Validation of the Fluid Responsiveness Index in Critically Ill Patients (FRI)
|ClinicalTrials.gov Identifier: NCT00894309|
Recruitment Status : Unknown
Verified May 2009 by Bicetre Hospital.
Recruitment status was: Not yet recruiting
First Posted : May 6, 2009
Last Update Posted : May 6, 2009
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 or disease|
|Shock Critically Ill|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Evaluation of the Validity of a New Index Provided by the PiCCO2 Device for Predicting Fluid Responsiveness in Critically Ill Patients|
|Study Start Date :||May 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894309
|Contact: Jean-Louis Teboul, MD, PhDfirstname.lastname@example.org|
|Medical Intensive Care Unit||Not yet recruiting|
|Le Kremlin-Bicêtre, France|
|Contact: Xavier Monnet, MD, PhD|
|Principal Investigator: Xavier Monnet, MD, PhD|
|Universitätsklinik Eppendorf||Not yet recruiting|
|Contact: Daniel Reuter, MD, PhD email@example.com|
|Klinikum Rechts der Isar||Not yet recruiting|
|Contact: Wolfgang Huber, MD, PhD firstname.lastname@example.org|
|Department of Anesthesiology and Intensive Care Sheba Medical Centre||Not yet recruiting|
|Tel Aviv, Israel|
|Contact: Azriel Perel, MD, PhD +972526667200 email@example.com|
|Unidad de cuidados intensivos, Fundacion Jimenez Diaz||Not yet recruiting|
|Contact: Fernando Suarez Sipmann, MD, PhD FSuarez@fjd.es|
|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|