FLOTRAC/VIGILEO in Acute Circulatory Failure

NCT01090791 | Terminated

• 1 other identifier: 2009-A007419-48
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Critically Ill; Acute Circulatory Failure; Fluid Loading

Keywords

critically ill patient

Outcome Measures

Primary Outcomes (1)

• Stroke volume measurement between Flotrac/Vigileo device and transthoracic echocardiography

  Bland-Altman analysis of the whole SV measurements

  30 min

Secondary Outcomes (2)

• SV cut-off with Flotrac/Vigileo and with TEE to predict fluid responsiveness

  30 min

• SVV cut-off with Flotrac/Vigileo to predict fluid responsiveness

  30 min

Interventions

Flotrac/Vigileo third generation software DEVICE

Measurement of stroke volume according to the arterial pressure waveform

Transthoracic echocardiography DEVICE

Measurement of stroke volume according to the aortic time-velocity integral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients with acute circulatory failure, as defined by two or more of the inclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• Acute cor pulmonale
• Ongoing renal replacement therapy
• Lack of echogenicity during transthoracic echocardiography

Sponsors & Collaborators

• Hôpital Européen Marseille: lead

Study Sites (2)

Hopital Paul Desbief

Marseille, 13002, France

Location

Hopital Ambroise Paré

Marseille, 13006, France

Location

MeSH Terms

Conditions

Critical Illness; Shock

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Jérôme Allardet-Servent, MD,MSc

  Fondation Hôpital Ambroise Paré

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: March 23, 2010
• Study Start: May 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 8, 2016

Record last verified: 2016-09

Locations

FR (2)