Venous Congestion and Organ Dysfunction.

NCT04680728 | Completed

• 1 other identifier: GUINOT 2020
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Organ Dysfunction Syndrome; Venous Congestion

Outcome Measures

Primary Outcomes (1)

• the presence of venous congestion

  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

Study Arms (1)

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

collection of biological parameters OTHER

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

patient

collection of echographic parameters OTHER

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.

patient

collection of clinical parameters OTHER

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.

patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient admitted to intensive care for less than 24 hours

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Related Publications (3)

• 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.

  PMID: 37291662 RESULT

• 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.

  PMID: 39686672 DERIVED

• 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.

  PMID: 38462160 DERIVED

MeSH Terms

Conditions

Hyperemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 23, 2020
• Study Start: October 6, 2020
• Primary Completion: October 12, 2022
• Study Completion: November 14, 2022
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

FR (1)