Clinical trial NCT00586027: Is There a Correlation of Natriuretic Propeptide Type B With an Intraoperative Low Cardiac Output?
Official title: 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?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Low Cardiac Output
Natriuretic Peptide B
Keywords: cardiac surgery
low cardiac output
natriuretic peptide B
mortality
morbidity
Lead sponsor: Klinikum Ludwigshafen
Sponsor class: OTHER
First posted: 2008-01-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 150 patients undergoing cardiac surgery, being monitored with a Swan-Ganz catheter and an intraoperatively before cardiopulmonary bypass measured cardiac index \<2L/min/m².

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.

Eligibility criteria: 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 \[\>123µmol/L\]

Primary outcomes:
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.
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine
Study officials:
affiliation: Klinikum der Stadt Ludwigshafen, Departement of Anesthesiology and Intensive Care Medicine
name: Andreas Lehmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Adams HA, Baumann G, Gansslen A, Janssens U, Knoefel W, Koch T, Marx G, Muller-Werdan U, Pape HC, Prange W, Roesner D, Standl T, Teske W, Werner G, Zander R; I.A.G.-Schock. [Definition of shock types]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2001 Nov;36 Suppl 2:S140-3. doi: 10.1055/s-2001-18174. German.
citation: Cerrahoglu M, Iskesen I, Tekin C, Onur E, Yildirim F, Sirin BH. N-terminal ProBNP levels can predict cardiac failure after cardiac surgery. Circ J. 2007 Jan;71(1):79-83. doi: 10.1253/circj.71.79.
citation: Provenchere S, Berroeta C, Reynaud C, Baron G, Poirier I, Desmonts JM, Iung B, Dehoux M, Philip I, Benessiano J. Plasma brain natriuretic peptide and cardiac troponin I concentrations after adult cardiac surgery: association with postoperative cardiac dysfunction and 1-year mortality. Crit Care Med. 2006 Apr;34(4):995-1000. doi: 10.1097/01.CCM.0000206110.94385.C4.
citation: Polonen P, Ruokonen E, Hippelainen M, Poyhonen M, Takala J. A prospective, randomized study of goal-oriented hemodynamic therapy in cardiac surgical patients. Anesth Analg. 2000 May;90(5):1052-9. doi: 10.1097/00000539-200005000-00010.