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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Klinikum Ludwigshafen
• Investigators: Principal Investigator: Andreas Lehmann, MD, Klinikum der Stadt Ludwigshafen, Departement of Anesthesiology and Intensive Care Medicine

Publications and helpful links

General 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. doi: 10.1053/j.jvca.2004.11.020. No abstract available.
• Bohrer 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. doi: 10.1016/s1053-0770(97)90211-1.
• 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. doi: 10.1056/NEJM199908263410901.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: January 3, 2008
• First Posted (Estimate): January 4, 2008

Study Record Updates

• Last Update Posted (Estimate): November 25, 2009
• Last Update Submitted That Met QC Criteria: November 23, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: cardiac surgery; mortality; morbidity; low cardiac output; natriuretic peptide B
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiac Output, Low
• Other Study ID Numbers: CI/NT-proBNP-12-2007