Validation of the Fluid Responsiveness Index in Critically Ill Patients

NCT00894309 | Unknown

• 1 other identifier: FRI-1
• Study Type: observational
• Target: 80
• Locations: 4 countries
• Sites: 5

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with an acute circulatory failure

You may qualify if:

• 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

You may not qualify if:

• Clinical evidence of pulmonary edema, hypervolemia or ELWI \> 10 ml/kg

Sponsors & Collaborators

• Bicetre Hospital: lead

Study Sites (5)

Medical Intensive Care Unit

Le Kremlin-Bicêtre, France

Location

Universitätsklinik Eppendorf

Hamburg, Germany

Location

Klinikum Rechts der Isar

Munich, Germany

Location

Department of Anesthesiology and Intensive Care Sheba Medical Centre

Tel Aviv, Israel

Location

Unidad de cuidados intensivos, Fundacion Jimenez Diaz

Madrid, Spain

Location

MeSH Terms

Conditions

Shock; Critical Illness

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Louis Teboul, MD, PhD

CONTACT

+33145213547; jean-louis.teboul@bct.aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 6, 2009
• Study Start: May 1, 2009
• Last Updated: May 6, 2009

Record last verified: 2009-05

Locations

DE (2); IL (1); FR (1); ES (1)