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FLOTRAC/VIGILEO in Acute Circulatory Failure (FLOVAC)

This study has been terminated.
(Major change in protocol anticipated)
Information provided by (Responsible Party):
Jerome Allardet-Servent, MD, Hôpital Européen Marseille Identifier:
First received: March 22, 2010
Last updated: September 7, 2016
Last verified: September 2016
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.

Condition Intervention
Critically Ill Acute Circulatory Failure Fluid Loading Device: Flotrac/Vigileo third generation software Device: Transthoracic echocardiography

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Assessment of the FLOTRAC/VIGILEO Third Generation Software to Predict Fluid Responsiveness in Critically Ill Patient With Acute Circulatory Failure

Resource links provided by NLM:

Further study details as provided by Jerome Allardet-Servent, MD, Hôpital Européen Marseille:

Primary Outcome Measures:
  • Stroke volume measurement between Flotrac/Vigileo device and transthoracic echocardiography [ Time Frame: 30 min ]
    Bland-Altman analysis of the whole SV measurements

Secondary Outcome Measures:
  • SV cut-off with Flotrac/Vigileo and with TEE to predict fluid responsiveness [ Time Frame: 30 min ]
    ROC curve

  • SVV cut-off with Flotrac/Vigileo to predict fluid responsiveness [ Time Frame: 30 min ]
    ROC curve

Enrollment: 1
Study Start Date: May 2011
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Flotrac/Vigileo third generation software
    Measurement of stroke volume according to the arterial pressure waveform
    Device: Transthoracic echocardiography
    Measurement of stroke volume according to the aortic time-velocity integral

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients with acute circulatory failure, as defined by two or more of the inclusion 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01090791

Hopital Paul Desbief
Marseille, France, 13002
Hopital Ambroise Paré
Marseille, France, 13006
Sponsors and Collaborators
Hôpital Européen Marseille
Principal Investigator: Jérôme Allardet-Servent, MD,MSc Fondation Hôpital Ambroise Paré
  More Information

Responsible Party: Jerome Allardet-Servent, MD, MD, MSc, Hôpital Européen Marseille Identifier: NCT01090791     History of Changes
Other Study ID Numbers: 2009-A007419-48
Study First Received: March 22, 2010
Last Updated: September 7, 2016

Keywords provided by Jerome Allardet-Servent, MD, Hôpital Européen Marseille:
critically ill patient

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes processed this record on August 17, 2017