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

NCT00586027 | Completed

• 1 other identifier: CI/NT-proBNP-12-2007
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery; Low Cardiac Output; Natriuretic Peptide B

Keywords

cardiac surgery; low cardiac output; natriuretic peptide B; mortality; morbidity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

NT-proBNP

150 consecutive patients undergoing cardiac surgery with an intraoperative measured cardiac output \<2L/min/m².

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Klinikum Ludwigshafen: lead

Study Sites (1)

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

Ludwigshafen, 67063, Germany

Location

Related Publications (8)

• 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.

  PMID: 12354734 BACKGROUND

• 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.

  PMID: 15747280 BACKGROUND

• 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.

  PMID: 9105990 BACKGROUND

• 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.

  PMID: 10460813 BACKGROUND

• 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.

  PMID: 11753724 BACKGROUND

• 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.

  PMID: 17186982 BACKGROUND

• 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.

  PMID: 16484891 BACKGROUND

• 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.

  PMID: 10781452 BACKGROUND

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Lehmann, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: November 25, 2009

Record last verified: 2009-11

Locations

DE (1)