How Much Cardiac Output is Enough?

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00619281
First received: December 28, 2007
Last updated: November 23, 2009
Last verified: November 2009

December 28, 2007
November 23, 2009
October 2007
July 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00619281 on ClinicalTrials.gov Archive Site
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How Much Cardiac Output is Enough?
Prospective, Observational Study in Cardiac Surgery: How Much Cardiac Output is Enough?

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.

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].

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

600 patients undergoing cardiac surgery

Low Cardiac Output Syndrome
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Oberservation
600 consecutive patients undergoing cardiac surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing cardiac surgery,
  • Written informed consent

Exclusion Criteria:

  • Missing consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00619281
CI-11-2007, klilu-11-2007-alehmann
No
Andreas Lehmann, MD, Klilnikum der Stadt Ludwigshafen, Dept of Anesthesiology and Intensive Care Medicine
Klinikum Ludwigshafen
  • Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine
  • Klinikum der Stadt Ludwigshafen, Department of Cardiac Surgery
Study Director: Joachim Boldt, MD Klinikum Ludwigshafen, Department of Anesthesiology and Intensive Care medicine
Klinikum Ludwigshafen
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP