Acute Circulatory FailureVSC MIRNCT04946643
Subclavian Vein Diameter Variations to Assess Vascular Filling
An observational study of Acute Circulatory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Haemodynamic optimisation is a fundamental step and a daily issue in the management of intensive care patients with acute circulatory failure. Failure to optimise haemodynamics is recognised as a factor associated with morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Circulatory Failure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2021to 21 Jul 2022
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age over 18 years, Acute circulatory failure from any cause defined as low blood pressure (systolic blood pressure less than 90mmHg and/or mean arterial pressure less than 65mmHg) and/or marbling and mechanical ventilation, affiliation with a social security scheme or entitled to it, information and non-objection of the patient to participate in the research.
Who may be able to join
- Age over 18 years;
- Acute circulatory failure from any cause defined as low blood pressure (systolic blood pressure less than 90mmHg and/or mean arterial pressure less than 65mmHg) and/or marbling and mechanical ventilation;
- Affiliation with a social security scheme or entitled to it;
- Information and non-objection of the patient to participate in the research.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site
Intensive care unit, Ambroise Paré hospital, APHP
Boulogne-Billancourt, 92100
About this study
Official title: Contribution of Subclavian Vein Diameter Variations to Assess Vascular Filling Among Critical Care Patients
Haemodynamic optimisation is a fundamental step and a daily issue in the management of intensive care patients with acute circulatory failure. Failure to optimise haemodynamics is recognised as a factor associated with morbidity and mortality.
Although the first line of treatment is often vascular filling, many studies have found that excessive vascular filling alone is deleterious and leads to increased morbidity and mortality due to pulmonary and interstitial oedema. The use of catecholamines avoids this undue vascular filling.
Read more
At present, the therapeutic strategy in acute circulatory failure is to perform a personalised "titrated" vascular filling after assessing the need for it.
To do this, predictive criteria for the need to continue vascular filling in order to optimise cardiac output and tissue perfusion pressure, particularly by ultrasound, have been developed, notably by transesophageal approach.
It also appeared to us that offering an alternative to the transesophageal approach would reduce invasiveness on the one hand, but would also offer an alternative when the transesophageal approach is contraindicated.
Read the detailed description
Acute circulatory failure is encountered in shock, regardless of its origin, when physiological compensatory mechanisms are overwhelmed. The initial tachycardia and reflex vasoconstriction of shock aims to maintain sufficient arterial pressure and tissue perfusion pressure. Beyond these mechanisms of compensation for relative and/or absolute hypovolaemia, arterial hypotension and tissue hypoperfusion appear, expressed clinically by functional signs (e.g. asthenia) and physical signs (arterial hypotension, consciousness disorders, mottling, oliguria, etc.).
It has been observed that organ failure induced by circulatory insufficiency is associated with a poor prognosis in septic shock. In daily clinical practice, acute circulatory failure is most often characterised by haemodynamic failure as reflected by arterial hypotension and/or tachycardia. Early treatment of acute circulatory failure is a recognised prognostic factor in trauma patients and patients with septic shock (2,3), leading to a reduction in mortality.
The first line of treatment for circulatory failure is usually early vascular filling due to relative and absolute hypovolaemia. The choice of fluids depends on the clinical situation, although for septic shock crystalloids are recommended as first-line therapy. Although early vascular filling is the first line of treatment, overfilling, also known as "induced" vascular filling, is alone recognised as a factor associated with excess mortality in various situations of acute circulatory failure. It is now accepted that early administration of inotropic and/or vasopressor agents, i.e. before the end of vascular filling, is necessary to restore arterial pressure and therefore limit the consequences of tissue hypo perfusion. In order to determine the choice between continued vascular filling and the administration of vasopressor and/or inotropic agents, predictive indicators of vascular filling requirements have been developed. These aim to determine whether or not vascular filling will increase cardiac output or one of its surrogates such as the subaortic time velocity integral (SATI).
Numerous indicators have been described for more than 30 years in intensive care units. Dynamic criteria are those that have the best predictive performance compared to static indicators. Their time-consuming implementation requires an invasive approach for most of these criteria due to their technical nature and the need to respect sometimes restrictive validity criteria.
The technological development of ultrasound scanners has allowed their liberal use and the validation of dynamic ultrasound criteria predictive of the response to vascular filling (respiratory variations of the sub-aortic velocity time integral, S wave, index of distensibility of the inferior vena cava, index of collapsibility of the superior vena cava, central venous pressure). The mechanism underlying superior vena cava collapsibility is complex, involving variations in intra-thoracic pressure as well as the inherent movements of the lung parenchyma. These pathophysiological mechanisms have not yet been described.
A recent study has demonstrated the interchangeability between delta PP and respiratory variations in subclavian vein diameter in intensive care patients and in the operating theatre.
The advantages of the transthoracic ultrasound approach to assessing respiratory variations in subclavian vein diameter are its rapidity of implementation, ease of use, non-invasive nature and reproducibility.
- Conditions
- Acute Circulatory Failure
- Keywords
- acute circulatory failure, intensive care unit, echocardiography, superior and inferior vena cava
- Medical subject headings
- Shock
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory variations of subclavian vein diameter
Correlation between respiratory variations in subclavian vein (SCV) diameter with cardiac output assessed by measuring respiratory variations in the subaortic velocity time integral
Measured: at 5 minutes
Secondary outcomes (1)
Collapsibility index of the superior vena cava
Correlation between respiratory variations in subclavian vein (SCV) diameter and collapsibility index of the superior vena cava assessed by trans thoracic and trans oesophageal approach.
