FLOTRAC/VIGILEO in Acute Circulatory Failure

Terminated

• Conditions: Critically Ill; Fluid Loading; Acute Circulatory Failure

• Registration Number: NCT01090791
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-22
• Study First Submitted QC: 2010-03-22
• Study First Posted: 2010-03-23
• Study Start: 2011-05
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stroke volume measurement between Flotrac/Vigileo device and transthoracic echocardiography	30 min	Bland-Altman analysis of the whole SV measurements

Secondary Outcome Measures

Name	Time	Method
SVV cut-off with Flotrac/Vigileo to predict fluid responsiveness	30 min	ROC curve
SV cut-off with Flotrac/Vigileo and with TEE to predict fluid responsiveness	30 min	ROC curve

Trial Locations

Locations (2)

Hopital Paul Desbief; 🇫🇷 Marseille, France

Hopital Ambroise Paré; 🇫🇷 Marseille, France