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Sponsored by: |
Bicetre Hospital |
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Information provided by: | Bicetre Hospital |
ClinicalTrials.gov Identifier: | NCT00894309 |
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 |
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Shock Critically Ill |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Evaluation of the Validity of a New Index Provided by the PiCCO2 Device for Predicting Fluid Responsiveness in Critically Ill Patients |
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients with an acute circulatory failure
Inclusion Criteria:
Decision by the attending physician to give fluids will not be taken upon criteria predefined by the study protocol but considers:
Exclusion Criteria:
Contact: Jean-Louis Teboul, MD, PhD | +33145213547 | jean-louis.teboul@bct.aphp.fr |
France | |
Medical Intensive Care Unit | |
Le Kremlin-Bicêtre, France | |
Germany | |
Universitätsklinik Eppendorf | |
Hamburg, Germany | |
Klinikum Rechts der Isar | |
Munich, Germany | |
Israel | |
Department of Anesthesiology and Intensive Care Sheba Medical Centre | |
Tel Aviv, Israel | |
Spain | |
Unidad de cuidados intensivos, Fundacion Jimenez Diaz | |
Madrid, Spain |
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 |
Responsible Party: | Medical Intensive Care Unit - Bicêtre Hospital ( Prof Jean-Louis TEBOUL ) |
Study ID Numbers: | FRI-1 |
Study First Received: | May 5, 2009 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00894309 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Shock Critical Illness |
Disease Attributes Pathologic Processes Critical Illness |