Validation of the Fluid Responsiveness Index in Critically Ill Patients (FRI)
Recruitment status was Not yet recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Eligibility| 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:
- 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| Contact: Jean-Louis Teboul, MD, PhD | +33145213547 | jean-louis.teboul@bct.aphp.fr |
| 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 | |
| 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 May 23, 2013