Clinical trial NCT00894309: Validation of the Fluid Responsiveness Index in Critically Ill Patients
Official title: Evaluation of the Validity of a New Index Provided by the PiCCO2 Device for Predicting Fluid Responsiveness in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shock
Critically Ill
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
First posted: 2009-05-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an acute circulatory failure

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Medical Intensive Care Unit
city: Hamburg
country: Germany
facility: Universitätsklinik Eppendorf
city: Munich
country: Germany
facility: Klinikum Rechts der Isar
city: Tel Aviv
country: Israel
facility: Department of Anesthesiology and Intensive Care Sheba Medical Centre
city: Madrid
country: Spain
facility: Unidad de cuidados intensivos, Fundacion Jimenez Diaz
Study officials:
affiliation: Medical Intensive Care Unit - Bicêtre Hospital
name: Xavier Monnet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology and Intensive Care Sheba Medical Centre Tel Aviv
name: Azriel Perel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Intensive Care Unit - Bicêtre Hospital
name: Jean-Louis Teboul, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinik Eppendorf, Hamburg
name: Daniel Reuter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: II. Med. Klinik, Station 2/11, Munich
name: Wolfgang Huber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unidad de cuidados intensivos, Fundacion Jimenez Diaz, Madrid
name: Fernando Suarez Sipmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: