Is There a Correlation of Natriuretic Propeptide Type B With an Intraoperative Low Cardiac Output?

Completed

• Conditions: Cardiac Surgery; Low Cardiac Output; Natriuretic Peptide B

• Registration Number: NCT00586027
• Lead Sponsor: Klinikum Ludwigshafen

Brief Summary

Low output syndrome is a common complication in patients undergoing cardiac surgery. Its incidence was reported to be 2 to 6%. Morbidity and mortality of low output syndrome is high and the costs for treating the disease are immense.Natriuretic propeptide Type B (NT-proBNP) is a biological marker for the diagnosis, prognosis and therapy of cardiac failure after cardiac surgery.

Cardiac index and NT-proBNP will be correlated with morbidity and mortality. A critical threshold value for intraoperative cardiac index and NT-proBNP will be calculated.

Detailed Description

Low output syndrome is a common complication in patients undergoing cardiac surgery. Its incidence was reported to be 2 to 6% \[1\]. In patients suffering from low output syndrome cardiac output is severely reduced due to myocardial failure. Among other reasons for myocardial failure, ischemia, insufficient myocardial protection during aortic cross-clamping, and severely reduced ventricular function prior surgery are the most common risk factors for low output syndrome. Low output syndrome is treated with positive inotropic drugs and mechanical assist devices \[2\]. Morbidity and mortality of low output syndrome is high and the costs for treating the disease are immense.

If cardiac output cannot be increased cardiac failure persist and vital organs are hypoperfused. Critical and prolonged hypoperfusion results in single and multi organ failure. Until today a definite threshold for a critically reduced cardiac output or cardiac index requiring immediate therapy is not completely known. Cardiogenic shock is diagnosed by clinical signs and it is not diagnosed by cardiac output or cardiac index. The critical value for a severely reduces cardiac index was reported to be in a range of 1.75 to 2.5L/min/m² \[3-5\].

Natriuretic propeptide Type B (NT-proBNP) is a biological marker for the diagnosis, prognosis and therapy of cardiac failure after cardiac surgery \[6,7\].

The primary objective of this prospective observational study in 150 patients undergoing cardiac surgery with an intraoperative measured cardiac output \<2L/min/m² is to monitor NT-proBNP for 7 days. Cardiac index and NT-proBNP will be correlated with morbidity and mortality \[8\]. A critical threshold value for intraoperative cardiac index and NT-proBNP will be calculated.

Study Timeline

• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2008-01-03
• Study First Posted: 2008-01-04
• Study Start: 2008-07
• Primary Completion: 2009-03
• Study Completion: 2009-04
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-23
• Last Update Posted: 2009-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Adult patient undergoing cardiac surgery
• Written informed consent
• Cardiac index before cardiopulmonary bypass <2L/min/m²

Exclusion Criteria

• Missing consent
• Serum creatinine >1.5mg/dL [>123µmol/L]

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to monitor NT-proBNP for 7 days in patients with an intraoperative low cardiac output. Cardiac index and NT-proBNP will be correlated with morbidity and mortality.	90 days

Trial Locations

Locations (1)

Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine; 🇩🇪 Ludwigshafen, Germany