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

Purpose

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.

Condition
Cardiac Surgery Low Cardiac Output Natriuretic Peptide B

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
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?

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure Heart Surgery

U.S. FDA Resources

Further study details as provided by Klinikum Ludwigshafen:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	150
Study Start Date:	July 2008
Study Completion Date:	April 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
NT-proBNP 150 consecutive patients undergoing cardiac surgery with an intraoperative measured cardiac output <2L/min/m².

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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]

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586027

Locations

Germany
Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine
Ludwigshafen, Germany, 67063

Sponsors and Collaborators

Klinikum Ludwigshafen

Investigators

Principal Investigator:

Andreas Lehmann, MD

Klinikum der Stadt Ludwigshafen, Departement of Anesthesiology and Intensive Care Medicine

More Information

Publications:

Hausmann H, Potapov EV, Koster A, Krabatsch T, Stein J, Yeter R, Kukucka M, Sodian R, Kuppe H, Hetzer R. Prognosis after the implantation of an intra-aortic balloon pump in cardiac surgery calculated with a new score. Circulation. 2002 Sep 24;106(12 Suppl 1):I203-6.

Lehmann A, Boldt J. New pharmacologic approaches for the perioperative treatment of ischemic cardiogenic shock. J Cardiothorac Vasc Anesth. 2005 Feb;19(1):97-108. Review. No abstract available.

Böhrer H, Schmidt H, Motsch J, Gust R, Bach A, Martin E. Gastric intramucosal pH: a predictor of survival in cardiac surgery patients with low cardiac output? J Cardiothorac Vasc Anesth. 1997 Apr;11(2):184-6.

Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999 Aug 26;341(9):625-34.

Adams HA, Baumann G, Gänsslen A, Janssens U, Knoefel W, Koch T, Marx G, Müller-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. German.

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.

Provenchère S, Berroeta C, Reynaud C, Baron G, Poirier I, Desmonts JM, Iung B, Dehoux M, Philip I, Bénessiano 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.

Pölönen P, Ruokonen E, Hippeläinen M, Pöyhönen M, Takala J. A prospective, randomized study of goal-oriented hemodynamic therapy in cardiac surgical patients. Anesth Analg. 2000 May;90(5):1052-9.

Responsible Party:	Dr Andreas Lehmann, Klinikum der Stadt Ludwigshafen, Department of Anaesthesiology and Intensive Care Medicine
ClinicalTrials.gov Identifier:	NCT00586027 History of Changes
Other Study ID Numbers:	CI/NT-proBNP-12-2007
Study First Received:	December 21, 2007
Last Updated:	November 23, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Klinikum Ludwigshafen:

cardiac surgery
low cardiac output
natriuretic peptide B
mortality
morbidity

Additional relevant MeSH terms:

Cardiac Output, Low
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013