Measured: at 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start27 Jul 2021
- Primary completion21 Jul 2022
- Study completion21 Jul 2022
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 Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain Jouffroy, MD, PhD, Principal investigator, Intensive care unit, Ambroise Paré hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946643
- Sponsor's protocol ID
- APHP210513
- Other IDs
- 2021-A00694-37
- Acronym
- VSC MIR
- Status last verified
- Apr 2025
- First submitted
- 21 Jun 2021
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Subclavian Vein Diameter Variations to Assess Vascular Filling Among Critical Care Patients
- ClinicalTrials.gov ID
- NCT04946643
- Acronym / sponsor ID
- VSC MIR / APHP210513
- Conditions
- Acute Circulatory Failure
- Keywords
- acute circulatory failure, intensive care unit, echocardiography, superior and inferior vena cava
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 1 Jul 2021 (actual)
- 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.
Haemodynamic optimisation is a fundamental step and a daily issue in the management of intensive care patients with acute circulatory failure. Failure to optimise haemodynamics is recognised as a factor associated with morbidity and mortality.
Although the first line of treatment is often vascular filling, many studies have found that excessive vascular filling alone is deleterious and leads to increased morbidity and mortality due to pulmonary and interstitial oedema. The use of catecholamines avoids this undue vascular filling.
At present, the therapeutic strategy in acute circulatory failure is to perform a personalised "titrated" vascular filling after assessing the need for it.
To do this, predictive criteria for the need to continue vascular filling in order to optimise cardiac output and tissue perfusion pressure, particularly by ultrasound, have been developed, notably by transesophageal approach.
It also appeared to us that offering an alternative to the transesophageal approach would reduce invasiveness on the one hand, but would also offer an alternative when the transesophageal approach is contraindicated.
Detailed description
Acute circulatory failure is encountered in shock, regardless of its origin, when physiological compensatory mechanisms are overwhelmed. The initial tachycardia and reflex vasoconstriction of shock aims to maintain sufficient arterial pressure and tissue perfusion pressure. Beyond these mechanisms of compensation for relative and/or absolute hypovolaemia, arterial hypotension and tissue hypoperfusion appear, expressed clinically by functional signs (e.g. asthenia) and physical signs (arterial hypotension, consciousness disorders, mottling, oliguria, etc.).
It has been observed that organ failure induced by circulatory insufficiency is associated with a poor prognosis in septic shock. In daily clinical practice, acute circulatory failure is most often characterised by haemodynamic failure as reflected by arterial hypotension and/or tachycardia. Early treatment of acute circulatory failure is a recognised prognostic factor in trauma patients and patients with septic shock (2,3), leading to a reduction in mortality.
The first line of treatment for circulatory failure is usually early vascular filling due to relative and absolute hypovolaemia. The choice of fluids depends on the clinical situation, although for septic shock crystalloids are recommended as first-line therapy. Although early vascular filling is the first line of treatment, overfilling, also known as "induced" vascular filling, is alone recognised as a factor associated with excess mortality in various situations of acute circulatory failure. It is now accepted that early administration of inotropic and/or vasopressor agents, i.e. before the end of vascular filling, is necessary to restore arterial pressure and therefore limit the consequences of tissue hypo perfusion. In order to determine the choice between continued vascular filling and the administration of vasopressor and/or inotropic agents, predictive indicators of vascular filling requirements have been developed. These aim to determine whether or not vascular filling will increase cardiac output or one of its surrogates such as the subaortic time velocity integral (SATI).
Numerous indicators have been described for more than 30 years in intensive care units. Dynamic criteria are those that have the best predictive performance compared to static indicators. Their time-consuming implementation requires an invasive approach for most of these criteria due to their technical nature and the need to respect sometimes restrictive validity criteria.
The technological development of ultrasound scanners has allowed their liberal use and the validation of dynamic ultrasound criteria predictive of the response to vascular filling (respiratory variations of the sub-aortic velocity time integral, S wave, index of distensibility of the inferior vena cava, index of collapsibility of the superior vena cava, central venous pressure). The mechanism underlying superior vena cava collapsibility is complex, involving variations in intra-thoracic pressure as well as the inherent movements of the lung parenchyma. These pathophysiological mechanisms have not yet been described.
A recent study has demonstrated the interchangeability between delta PP and respiratory variations in subclavian vein diameter in intensive care patients and in the operating theatre.
The advantages of the transthoracic ultrasound approach to assessing respiratory variations in subclavian vein diameter are its rapidity of implementation, ease of use, non-invasive nature and reproducibility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age over 18 years, Acute circulatory failure from any cause defined as low blood pressure (systolic blood pressure less than 90mmHg and/or mean arterial pressure less than 65mmHg) and/or marbling and mechanical ventilation, affiliation with a social security scheme or entitled to it, information and non-objection of the patient to participate in the research.
Key inclusion criteria (4 listed)
- Age over 18 years;
- Acute circulatory failure from any cause defined as low blood pressure (systolic blood pressure less than 90mmHg and/or mean arterial pressure less than 65mmHg) and/or marbling and mechanical ventilation;
- Affiliation with a social security scheme or entitled to it;
- Information and non-objection of the patient to participate in the research.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory variations of subclavian vein diameter
Time frame: at 5 minutes
Correlation between respiratory variations in subclavian vein (SCV) diameter with cardiac output assessed by measuring respiratory variations in the subaortic velocity time integral
1 secondary outcome
Collapsibility index of the superior vena cava
Time frame: at 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Romain Jouffroy, MD, PhD principal investigator
Intensive care unit, Ambroise Paré hospital, APHP
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 Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 27 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Respiratory variations of subclavian vein diameter (time frame: at 5 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 27 Apr 2025.