Venous Congestion and Organ Dysfunction. (CoDoRéa)

January 28, 2026 updated by: Centre Hospitalier Universitaire Dijon

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

185

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • Chu Dijon Bourogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patient admitted to intensive care for less than 24 hours

Description

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:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patient
Patient admitted to intensive care for less than 24 hours.
Other: collection 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.
Other: collection 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.
Other: collection 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2020

Primary Completion (Actual)

October 12, 2022

Study Completion (Actual)

November 14, 2022

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

December 17, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUINOT 2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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