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Clinical Trials/NCT01090791
NCT01090791
Terminated
Not Applicable

Assessment of the FLOTRAC/VIGILEO Third Generation Software to Predict Fluid Responsiveness in Critically Ill Patient With Acute Circulatory Failure

Hôpital Européen Marseille2 sites in 1 country1 target enrollmentMay 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critically Ill
Sponsor
Hôpital Européen Marseille
Enrollment
1
Locations
2
Primary Endpoint
Stroke volume measurement between Flotrac/Vigileo device and transthoracic echocardiography
Status
Terminated
Last Updated
9 years ago

Overview

Brief Summary

Acute circulatory failure may be related to hypovolemia. Fluid loading increases stroke volume in approximatively half of challenges. Determining fluid responsiveness prevents unnecessary fluid loading. Passive leg raising (PLR) provides a transient increase of 300 ml in venous return for a short time. The measurement of stroke volume (SV) before and after a PLR test allows physician to detect fluid responsiveness, when stroke volume increases is higher than 15 %. Beside thermodilution, the use of non invasive device to measure stroke volume becomes largely employed. Arterial Pressure based Cardiac Output (APCO), provided by the Flotrac/Vigileo system, does not required specific materials nor repeated calibration. The third generation software is believed to be more accurate and more precise for SV measurement. The aim of this study is to test the performance of the Flotrac/Vigileo device in a situation of rapid venous return changes induced by PLR and then by fluid loading. Patients will be classify posteriorly in responders and non responders, according to the magnitude of the fluid loading-induced SV changes measured by transthoracic echocardiography.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
September 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hôpital Européen Marseille
Responsible Party
Principal Investigator
Principal Investigator

Jerome Allardet-Servent, MD

MD, MSc

Hôpital Européen Marseille

Eligibility Criteria

Inclusion Criteria

  • Systolic arterial pressure \< 90 mmHg or Mean arterial pressure \< 60 mmHg
  • Heart rate \> 100 bpm
  • Norepinephrine infusion
  • Urine output \< 0.5 ml/kg/h during at least two consecutive hours
  • skin mottling
  • Capillary refill time \> 3 sec

Exclusion Criteria

  • Acute cor pulmonale
  • Ongoing renal replacement therapy
  • Lack of echogenicity during transthoracic echocardiography

Outcomes

Primary Outcomes

Stroke volume measurement between Flotrac/Vigileo device and transthoracic echocardiography

Time Frame: 30 min

Bland-Altman analysis of the whole SV measurements

Secondary Outcomes

  • SVV cut-off with Flotrac/Vigileo to predict fluid responsiveness(30 min)
  • SV cut-off with Flotrac/Vigileo and with TEE to predict fluid responsiveness(30 min)

Study Sites (2)

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