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CompletedNCT04680728CoDoRéaUpdated Jan 29, 2026

Venous Congestion and Organ Dysfunction.

An observational study in Venous Congestion and Organ Dysfunction Syndrome, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
185
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Hyperemia with a site in France — 9 open to participants now, 9 under way, none of them phase 3. Hyperemia · France.

Enrollment
2nd of 12
185 · median 82
Started
2020
with 1 other
Observational
12 of 17
6 open now
Registered
5th of 17
by date
Lead sponsor
1 of 17
Centre Hospitalier Universitaire Dijon

Among the 17 studies in Hyperemia with a site in France, this one is the 2nd largest by enrollment of the 12 observational ones, is one of 2 that started in 2020, is one of 12 observational ones, and was the 5th registered.

By phase

17 studies; the count open now beside each. This study's row is marked.

Observationalthis study12 · 6 open
No phase5 · 3 open

By the year they started

First in 2014; this study’s year is marked. 2 started in 2020.

Size and results

Median enrollment 60 across the 5 interventional studies, 82 across the 12 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.

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02

Study summary

Venous congestion, which is a phenomenon described in cardiology and post-operative cardiac surgery, is responsible for an increase in morbidity and mortality.

Indeed, it can lead to kidney failure, liver failure, prolonged ileus, scarring complications, and neurological disorders. Clinical and ultrasound indications have been described to diagnose this condition.

To date, this phenomenon is poorly known and not described in intensive care patients outside the cardiac context. However, intensive care patients can present the risk factors associated with the occurrence of congestion: acute cardiac failure, significant water-salt overload, and/or fluid distribution anomalies. Thus, observational studies have found an association between the input-output balance, the quantity of salt-water intake, the presence of right heart dysfunction and the occurrence of acute kidney failure, digestive disorders, hypoxemia and a prolonged stay in intensive care. The presence of a congestive condition is medically treatable since diuretic decongestion is associated with improved cardiac outcomes.

It is therefore necessary, in an intensive care context, to be able to define and diagnose this state of venous congestion, to study its prevalence, and to confirm the existence of a link with organ failure in order to pave the way to known adapted treatment options.

03

Conditions studied

  • Venous Congestion
  • Organ Dysfunction Syndrome

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patient admitted to intensive care for less than 24 hours

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.

Inclusion criteria

  • Adult
  • Patient who has expressed his or her non-opposition to the collection of data (or the health care proxy, or a close relative if the patien is unable to receive the information)
  • Patient admitted to intensive care for less than 24 hours.

Exclusion criteria

Exclusion Criteria:

  • Person not affiliated to the national health insurance
  • Minor, protected major
  • Pregnant or breastfeeding women
  • Anechogenicity confirmed by the operator
  • Chronic atrial fibrillation
  • Mechanical cardiac assistance
  • Uncontrolled blood pressure (MAP \< 65 mmHg)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
185 participants (actual)
Patient registry
No

Groups and cohorts

  • patient

    Patient admitted to intensive care for less than 24 hours.

    Other: collection of biological parameters · Other: collection of echographic parameters · Other: collection of clinical parameters

Interventions

  • Othercollection of biological parameters

    haemoglobin, haematocrit, sodium, chloraemia, total protein, albumin, L-lactate, pro-BNP, creatinine, uremia, AST, ALT, GGT, ALP, bilirubin, prothrombin time, urinary test if available.

  • Othercollection of echographic parameters

    echocardiography (FEVG, subaortic ITV before and after LJP, cardiac index, MAPSE, mitral flow doppler, RVFAC, FEVD, STDVD, VD/VG ratio, TAPSE, tricuspid S wave, IT with PAPs, tricuspid flow doppler), Doppler of suprahepatic veins (S wave, D wave, S/D ratio), renal doppler (VII, RRI, aspect of venous flow in cortical and hilar), femoral venous doppler, doppler of the portal trunk, diameter of the VCI.

  • Othercollection of clinical parameters

    eason for hospitalisation, co-morbidities, IGS2 score, SOFA, haemodynamic signs (BP, HR, CVP), sinus rhythm or not, temperature, diuresis, weight, input-output assessment, use of dialysis, ventilatory parameters (intubation, mode, FiO2(%), Vt, FR, PEEP, plateau pressure, driving pressure), state of shock (sepsis, postoperative, haemorrhagic, cardiogenic), transfusion (type, number), catecholamines (type, dose, duration), diuretics and dose, clinical criteria of venous congestion (jugular turgidity, hepato-jugular reflux, hepatosplenomegaly, pitting oedemas of the lower limbs, hepatalgia), neurological evaluation (Glasgow Coma Scale, CAM-ICU), time to resume enteral feeding and bowel movements, weight.

06

What researchers measure

Primary outcomes

  1. the presence of venous congestion

    Time frame: From date of inclusion until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 28 day

07

Study locations

1 site
  • Chu Dijon Bourogne
    Dijon, 21000, France
08

References and documents

Publications

  • Andrei S, Bahr PA, Nguyen M, Bouhemad B, Guinot PG. Prevalence of systemic venous congestion assessed by Venous Excess Ultrasound Grading System (VExUS) and association with acute kidney injury in a general ICU cohort: a prospective multicentric study. Crit Care. 2023 Jun 8;27(1):224. doi: 10.1186/s13054-023-04524-4. PubMed 37291662 ↗
  • Andrei S, Longrois D, Nguyen M, Bouhemad B, Guinot PG. Portal vein pulsatility is associated with the cumulative fluid balance: A post hoc longitudinal analysis of a prospective, general intensive care unit cohort. Eur J Anaesthesiol. 2025 Apr 1;42(4):324-331. doi: 10.1097/EJA.0000000000002111. Epub 2024 Dec 16. PubMed 39686672 ↗
  • Guinot PG, Longrois D, Andrei S, Nguyen M, Bouhemad B; CodOrea study group. Exploring congestion endotypes and their distinct clinical outcomes among ICU patients: A post-hoc analysis. Anaesth Crit Care Pain Med. 2024 Jun;43(3):101370. doi: 10.1016/j.accpm.2024.101370. Epub 2024 Mar 8. PubMed 38462160 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2020 to primary completion in Oct 2022, 24 months.

Of 28 observational studies under Hyperemia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 27. This study's 24 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2020
First posted
Dec 23, 2020
StartActual
Oct 6, 2020
Primary completionActual
Oct 12, 2022
CompletionActual
Nov 14, 2022
Last update
Jan 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04680728
Responsible party
Sponsor
First posted
Dec 23, 2020
Start date
Oct 6, 2020
Primary completion
Oct 12, 2022
Completion
Nov 14, 2022
Last update
Jan 29, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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