Inferior Vena Cava AbnormalityTHEFRACSNCT04914455
Transhepatic Echography for Fluid Responsiveness After Cardiovascular Surgery
An observational study of Inferior Vena Cava Abnormality and Fluid Responsiveness, run by University Hospital, Lille at 1 site in France.
Trial summary
Fluid expansion in critically ill patients following high risk surgery may induce fluid overload and worse outcome. Several tools have been developped to predict fluid responsiveness in such situation in order to avoid inappropriate fluid administration but with several limitations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inferior Vena Cava Abnormality, Fluid Responsiveness, Fluid Overload
- What is being tested?
- Echocardiography and transhepatic inferior vena cava assessment using ultrasound.
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2020to 4 Jun 2021
- 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: Patients admitted to our intensive care unit following cardiac surgery or aortic surgery, under mechanical ventilation or not.
Who may be able to join
- High risk cardiovascular surgery patients admitted in ICU
- With transhepatic IVC and stroke volume measurement feasible.
- Informed consent
Who cannot join
- Righ ventricle failure
- Significant tricuspid regurgitation
- Tamponade
- Severe hypoxemia
- Age <18 ans
- No health care coverage
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille
Lille, NORD, 59000
About this study
Official title: Performance of Static and Dynamic Accessment of Inferior Vena Cava Diameter for the Diagnosis of Fluid Responsiveness
Fluid expansion in critically ill patients following high risk surgery may induce fluid overload and worse outcome. Several tools have been developped to predict fluid responsiveness in such situation in order to avoid inappropriate fluid administration but with several limitations. Inferior vena cava (IVC) distensibility is one of those tools which has the advantage to be non-invasive, dynamic and safe, is usually measured by subcostal (SC)approach. In post surgical setting this acess is limited du to practical reasons (scar, dressing...), therefore a transhepatic (TH) approach is used but has not been validated as a fluid responsiveness prediction tool. The correlation between SC approach with the TH approach vary according to studies. Therefore the performances, the threshold identified for SC approach can not be translated to the TH approach. Further, fluid congestion status measured before IVC analyses, may be a useful confounder and safety endpoint for fluid responsiveness interpretation.
The primary objective of this study is therefore to study the performance of the IVC measured using TH approach (IVCth) in predicting of fluid responsiveness defined as an increased of 10% and over of stroke volume.
Secondary objectives intend to analyse the correlation between TH and SC approaches, to compared their performances for fluid responsiveness prediction, and to analyse the weight of venous congestion on fluid responsiveness prediction.
Read the detailed description
Inappropriate volume expansion in the critically ill patient may leads to an increase in fluid balance, fluid overload and worse outcome. This increase in fluid balance is associated with a poor prognosis in the ICU patients, especially after cardiac surgery and high risk surgery .
Generally, the primary objective of an adequate volume expansion is a significant increase in stroke volume called fluid responsiveness (> 10% of increase). This increase in cardiac output promotes tissue perfusion, thus avoiding the occurrence of organ dysfunction.
The identification of fluid responsiveness in these patients is thus a cardinal element of haemodynamic management in intensive care. Among the non-invasive tools to assess this fluid responsiveness, the assessment of the ventilatory or forced inspiration distensibility of the inferior vena cava (IVC) has been proposed with convincing results in several clinical studies. However with various diagnostic performances and threshold.
The measurement of the diameter of the IVC is classically performed via the subcostal (SC) or subxiphoid approach. However, this approach is not always easily accessible in intensive care patients, particularly after cardiovascular surgery or laparotomy, due to practical constraints (algic scars, dressings, prone position). The transhepatic approach (TH) is a technically feasible approach in such cases. However, it has little validation in the literature, particularly in its ability to predict response to volume expansion. knowing that the correlation between the SC approach with the TH approach varies according to studies, the performance and the threshold identified for SC approach can not be translated into that of the TH approach. Further, fluid congestion status measured before IVC analyses, may be a useful confounder and safety endpoint for fluid responsiveness interpretation.
