Acute Circulatory FailureRER DNCT02878369
Evaluation of Doppler Flow From the Femoral Artery as a Reflection of Cardiac Flow in a Vascular Fluid Test
An observational study of Acute Circulatory Failure, run by Nantes University Hospital at 1 site in France.
Trial summary
In order to identify the responding patients with vascular filling test, this research aims to compare the performance of the increased flow in the femoral artery to the performance of the blood pressure increase. The reference measurement will increase cardiac output measured by ultrasound. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Circulatory Failure
- What is being tested?
- Doppler measurement of blood flow in the outflow tract of the left ventricle and the femoral artery,Reading blood pressures displayed on the monitor.
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Mar 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: One hundred and twenty adult patients hospitalized in one of the participating ICUs, will be included (see the justification required number of subjects in "statistics") if * They are already carrying an intra-arterial catheter (femoral or radial). * They exhibit acute circulatory failure signs (see below) * The doctor in charge prescribed a vascular fluid replacement, regardless of the purposes of the study: * vascular fluid replacement * initiation or catecholamine * or increase (> 10%) of catecholamine dosage.
Who may be able to join
- Patient hospitalized in intensive care and affiliated to a social security system
- Intra-arterial catheter already in place and operational
- Stability blood pressure for 5 min (no change in mean arterial pressure> 10%, no increase in dose catecholamine)
- Presence of at least one sign of acute circulatory failure from:
- Low blood pressure (mean arterial pressure <65 mmHg and / or systolic <90 mmHg)
- tachycardia> 120 bpm without other obvious cause a circulatory failure
Show all 18Show fewer
- Oliguria <1 ml / kg during the last hour suggestive of circulatory failure
- blood Hyperlactataemia> 2 mmol / l without other obvious cause a systemic circulatory failure (lactate will not be measured for the purposes of the study)
- Smear
- ongoing catecholamine Administration
- Another sign justifying, according to the doctor in charge, vascular filling test (capillary refill time elongated, others ...)
- The doctor in charge has prescribed a fluid loading test, regardless of the needs of the study.
- Non inclusion criteria:
- Clear contraindication to the femoral artery Doppler (wound or burn the groin, for example)
- Complete occlusion of the femoral artery or 2 of the aorta requiring or having required a vascular bypass
- Pregnant woman
- Minor
- Major Trust
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Karim LAKHAL, Dr contact
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, 44000
Karim Lakhal, Dr, lakhal_karim@yahoo.fr
About this study
In order to identify the responding patients with vascular filling test, this research aims to compare the performance of the increased flow in the femoral artery to the performance of the blood pressure increase.
The reference measurement will increase cardiac output measured by ultrasound.
Read the detailed description
It is notable that in the intensive care patient, the ultrasound measurement of cardiac flow is not always possible, especially in case of mechanical ventilation, often responsible for air interposed between the ultrasound probe and the heart, thus stopping the ultrasound. Use the blood pressure increase as a reflection of the increase in cardiac flow induced by fluid replacement is not a fully satisfactory alternative since its performance is at best just acceptable.
Flow measurement in the femoral artery could be an attractive alternative to the cardiac output measurement as:
- It is easy: the femoral vascular ultrasound is booming with resuscitators, including the laying of intravascular catheter or thrombosis diagnosis.
- It is painless: it is based on the application of the ultrasound probe on the root of the thigh for less than 5 minutes.
- It is not subject to limitations echogenicity by interposition of air (except in exceptional circumstances)
- It measures the same physiological parameter (arterial flow) as measuring ultrasound cardiac output (based on measurement of the flow at the outflow tract of the left ventricle).
Pathophysiology study, multicenter (conducted in three French ICUs), open, prospective in order to evaluate the flow doppler from the femoral artery as a reflection of cardiac flow in a vascular fluid test in patient with signs of acute circulatory failure in intensive care unit.
- Conditions
- Acute Circulatory Failure
- Being tested
- Doppler measurement of blood flow in the outflow tract of the left ventricle and the femoral artery,Reading blood pressures displayed on the monitor.
