How Much Cardiac Output is Enough?
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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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Prospective, Observational Study in Cardiac Surgery: How Much Cardiac Output is Enough? |
- 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 ]
| Estimated Enrollment: | 600 |
| Study Start Date: | October 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 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 |
600 patients undergoing cardiac surgery
Inclusion Criteria:
- Patients undergoing cardiac surgery,
- Written informed consent
Exclusion Criteria:
- Missing consent
Contacts and Locations| Germany | |
| Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine | |
| Ludwigshafen, Germany, 67063 | |
| Study Director: | Joachim Boldt, MD | Klinikum Ludwigshafen, Department of Anesthesiology and Intensive Care medicine |
More Information
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 |
| Study First Received: | December 28, 2007 |
| Last Updated: | November 23, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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 |
ClinicalTrials.gov processed this record on June 18, 2013