- Conditions
- Inferior Vena Cava Abnormality, Fluid Responsiveness, Fluid Overload, Venous Congestion, Cardiovascular Surgery
- Being tested
- Echocardiography and transhepatic inferior vena cava assessment using ultrasound.
- Keywords
- Inferior vena cava distensibility, Transhepatic inferior vena cava distensibility, Ultrasound diagnoses
- Medical subject headings
- Edema, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography and transhepatic inferior vena cava assessment using ultrasound.Diagnostic test
Also called Venous congestion using ultrasound
For all participant :
- Inferior vena cava diameter will be measure before and after fluid expansion 'which administration will be decided by a physician other that the investigator).
- Stroke volume using primarily VTI in TTE or a cardiac output monitoring device (Swan ganz catheter (Edwards life science), EV 1000 (edwards life science), PiCCO(Getinge))
- Absence of significant pericardial effusion of hematoma
Whenever possible:
Subcostal measurement of IVC, ejection fraction, cardiac outcput, mitral E, A and E' waves, TAPSE, tricupid S' wave, Right ventricle fractional area change.
venous congestion assesment : hepatic vein, portal vein and renal vein Doppler to define the VEXUS Score;
| Study group | Role | What they receive |
|---|---|---|
| Fluid responsiveness groups (responders and non-responders) | Fluid responsiveness is defined as an increase in stroke volume of 10% and more form baseline. Receives: Diagnostic Test: Echocardiography and transhepatic inferior vena cava assessment using ultrasound. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid responsiveness
An increase in stroke volume of 10% and more, following fluid bolus of 250 to 500 ml of cristalloid or colloid.
Measured: Measurement performs before and after fluid bolus (during the 10 min following the end of fluid bolus).
Secondary outcomes (1)
Venous congestion
Venous congestion is defined using the VEXUS Score after sub hepatic, portal and renal veins Doppler.
Measured: during the 15 minutes following the end of the fluid bolus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start8 Dec 2020
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Vena Cava AbnormalityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mouhamed MOUSSA, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914455
- Sponsor's protocol ID
- 2019_17
- Other IDs
- 2019_17 2019-A02724-53
- Acronym
- THEFRACS
- Status last verified
- Dec 2025
- First submitted
- 2 Jun 2021
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Static and Dynamic Accessment of Inferior Vena Cava Diameter for the Diagnosis of Fluid Responsiveness
- ClinicalTrials.gov ID
- NCT04914455
- Acronym / sponsor ID
- THEFRACS / 2019_17
- Conditions
- Inferior Vena Cava Abnormality, Fluid Responsiveness, Fluid Overload, Venous Congestion, Cardiovascular Surgery
- Keywords
- Inferior vena cava distensibility, Transhepatic inferior vena cava distensibility, Ultrasound diagnoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 4 Jun 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.
Fluid expansion in critically ill patients following high risk surgery may induce fluid overload and worse outcome. Several tools have been developped to predict fluid responsiveness in such situation in order to avoid inappropriate fluid administration but with several limitations. Inferior vena cava (IVC) distensibility is one of those tools which has the advantage to be non-invasive, dynamic and safe, is usually measured by subcostal (SC)approach. In post surgical setting this acess is limited du to practical reasons (scar, dressing...), therefore a transhepatic (TH) approach is used but has not been validated as a fluid responsiveness prediction tool. The correlation between SC approach with the TH approach vary according to studies. Therefore the performances, the threshold identified for SC approach can not be translated to the TH approach. Further, fluid congestion status measured before IVC analyses, may be a useful confounder and safety endpoint for fluid responsiveness interpretation.
The primary objective of this study is therefore to study the performance of the IVC measured using TH approach (IVCth) in predicting of fluid responsiveness defined as an increased of 10% and over of stroke volume.
