Critically IllFLOVACNCT01090791
FLOTRAC/VIGILEO in Acute Circulatory Failure
An observational study of Critically Ill and Acute Circulatory Failure, run by Hôpital Européen Marseille at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Acute Circulatory Failure, Fluid Loading
- What is being tested?
- Flotrac/Vigileo third generation software and Transthoracic echocardiography
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 2 sitesFrance
- Study dates
- May 2011to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients with acute circulatory failure, as defined by two or more of the inclusion criteria.
Who may be able to join
- 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
Who cannot join
- Acute cor pulmonale
- Ongoing renal replacement therapy
- Lack of echogenicity during transthoracic echocardiography
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Paul Desbief
Marseille, 13002
Hopital Ambroise Paré
Marseille, 13006
About this study
Official title: Assessment of the FLOTRAC/VIGILEO Third Generation Software to Predict Fluid Responsiveness in Critically Ill Patient With Acute Circulatory Failure
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
- Being tested
- Flotrac/Vigileo third generation software, Transthoracic echocardiography
- Keywords
- critically ill patient
- Medical subject headings
- Critical Illness, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flotrac/Vigileo third generation softwareDevice
Measurement of stroke volume according to the arterial pressure waveform
Transthoracic echocardiographyDevice
Measurement of stroke volume according to the aortic time-velocity integral
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke volume measurement between Flotrac/Vigileo device and transthoracic echocardiography
Bland-Altman analysis of the whole SV measurements
Measured: 30 min
Secondary outcomes (2)
SV cut-off with Flotrac/Vigileo and with TEE to predict fluid responsiveness
ROC curve
Measured: 30 min
SVV cut-off with Flotrac/Vigileo to predict fluid responsiveness
ROC curve
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startMay 2011
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Major change in protocol anticipated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerome Allardet-Servent, MD, Hôpital Européen Marseille
- Investigators
- Jérôme Allardet-Servent, MD,MSc, Principal investigator, Fondation Hôpital Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090791
- Sponsor's protocol ID
- 2009-A007419-48
- Acronym
- FLOVAC
- Status last verified
- Sep 2016
- First submitted
- 22 Mar 2010
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the FLOTRAC/VIGILEO Third Generation Software to Predict Fluid Responsiveness in Critically Ill Patient With Acute Circulatory Failure
- ClinicalTrials.gov ID
- NCT01090791
- Acronym / sponsor ID
- FLOVAC / 2009-A007419-48
- Conditions
- Critically Ill, Acute Circulatory Failure, Fluid Loading
- Keywords
- critically ill patient
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Major change in protocol anticipated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 23 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with acute circulatory failure, as defined by two or more of the inclusion criteria.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Acute cor pulmonale
- Ongoing renal replacement therapy
- Lack of echogenicity during transthoracic echocardiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flotrac/Vigileo third generation softwareMeasurement of stroke volume according to the arterial pressure waveform | Device | – |
| Transthoracic echocardiographyMeasurement of stroke volume according to the aortic time-velocity integral | Device | – |
Primary outcome
Stroke volume measurement between Flotrac/Vigileo device and transthoracic echocardiography
Time frame: 30 min
Bland-Altman analysis of the whole SV measurements
2 secondary outcomes
SV cut-off with Flotrac/Vigileo and with TEE to predict fluid responsiveness
Time frame: 30 min
SVV cut-off with Flotrac/Vigileo to predict fluid responsiveness
Time frame: 30 min
Results and safety
The study was stopped early (reason given: Major change in protocol anticipated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérôme Allardet-Servent, MD,MSc principal investigator
Fondation Hôpital Ambroise Paré
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill and Acute Circulatory Failure, run by Hôpital Européen Marseille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Major change in protocol anticipated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke volume measurement between Flotrac/Vigileo device and transthoracic echocardiography (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.