FLOTRAC/VIGILEO in Acute Circulatory Failure (FLOVAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01090791
Recruitment Status : Terminated (Major change in protocol anticipated)
First Posted : March 23, 2010
Last Update Posted : September 8, 2016
Information provided by (Responsible Party):
Jerome Allardet-Servent, MD, Hôpital Européen Marseille

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.

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

Study Type : Observational
Actual Enrollment : 1 participants
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
Study Start Date : May 2011
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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

Primary Outcome Measures :
  1. 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 :
  1. SV cut-off with Flotrac/Vigileo and with TEE to predict fluid responsiveness [ Time Frame: 30 min ]
    ROC curve

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Jerome Allardet-Servent, MD, MD, MSc, Hôpital Européen Marseille Identifier: NCT01090791     History of Changes
Other Study ID Numbers: 2009-A007419-48
First Posted: March 23, 2010    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes