FLOTRAC/VIGILEO in Acute Circulatory Failure

NCT ID: NCT01090791

Last Updated: 2016-09-08

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2016-09-30

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

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Interventions

Flotrac/Vigileo third generation software

Measurement of stroke volume according to the arterial pressure waveform

Intervention Type: DEVICE

Transthoracic echocardiography

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Européen Marseille

OTHER

Sponsor Role: lead

Responsible Party

Jerome Allardet-Servent, MD

MD, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jérôme Allardet-Servent, MD,MSc

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Ambroise Paré

Locations

Hopital Paul Desbief

Marseille, , France

Hopital Ambroise Paré

Marseille, , France

Countries

France

Other Identifiers

2009-A007419-48

Identifier Type: -

Identifier Source: org_study_id