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How Much Cardiac Output is Enough?

Prospective, Observational Study in Cardiac Surgery: How Much Cardiac Output is Enough?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00619281
Enrollment
600
Registered
2008-02-20
Start date
2007-10-31
Completion date
2008-07-31
Last updated
2009-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Cardiac Output Syndrome

Keywords

Cardiac surgery, Low cardiac output syndrome, Mortality, Morbidity

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.

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 \[6\].

Interventions

None listed

Sponsors

Klinikum Ludwigshafen
Lead SponsorOTHER
Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine
CollaboratorUNKNOWN
Klinikum der Stadt Ludwigshafen, Department of Cardiac Surgery
CollaboratorUNKNOWN

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing cardiac surgery, * Written informed consent

Exclusion criteria

* Missing consent

Design outcomes

Primary

MeasureTime frame
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.90 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026