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How Much Cardiac Output is Enough?
This study is currently recruiting participants.
Verified by Klinikum Ludwigshafen, May 2008
Sponsors and Collaborators: Klinikum Ludwigshafen
Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine
Klinikum der Stadt Ludwigshafen, Department of Cardiac Surgery
Information provided by: Klinikum Ludwigshafen
ClinicalTrials.gov Identifier: NCT00619281
  Purpose

Low output syndrome is a common complication in patients undergoing cardiac surgery. Its incidence was reported to be 2 to 6% [1]. Morbidity and mortality of low output syndrome is high and the costs for treating the disease are immense.

The primary objective of this prospective observational study is to define a threshold for a critically reduced cardiac output requiring immediate therapy.


Condition
Low Cardiac Output Syndrome

MedlinePlus related topics: Heart Failure Heart Surgery
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Prospective, Observational Study in Cardiac Surgery: How Much Cardiac Output is Enough?

Further study details as provided by Klinikum Ludwigshafen:

Primary Outcome Measures:
  • The primary objective is to try to define a threshold value for a critically reduced cardiac output or cardiac index requiring immediate therapy to reduce mortality and morbidity. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 600
Study Start Date: October 2007
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Oberservation
600 consecutive patients undergoing cardiac surgery

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].

The primary objective of this prospective observational study in 600 patients undergoing cardiac surgery is to try to define a threshold for a critically reduced cardiac output or cardiac index requiring immediate therapy.

If cardiac output and cardiac index are not reduced below a critical threshold, morbidity, mortality, and length of stay in the intensive care unit and in the hospital are reduced [6].

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

600 patients undergoing cardiac surgery

Criteria

Inclusion Criteria:

  • Patients undergoing cardiac surgery,
  • Written informed consent

Exclusion Criteria:

  • Missing consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619281

Contacts
Contact: Andreas Lehmann, MD ++49/621/5033000 lehmanna@klilu.de

Locations
Germany
Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine Recruiting
Ludwigshafen, Germany, 67063
Contact: Andreas Lehmann, MD     ++49/621/5033000     lehmanna@klilu.de    
Contact: Joachim Boldt, MD     ++49/621/5033000     boldtj@klilu.de    
Principal Investigator: Andreas Lehmann, MD            
Sponsors and Collaborators
Klinikum Ludwigshafen
Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine
Klinikum der Stadt Ludwigshafen, Department of Cardiac Surgery
Investigators
Study Director: Joachim Boldt, MD Klinikum Ludwigshafen, Department 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.
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: Klilnikum der Stadt Ludwigshafen, Dept of Anesthesiology and Intensive Care Medicine ( Andreas Lehmann, MD )
Study ID Numbers: CI-11-2007, klilu-11-2007-alehmann
Study First Received: December 28, 2007
Last Updated: May 5, 2008
ClinicalTrials.gov Identifier: NCT00619281  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Klinikum Ludwigshafen:
Cardiac surgery
Low cardiac output syndrome
Mortality
Morbidity

Study placed in the following topic categories:
Signs and Symptoms
Heart Diseases
Cardiac Output, Low

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009