FLOTRAC/VIGILEO in Acute Circulatory Failure (FLOVAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Hôpital Européen Marseille
Sponsor:
Information provided by (Responsible Party):
Jerome Allardet-Servent, MD, Hôpital Européen Marseille
ClinicalTrials.gov Identifier:
NCT01090791
First received: March 22, 2010
Last updated: May 18, 2014
Last verified: May 2014
  Purpose

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 Hôpital Européen Marseille:

Primary Outcome Measures:
  • Stroke volume measurement between Flotrac/Vigileo device and transthoracic echocardiography [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    ROC curve

  • SVV cut-off with Flotrac/Vigileo to predict fluid responsiveness [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    ROC curve


Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090791

Contacts
Contact: Jérôme Allardet-Servent, MD,MSc +33491833867 j_allardet@ch-ambroisepare.fr

Locations
France
Hopital Ambroise Paré Recruiting
Marseille, France, 13006
Contact: Jérôme Allardet-Servent, MD, MSc       j_allardet@ch-ambroisepare.fr   
Principal Investigator: Jérôme Allardet-Servent, MD, MSc         
Sub-Investigator: Jean-Marie Seghboyan, MD         
Sub-Investigator: Thomas Signouret, MD         
Hopital Paul Desbief Recruiting
Marseille, France, 13002
Contact: Jérôme Allardet-Servent, MD, MSc    +33491564397    j_allardet@ch-ambroisepare.fr   
Principal Investigator: Jérôme Allardet-Servent, MD,MSc         
Sponsors and Collaborators
Hôpital Européen Marseille
Investigators
Principal Investigator: Jérôme Allardet-Servent, MD,MSc Fondation Hôpital Ambroise Paré
  More Information

No publications provided

Responsible Party: Jerome Allardet-Servent, MD, MD, MSc, Hôpital Européen Marseille
ClinicalTrials.gov Identifier: NCT01090791     History of Changes
Other Study ID Numbers: 2009-A007419-48
Study First Received: March 22, 2010
Last Updated: May 18, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hôpital Européen Marseille:
critically ill patient

Additional relevant MeSH terms:
Critical Illness
Shock
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014