Venous CongestionCoDoRéaNCT04680728
Venous Congestion and Organ Dysfunction.
An observational study of Venous Congestion and Organ Dysfunction Syndrome, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Congestion, Organ Dysfunction Syndrome
- What is being tested?
- collection of biological parameters, collection of echographic parameters and collection of clinical parameters
- How many people
- 185 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2020to 14 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient admitted to intensive care for less than 24 hours
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Venous Congestion and Organ Dysfunction in Intensive Care: a Prospective, Multicenter, Observational Study to Evaluate Prevalence and Risk Factors.
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.
Read more
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.
- Conditions
- Venous Congestion, Organ Dysfunction Syndrome
- Being tested
- collection of biological parameters, collection of echographic parameters, collection of clinical parameters
- Medical subject headings
- Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of biological parametersOther
haemoglobin, haematocrit, sodium, chloraemia, total protein, albumin, L-lactate, pro-BNP, creatinine, uremia, AST, ALT, GGT, ALP, bilirubin, prothrombin time, urinary test if available.
collection of echographic parametersOther
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.
collection of clinical parametersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| patient | Patient admitted to intensive care for less than 24 hours. Receives: Other: collection of biological parameters; Other: collection of echographic parameters; Other: collection of clinical parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
the presence of venous congestion
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start6 Oct 2020
- Primary completion12 Oct 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Venous CongestionStudies 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
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680728
- Sponsor's protocol ID
- GUINOT 2020
- Acronym
- CoDoRéa
- Status last verified
- Jan 2026
- First submitted
- 23 Nov 2020
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 37291662Andrei 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 39686672Guinot 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Congestion and Organ Dysfunction in Intensive Care: a Prospective, Multicenter, Observational Study to Evaluate Prevalence and Risk Factors.
- ClinicalTrials.gov ID
- NCT04680728
- Acronym / sponsor ID
- CoDoRéa / GUINOT 2020
- Conditions
- Venous Congestion, Organ Dysfunction Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 23 Dec 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient | – | Other: collection of biological parameters, Other: collection of echographic parameters, Other: collection of clinical parametersPatient admitted to intensive care for less than 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient admitted to intensive care for less than 24 hours
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Person not affiliated to the national health insurance
- Minor, protected major
- Pregnant or breastfeeding women
- Anechogenicity confirmed by the operator
- Chronic atrial fibrillation
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 |
|---|---|---|
| collection of biological parametershaemoglobin, haematocrit, sodium, chloraemia, total protein, albumin, L-lactate, pro-BNP, creatinine, uremia, AST, ALT, GGT, ALP, bilirubin, prothrombin time, urinary test if available. | Other | patient |
| collection of echographic parametersechocardiography (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. | Other | patient |
| collection of clinical parameterseason 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. | Other | patient |
Primary outcome
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
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 29 Jan 2026.
- Results publication: PubMed 37291662Andrei 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.
- Derived from this study: PubMed 39686672Andrei 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.
- Derived from this study: PubMed 38462160Guinot 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Venous Congestion and Organ Dysfunction Syndrome, run by Centre Hospitalier Universitaire Dijon 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 7 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 29 Jan 2026. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04680728, which also lists 3 linked publications.
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 29 Jan 2026.