Validation of the Fluid Responsiveness Index in Critically Ill Patients

NCT ID: NCT00894309

Last Updated: 2009-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31

Brief 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.

Conditions

Shock; Critically Ill

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bicetre Hospital

OTHER

Sponsor Role: lead

Responsible Party

Medical Intensive Care Unit - Bicêtre Hospital

Principal Investigators

Xavier Monnet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Intensive Care Unit - Bicêtre Hospital

Azriel Perel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Intensive Care Sheba Medical Centre Tel Aviv

Jean-Louis Teboul, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Intensive Care Unit - Bicêtre Hospital

Daniel Reuter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik Eppendorf, Hamburg

Wolfgang Huber, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

II. Med. Klinik, Station 2/11, Munich

Fernando Suarez Sipmann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Unidad de cuidados intensivos, Fundacion Jimenez Diaz, Madrid

Locations

Medical Intensive Care Unit

Le Kremlin-Bicêtre, , France

Universitätsklinik Eppendorf

Hamburg, , Germany

Klinikum Rechts der Isar

Munich, , Germany

Department of Anesthesiology and Intensive Care Sheba Medical Centre

Tel Aviv, , Israel

Unidad de cuidados intensivos, Fundacion Jimenez Diaz

Madrid, , Spain

Countries

France; Germany; Israel; Spain

Central Contacts

Jean-Louis Teboul, MD, PhD

Role: CONTACT

jean-louis.teboul@bct.aphp.fr

+33145213547

Facility Contacts

Xavier Monnet, MD, PhD

Role: primary

Daniel Reuter, MD, PhD

Role: primary

dreuter@uke.uni-hamburg.de

Wolfgang Huber, MD, PhD

Role: primary

wolfgg.huber@t-online.de

Azriel Perel, MD, PhD

Role: primary

perelao@shani.net

+972526667200

Fernando Suarez Sipmann, MD, PhD

Role: primary

FSuarez@fjd.es

Other Identifiers

FRI-1

Identifier Type: -

Identifier Source: org_study_id