Validation of the Fluid Responsiveness Index in Critically Ill Patients

Critically Ill Clinical Trial

— FRI  

Official title:

Evaluation of the Validity of a New Index Provided by the PiCCO2 Device for Predicting Fluid Responsiveness in Critically Ill Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00894309
• Other study ID #: FRI-1
• Status: Not yet recruiting
• Phase: N/A
• First received: May 5, 2009
• Last updated: May 5, 2009
• Start date: May 2009

Study information

• Verified date: May 2009
• Source: Bicetre Hospital
• Contact: Jean-Louis Teboul, MD, PhD
• Phone: +33145213547
• Email: jean-louis.teboul[@]bct.aphp.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Shock

Locations

Country	Name	City	State
France	Medical Intensive Care Unit	Le Kremlin-Bicêtre
Germany	Universitätsklinik Eppendorf	Hamburg
Germany	Klinikum Rechts der Isar	Munich
Israel	Department of Anesthesiology and Intensive Care Sheba Medical Centre	Tel Aviv
Spain	Unidad de cuidados intensivos, Fundacion Jimenez Diaz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Bicetre Hospital

Countries where clinical trial is conducted

France,  Germany,  Israel,  Spain,