Status:
UNKNOWN
Validation of the Fluid Responsiveness Index in Critically Ill Patients
Lead Sponsor:
Bicetre Hospital
Conditions:
Shock
Critically Ill
Eligibility:
All Genders
18-90 years
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 th...
Eligibility Criteria
Inclusion
- 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
- Clinical evidence of pulmonary edema, hypervolemia or ELWI \> 10 ml/kg
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00894309
Start Date
May 1 2009
Last Update
May 6 2009
Active Locations (5)
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1
Medical Intensive Care Unit
Le Kremlin-Bicêtre, France
2
Universitätsklinik Eppendorf
Hamburg, Germany
3
Klinikum Rechts der Isar
Munich, Germany
4
Department of Anesthesiology and Intensive Care Sheba Medical Centre
Tel Aviv, Israel