surgery - Aortic dissection-Congenital disease

Additional Information

Official title Evaluation of the Brain Natriuretic Peptide as a Predictor of Morbidity and Mortality in Cardiac Surgery
Principal investigator Michel KINDO, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by University Hospital, Strasbourg, France.