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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Bicetre Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Bicetre Hospital
ClinicalTrials.gov Identifier:
NCT00894309
First received: May 5, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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.


Condition
Shock
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

Resource links provided by NLM:


Further study details as provided by Bicetre Hospital:

Estimated Enrollment: 80
Study Start Date: May 2009
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with an acute circulatory failure

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894309

Contacts
Contact: Jean-Louis Teboul, MD, PhD +33145213547 jean-louis.teboul@bct.aphp.fr

Locations
France
Medical Intensive Care Unit Not yet recruiting
Le Kremlin-Bicêtre, France
Contact: Xavier Monnet, MD, PhD         
Principal Investigator: Xavier Monnet, MD, PhD         
Germany
Universitätsklinik Eppendorf Not yet recruiting
Hamburg, Germany
Contact: Daniel Reuter, MD, PhD       dreuter@uke.uni-hamburg.de   
Klinikum Rechts der Isar Not yet recruiting
Munich, Germany
Contact: Wolfgang Huber, MD, PhD       wolfgg.huber@t-online.de   
Israel
Department of Anesthesiology and Intensive Care Sheba Medical Centre Not yet recruiting
Tel Aviv, Israel
Contact: Azriel Perel, MD, PhD    +972526667200    perelao@shani.net   
Spain
Unidad de cuidados intensivos, Fundacion Jimenez Diaz Not yet recruiting
Madrid, Spain
Contact: Fernando Suarez Sipmann, MD, PhD       FSuarez@fjd.es   
Sponsors and Collaborators
Bicetre Hospital
Investigators
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

No publications provided

Responsible Party: Prof Jean-Louis TEBOUL, Medical Intensive Care Unit - Bicêtre Hospital
ClinicalTrials.gov Identifier: NCT00894309     History of Changes
Other Study ID Numbers: FRI-1
Study First Received: May 5, 2009
Last Updated: May 5, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Critical Illness
Shock
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014