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How Much Cardiac Output is Enough?

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ClinicalTrials.gov Identifier: NCT00619281
Recruitment Status : Completed
First Posted : February 20, 2008
Last Update Posted : November 25, 2009
Sponsor:
Collaborators:
Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine
Klinikum der Stadt Ludwigshafen, Department of Cardiac Surgery
Information provided by:
Klinikum Ludwigshafen

Brief Summary:

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 or disease
Low Cardiac Output Syndrome

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].


Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective, Observational Study in Cardiac Surgery: How Much Cardiac Output is Enough?
Study Start Date : October 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort
Oberservation
600 consecutive patients undergoing cardiac surgery



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619281


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

Publications:
Responsible Party: Andreas Lehmann, MD, Klilnikum der Stadt Ludwigshafen, Dept of Anesthesiology and Intensive Care Medicine
ClinicalTrials.gov Identifier: NCT00619281     History of Changes
Other Study ID Numbers: CI-11-2007
klilu-11-2007-alehmann
First Posted: February 20, 2008    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

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

Additional relevant MeSH terms:
Cardiac Output, Low
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms