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

February 8, 2013 updated by: Edwards Lifesciences

TREASURE: Treatment With Minimally-Invasive Cardiac Output for Assessment of User Derived Results Evaluating Economic Benefit

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

392

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70211
        • Kuopio University Hospital
      • Tampere, Finland, 33521
        • Tampere Unversity Hospital
  • Switzerland
      • Bern, Switzerland, 3010
        • University hospital Bern (Inselspital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
FLOTRAC™ SYSTEM
Device: minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device)
2
Control Group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: Jukka Takala, M.D., Ph.D., University hospital Bern (Inselspital)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

July 18, 2006

First Submitted That Met QC Criteria

July 19, 2006

First Posted (Estimate)

July 20, 2006

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Study # 2005-06, Revision B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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