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
  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?

Resource links provided by NLM:


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 ]

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
Study Population

600 patients undergoing cardiac surgery

Criteria

Inclusion Criteria:

  • Patients undergoing cardiac surgery,
  • Written informed consent

Exclusion Criteria:

  • Missing consent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  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:
Syndrome
Cardiac Output, Low
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014