- Keywords
- fluid replacement
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler measurement of blood flow in the outflow tract of the left ventricle and the femoral artery,Reading blood pressures displayed on the monitor.Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
In the intensive care patient of acute circulatory failure signs, assess the increase of the femoral arterial flow (specifically its full-time speed, ΔRVAFitv measured by Doppler ultrasound) to identify responders this fluid replacement.
Measured: First patient enrollment: april 2014 - Study duration: 24 month - Patient follow-up: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startApr 2014
- Primary completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Circulatory FailureStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878369
- Sponsor's protocol ID
- RC13_0486
- Acronym
- RER D
- Status last verified
- Aug 2016
- First submitted
- 22 Aug 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Doppler Flow From the Femoral Artery as a Reflection of Cardiac Flow in a Vascular Fluid Test
- ClinicalTrials.gov ID
- NCT02878369
- Acronym / sponsor ID
- RER D / RC13_0486
- Conditions
- Acute Circulatory Failure
- Keywords
- fluid replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (actual)
- First posted
- 25 Aug 2016 (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.
In order to identify the responding patients with vascular filling test, this research aims to compare the performance of the increased flow in the femoral artery to the performance of the blood pressure increase.
The reference measurement will increase cardiac output measured by ultrasound.
Detailed description
It is notable that in the intensive care patient, the ultrasound measurement of cardiac flow is not always possible, especially in case of mechanical ventilation, often responsible for air interposed between the ultrasound probe and the heart, thus stopping the ultrasound. Use the blood pressure increase as a reflection of the increase in cardiac flow induced by fluid replacement is not a fully satisfactory alternative since its performance is at best just acceptable.
Flow measurement in the femoral artery could be an attractive alternative to the cardiac output measurement as:
- It is easy: the femoral vascular ultrasound is booming with resuscitators, including the laying of intravascular catheter or thrombosis diagnosis.
- It is painless: it is based on the application of the ultrasound probe on the root of the thigh for less than 5 minutes.
- It is not subject to limitations echogenicity by interposition of air (except in exceptional circumstances)
- It measures the same physiological parameter (arterial flow) as measuring ultrasound cardiac output (based on measurement of the flow at the outflow tract of the left ventricle).
Pathophysiology study, multicenter (conducted in three French ICUs), open, prospective in order to evaluate the flow doppler from the femoral artery as a reflection of cardiac flow in a vascular fluid test in patient with signs of acute circulatory failure in intensive care unit.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- One hundred and twenty adult patients hospitalized in one of the participating ICUs, will be included (see the justification required number of subjects in "statistics") if * They are already carrying an intra-arterial catheter (femoral or radial). * They exhibit acute circulatory failure signs (see below) * The doctor in charge prescribed a vascular fluid replacement, regardless of the purposes of the study: * vascular fluid replacement * initiation or catecholamine * or increase (> 10%) of catecholamine dosage.
Key inclusion criteria (18 listed)
- Patient hospitalized in intensive care and affiliated to a social security system
- Intra-arterial catheter already in place and operational
- Stability blood pressure for 5 min (no change in mean arterial pressure> 10%, no increase in dose catecholamine)
- Presence of at least one sign of acute circulatory failure from:
- The doctor in charge has prescribed a fluid loading test, regardless of the needs of the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Doppler measurement of blood flow in the outflow tract of the left ventricle and the femoral artery,Reading blood pressures displayed on the monitor. | Procedure or surgery | – |
Primary outcome
In the intensive care patient of acute circulatory failure signs, assess the increase of the femoral arterial flow (specifically its full-time speed, ΔRVAFitv measured by Doppler ultrasound) to identify responders this fluid replacement.
Time frame: First patient enrollment: april 2014 - Study duration: 24 month - Patient follow-up: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 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.
Karim LAKHAL, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Circulatory Failure, run by Nantes University Hospital at 1 site 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 18 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karim LAKHAL, Dr (lakhal_karim@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In the intensive care patient of acute circulatory failure signs, assess the increase of the femoral arterial flow (specifically its full-time speed, ΔRVAFitv measured by Doppler ultrasound) to identify responders this fluid replacement. (time frame: First patient enrollment: april 2014 - Study duration: 24 month - Patient follow-up: 30 minutes). 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 25 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.