Status:
COMPLETED
Using Minimally Invasive Cardiac Output Data vs. Standard Care for Patients Emergently Admitted to the Intensive Care Unit Who Are Hemodynamically Unstable
Lead Sponsor:
Edwards Lifesciences
Conditions:
Cardiac Output, High
Cardiac Output, Low
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate if the continuous availability of minimally invasive cardiac output data during treatment in the intensive care unit (ICU) for hemodynamic instability, in comp...
Detailed Description
Hemodynamic instability during the first 24-hours of Intensive Care Unit (ICU) admission is associated with increased risk of subsequent morbidity and mortality. Goal-directed hemodynamic support has ...
Eligibility Criteria
Inclusion
- Patient newly admitted to the ICU due to an emergency unplanned admission.
- Patient diagnosed with hemodynamic instability at or becomes unstable within 6 hours of ICU admission.
- Patient must require an indwelling radial or a femoral artery catheter.
- Patient is included in the study according to the specific regulations of the participating center: this may include a deferred consent, consent by designee, consent by independent physician or a combination thereof.
- Patient must be 18 years old or older.
Exclusion
- Patients with contraindications for the placement of radial, femoral, dorsalis pedis, or other arterial cannula.
- Patients with a pulmonary artery catheter.
- Patients who are hemodynamically stable.
- Patients with history or clinical findings of aortic valve regurgitation.
- Patients being treated with an intra-aortic balloon pump.
- Female patient is pregnant.
- Patient is currently participating in an investigational drug or another device study.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT00354211
Start Date
July 1 2006
End Date
December 1 2007
Last Update
February 11 2013
Active Locations (3)
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1
Kuopio University Hospital
Kuopio, Finland, 70211
2
Tampere Unversity Hospital
Tampere, Finland, 33521
3
University Hospital Bern (Inselspital)
Bern, Switzerland, 3010