An observational study in Inferior Vena Cava Abnormality, Fluid Responsiveness and Fluid Overload, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by University Hospital, Lille · Observational
Among 35 studies in Edema with a site in France — 6 open to participants now, 6 under way, none of them phase 3. Edema · France.
Among the 35 studies in Edema with a site in France, this one is the 15th largest by enrollment of the 19 observational ones, is one of 3 that started in 2020, is one of 19 observational ones, and was the 24th registered.
566 studies on the registry are indexed under Edema; 95 are open to participants now.
This study's enrollment of 40 is below the median of 67 across 143 observational studies indexed under Edema.
Browse Edema studies →6 of the 35 studies in Edema with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 56 Edema studies recruiting now, 34 (61%) set no upper age limit and 16 (29%) stop at 75 or younger; 8 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →35 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 3 started in 2020.
Median enrollment 138 across the 16 interventional studies, 60 across the 19 observational. Of the 21 that completed or were terminated, 2 (10%) have results posted.
4 of 35 have an industry lead sponsor. The 10 most frequent:
University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
University Hospital, Lille has 2 studies filed under Edema — fewer than ten, so there is no comparison to draw.
3 of the studies in Edema with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06823115Indiana UniversityAssessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0 | 2027-01 |
| NCT07077772Centre Hospitalier Universitaire, AmiensNatriuresis-guided Depletion After Cardiac Surgery | 2027-10 |
| NCT06799299CHU de ReimsCollapsibility Index of the Inferior Vena Cava and Kidney Transplantation | 2027-11-01 |
Among the 35 studies in Edema with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Patients admitted to our intensive care unit following cardiac surgery or aortic surgery, under mechanical ventilation or not.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fluid responsiveness is defined as an increase in stroke volume of 10% and more form baseline.
Diagnostic Test: Echocardiography and transhepatic inferior vena cava assessment 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;
Also known as: Venous congestion using ultrasound
Fluid responsiveness
An increase in stroke volume of 10% and more, following fluid bolus of 250 to 500 ml of cristalloid or colloid.
Time frame: Measurement performs before and after fluid bolus (during the 10 min following the end of fluid bolus).
Venous congestion
Venous congestion is defined using the VEXUS Score after sub hepatic, portal and renal veins Doppler.
Time frame: during the 15 minutes following the end of the fluid bolus
Ran from Dec 2020 to primary completion in Jun 2021, 5 months.
Of 76 non-industry observational studies under Edema, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's 5 months is below that.
Counting every sponsor, half of 85 studies reached it within 23 months; a quarter within 7 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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