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Sponsors and Collaborators: |
Klinikum Ludwigshafen Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine Klinikum der Stadt Ludwigshafen, Department of Cardiac Surgery |
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Information provided by: | Klinikum Ludwigshafen |
ClinicalTrials.gov Identifier: | NCT00619281 |
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 |
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Low Cardiac Output Syndrome |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Prospective, Observational Study in Cardiac Surgery: How Much Cardiac Output is Enough? |
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 |
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Oberservation
600 consecutive patients undergoing cardiac surgery
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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].
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
600 patients undergoing cardiac surgery
Inclusion Criteria:
Exclusion Criteria:
Contact: Andreas Lehmann, MD | ++49/621/5033000 | lehmanna@klilu.de |
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 |
Study Director: | Joachim Boldt, MD | Klinikum Ludwigshafen, Department of Anesthesiology and Intensive Care medicine |
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 |
Cardiac surgery Low cardiac output syndrome Mortality Morbidity |
Signs and Symptoms Heart Diseases Cardiac Output, Low |
Pathologic Processes Disease Syndrome Cardiovascular Diseases |