Secondary objectives intend to analyse the correlation between TH and SC approaches, to compared their performances for fluid responsiveness prediction, and to analyse the weight of venous congestion on fluid responsiveness prediction.
Detailed description
Inappropriate volume expansion in the critically ill patient may leads to an increase in fluid balance, fluid overload and worse outcome. This increase in fluid balance is associated with a poor prognosis in the ICU patients, especially after cardiac surgery and high risk surgery .
Generally, the primary objective of an adequate volume expansion is a significant increase in stroke volume called fluid responsiveness (> 10% of increase). This increase in cardiac output promotes tissue perfusion, thus avoiding the occurrence of organ dysfunction.
The identification of fluid responsiveness in these patients is thus a cardinal element of haemodynamic management in intensive care. Among the non-invasive tools to assess this fluid responsiveness, the assessment of the ventilatory or forced inspiration distensibility of the inferior vena cava (IVC) has been proposed with convincing results in several clinical studies. However with various diagnostic performances and threshold.
The measurement of the diameter of the IVC is classically performed via the subcostal (SC) or subxiphoid approach. However, this approach is not always easily accessible in intensive care patients, particularly after cardiovascular surgery or laparotomy, due to practical constraints (algic scars, dressings, prone position). The transhepatic approach (TH) is a technically feasible approach in such cases. However, it has little validation in the literature, particularly in its ability to predict response to volume expansion. knowing that the correlation between the SC approach with the TH approach varies according to studies, the performance and the threshold identified for SC approach can not be translated into that of the TH approach. Further, fluid congestion status measured before IVC analyses, may be a useful confounder and safety endpoint for fluid responsiveness interpretation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluid responsiveness groups (responders and non-responders) | – | Diagnostic Test: Echocardiography and transhepatic inferior vena cava assessment using ultrasound.Fluid responsiveness is defined as an increase in stroke volume of 10% and more form baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to our intensive care unit following cardiac surgery or aortic surgery, under mechanical ventilation or not.
Key inclusion criteria (3 listed)
- High risk cardiovascular surgery patients admitted in ICU
- With transhepatic IVC and stroke volume measurement feasible.
- Informed consent
Key exclusion criteria (6 listed)
- Righ ventricle failure
- Significant tricuspid regurgitation
- Tamponade
- Severe hypoxemia
- Age <18 ans
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 |
|---|---|---|
| Echocardiography and transhepatic inferior vena cava assessment using ultrasound.Also: Venous congestion using ultrasoundFor all participant : * Inferior vena cava diameter will be measure before and after fluid expansion 'which administration will be decided by a physician other that the investigator). * Stroke volume using primarily VTI in TTE or a cardiac output monitoring device (Swan ganz catheter (Edwards life science), EV 1000 (edwards life science), PiCCO(Getinge)) * Absence of significant pericardial effusion of hematoma Whenever possible: Subcostal measurement of IVC, ejection fraction, cardiac outcput, mitral E, A and E' waves, TAPSE, tricupid S' wave, Right ventricle fractional area change. venous congestion assesment : hepatic vein, portal vein and renal vein Doppler to define the VEXUS Score; | Diagnostic test | Fluid responsiveness groups (responders and non-responders) |
Primary outcome
Fluid responsiveness
Time frame: Measurement performs before and after fluid bolus (during the 10 min following the end of fluid bolus).
An increase in stroke volume of 10% and more, following fluid bolus of 250 to 500 ml of cristalloid or colloid.
1 secondary outcome
Venous congestion
Time frame: during the 15 minutes following the end of the fluid bolus
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 23 Dec 2025.
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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.
Mouhamed MOUSSA, MD principal investigator
University Hospital, Lille
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 Inferior Vena Cava Abnormality and Fluid Responsiveness, run by University Hospital, Lille 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 3 inclusion and 6 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 23 Dec 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?
Fluid responsiveness (time frame: Measurement performs before and after fluid bolus (during the 10 min following the end of fluid bolus).). 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 23 Dec 2025.