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Validation of the Fluid Responsiveness Index in Critically Ill Patients (FRI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Bicetre Hospital.
Recruitment status was:  Not yet recruiting
Information provided by:
Bicetre Hospital Identifier:
First received: May 5, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted

Fluid therapy is an important part of the management of patients with hemodynamic instability in the intensive care unit. By increasing cardiac preload, it aims at elevating cardiac output (CO) and thus restoring hemodynamic conditions in patients who are preload responsive. By contrast, volume administration can be deleterious in terms of pulmonary edema formation or other manifestations or fluid overload, especially in patients who are not preload responsive. Functional dynamic parameters that use heart-lung interactions, such as pulse pressure variation (PPV) and stroke volume variation (SVV) are considered accurate predictors of preload responsiveness in patients receiving fully controlled mechanical ventilation.

However, in cases of spontaneous breathing activity where heart-lung interaction indices fail to predict fluid responsiveness, one needs parameters able to reliably predict the hemodynamic response of fluid administration.

A new index that could indicate fluid responsiveness, so-called the fluid responsiveness index (FRI), has been elaborated. The advantage is that it could be used in patients who are not in control mechanical ventilation as well as in patients who are fully adapted to mechanical ventilation.

The FRI is based upon the analysis of continuous arterial and continuous central venous pressure. The FRI is determined by the relation of cardiac and respiratory activity; both are evaluated by means of power spectrum analysis of the pressures recorded.

The aim of this study is to test the value of the FRI to predict the hemodynamic response to fluid infusion in patients with hemodynamic instability not receiving fully controlled mechanical ventilation.

Critically Ill

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Validity of a New Index Provided by the PiCCO2 Device for Predicting Fluid Responsiveness in Critically Ill Patients

Further study details as provided by Bicetre Hospital:

Estimated Enrollment: 80
Study Start Date: May 2009

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with an acute circulatory failure

Inclusion Criteria:

  • Age ≥ 18 years
  • Hospitalization in an intensive care unit
  • Presence of an acute circulatory failure as defined by the presence of at least one clinical sign of inadequate global perfusion
  • Decision by the attending physician to give fluids will not be taken upon criteria predefined by the study protocol but considers:

    • systolic arterial pressure < 90 mmHg (or fall of systolic arterial pressure of more than 50 mmHg in known hypertensive patients)
    • urinary flow < 0.5 ml/kg/hr than two hours
    • tachycardia ≥ 100 beats/min
    • delayed capillary refill
    • mottled skin
    • high lactate
    • CO (Cardiac Output) that is not considered adequate and
    • low GEDV (Global EndDiastolic Volume)
  • Monitoring by a PiCCO2™ device (Pulsion Medical Systems, Munich, Germany) already in place as part of the routine hemodynamic monitoring

Exclusion Criteria:

  • Clinical evidence of pulmonary edema, hypervolemia or ELWI > 10 ml/kg
  Contacts and Locations
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Please refer to this study by its identifier: NCT00894309

Contact: Jean-Louis Teboul, MD, PhD +33145213547

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Sponsors and Collaborators
Bicetre Hospital
Principal Investigator: Xavier Monnet, MD, PhD Medical Intensive Care Unit - Bicêtre Hospital
Principal Investigator: Azriel Perel, MD, PhD Department of Anesthesiology and Intensive Care Sheba Medical Centre Tel Aviv
Principal Investigator: Jean-Louis Teboul, MD, PhD Medical Intensive Care Unit - Bicêtre Hospital
Principal Investigator: Daniel Reuter, MD, PhD Universitätsklinik Eppendorf, Hamburg
Principal Investigator: Wolfgang Huber, MD, PhD II. Med. Klinik, Station 2/11, Munich
Principal Investigator: Fernando Suarez Sipmann, MD, PhD Unidad de cuidados intensivos, Fundacion Jimenez Diaz, Madrid
  More Information

Responsible Party: Prof Jean-Louis TEBOUL, Medical Intensive Care Unit - Bicêtre Hospital Identifier: NCT00894309     History of Changes
Other Study ID Numbers: FRI-1
Study First Received: May 5, 2009
Last Updated: May 5, 2009

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes processed this record on April 26, 2017