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

This study has been completed.
Sponsor:
Information provided by:
Klinikum Ludwigshafen
ClinicalTrials.gov Identifier:
NCT00586027
First received: December 21, 2007
Last updated: November 23, 2009
Last verified: November 2009

December 21, 2007
November 23, 2009
July 2008
March 2009   (final data collection date for primary outcome measure)
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. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00586027 on ClinicalTrials.gov Archive Site
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Is There a Correlation of Natriuretic Propeptide Type B With an Intraoperative Low Cardiac Output?
Prospective Observational Study in Patients Undergoing Cardiac Surgery: Part 2: Is There a Correlation of Natriuretic Propeptide Type B With an Intraoperative Low Cardiac Output?

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

150 patients undergoing cardiac surgery, being monitored with a Swan-Ganz catheter and an intraoperatively before cardiopulmonary bypass measured cardiac index <2L/min/m².

  • Cardiac Surgery
  • Low Cardiac Output
  • Natriuretic Peptide B
Not Provided
NT-proBNP
150 consecutive patients undergoing cardiac surgery with an intraoperative measured cardiac output <2L/min/m².

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
April 2009
March 2009   (final data collection date for primary outcome measure)

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]
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00586027
CI/NT-proBNP-12-2007
No
Dr Andreas Lehmann, Klinikum der Stadt Ludwigshafen, Department of Anaesthesiology and Intensive Care Medicine
Klinikum Ludwigshafen
Not Provided
Principal Investigator: Andreas Lehmann, MD Klinikum der Stadt Ludwigshafen, Departement of Anesthesiology and Intensive Care Medicine
Klinikum Ludwigshafen
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP