Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Edwards Lifesciences |
---|---|
Information provided by: | Edwards Lifesciences |
ClinicalTrials.gov Identifier: | NCT00354211 |
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 comparison to standard of care will shorten the time needed to stabilize the patient.
The researchers hypothesize that early detection of instability improves the prognosis and treatment outcome of emergency intensive care patients with hemodynamic instability.
Condition | Intervention | Phase |
---|---|---|
Cardiac Output, High Cardiac Output, Low |
Device: minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device) |
Phase IV |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | TREASURE: Treatment With Minimally-Invasive Cardiac Output for Assessment of User Derived Results Evaluating Economic Benefit |
Enrollment: | 392 |
Study Start Date: | July 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
1
FLOTRAC™ SYSTEM
|
Device: minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device) |
2
Control Group
|
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 been successfully used in a variety of patients to improve outcome. In contrast, a similar therapeutic approach applied later, or in patients with established multi-organ failure, has no beneficial effect and may even worsen the outcome.
It is conceivable that there is a window of opportunity during the phases of hemodynamic instability where therapeutic interventions have the greatest potential to influence the subsequent course of critical illness. Large scale uses of therapeutic protocols for early intervention have been hampered by logistic problems. The burden of installing invasive hemodynamic monitoring and protocols is labor intensive and requires a continuous presence of personnel with a thorough understanding of complex physiology. Various techniques have been introduced for monitoring cardiac output, stroke volume, or their surrogates. The disadvantage of these technologies so far have included user dependence of measurements results, need for calibration, and limitations in applicability. Edwards Lifesciences has developed a new algorithm for the determination of cardiac output using arterial pressure data. The FloTrac™ system, which includes the FloTrac™ sensor and Vigileo™ monitor, is utilized to capture the arterial pressure-based cardiac output measurement, which will be hereinafter referred to as APCO (Arterial Pressure Cardiac Output). This system uses an existing arterial catheter (placed in the femoral or radial artery) and does not require calibration by an external reference method. We hypothesize that using the FloTrac™ system to continuously monitor cardiac output, in addition to traditional vital signs, cardiovascular instability will be identified earlier and result in earlier intervention. In addition, following earlier diagnosis, more precise intervention will be available. If this can be achieved, patients will likely show better outcomes by reduced length of hospital stay, ICU time, Mechanical Ventilation time, incidence of renal compromise, and other related morbidity/mortality and need less ICUresources.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
The study population will include patients emergently admitted to the Intensive Care Unit who develop hemodynamic instability within 6 hours of admission.
Inclusion Criteria:
Exclusion Criteria:
Finland | |
Kuopio University Hospital | |
Kuopio, Finland, 70211 | |
Tampere Unversity Hospital | |
Tampere, Finland, 33521 | |
Switzerland | |
University Hospital Bern (Inselspital) | |
Bern, Switzerland, 3010 |
Principal Investigator: | Jukka Takala, M.D., Ph.D. | University Hospital Bern (Inselspital) |
Responsible Party: | Edwards Lifesciences Services GmbH ( Jayne Alice Debra Fawcett/ Director Clinical Studies ) |
Study ID Numbers: | Study # 2005-06, Revision B |
Study First Received: | July 18, 2006 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00354211 History of Changes |
Health Authority: | Switzerland: Ethikkommission; Germany: Ethics Commission |
Cardiac Output Hemodynamic Phenomena |
Signs and Symptoms Heart Diseases Cardiac Output, High Cardiac Output, Low |
Signs and Symptoms Heart Diseases Cardiovascular Diseases Cardiac Output, High Cardiac Output, Low |