FLOTRAC/VIGILEO in Acute Circulatory Failure

Critically Ill Clinical Trial

— FLOVAC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01090791
• Other study ID #: 2009-A007419-48
• Status: Terminated
• Phase: N/A
• First received: March 22, 2010
• Last updated: September 7, 2016
• Start date: May 2011
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Hôpital Européen Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Circulatory Failure
• Critical Illness
• Critically Ill
• Fluid Loading
• Shock

Intervention

Device:
• Flotrac/Vigileo third generation software
Measurement of stroke volume according to the arterial pressure waveform
• Transthoracic echocardiography
Measurement of stroke volume according to the aortic time-velocity integral

Locations

Country	Name	City	State
France	Hopital Ambroise Paré	Marseille
France	Hopital Paul Desbief	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Européen Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke volume measurement between Flotrac/Vigileo device and transthoracic echocardiography	Bland-Altman analysis of the whole SV measurements	30 min	No
Secondary	SV cut-off with Flotrac/Vigileo and with TEE to predict fluid responsiveness	ROC curve	30 min	No
Secondary	SVV cut-off with Flotrac/Vigileo to predict fluid responsiveness	ROC curve	30 min	No