Using Minimally Invasive Cardiac Output Data vs. Standard Care for Patients Emergently Admitted to the Intensive Care Unit Who Are Hemodynamically Unstable

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT00354211
First received: July 18, 2006
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

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 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: TREASURE: Treatment With Minimally-Invasive Cardiac Output for Assessment of User Derived Results Evaluating Economic Benefit

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population will include patients emergently admitted to the Intensive Care Unit who develop hemodynamic instability within 6 hours of admission.

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00354211

Locations
Finland
Kuopio University Hospital
Kuopio, Finland, 70211
Tampere Unversity Hospital
Tampere, Finland, 33521
Switzerland
University Hospital Bern (Inselspital)
Bern, Switzerland, 3010
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Principal Investigator: Jukka Takala, M.D., Ph.D. University Hospital Bern (Inselspital)
  More Information

Additional Information:
Publications:
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT00354211     History of Changes
Other Study ID Numbers: Study # 2005-06, Revision B
Study First Received: July 18, 2006
Last Updated: February 8, 2013
Health Authority: Switzerland: Ethikkommission
Germany: Ethics Commission

Keywords provided by Edwards Lifesciences:
Cardiac Output
Hemodynamic Phenomena

Additional relevant MeSH terms:
Cardiac Output, High
Cardiac Output, Low
Cardiovascular Diseases
Heart Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014