Evaluation of the Brain Natriuretic Peptide as a Predictor of Morbidity and Mortality in Cardiac Surgery

• Conditions: Coronary Artery Disease; Valvular Disease

• Registration Number: NCT00699673
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-10
• Study First Submitted QC: 2008-06-16
• Study First Posted: 2008-06-18
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-06
• Last Update Posted: 2015-08-07
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patient who need cardiac surgery
• Age > 18 years

Exclusion Criteria

• Patient on mechanic ventilation before surgery
• Aortic dissection-Congenital disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BNP levels; hospital and long-term morbidity and mortality	BNP levels prior to surgery and at postoperative day 1; Hospital and long-term morbidity and mortality (1, 2 and 3 years)

Secondary Outcome Measures

Name	Time	Method
EuroScoreCardiac markers; inflammation markers; echocardiography	EuroScoreCardiac markers at day 1, 2, 5; Inflammation markers at day 1, 2, 5; Echocardiography (day 5, and 1, 2 and 3 years)

Trial Locations

Locations (1)

Service de Chirurgie Cardio-Vasculaire au NHC, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France