Venous Congestion and Organ Dysfunction.

Completed

• Conditions: Organ Dysfunction Syndrome; Venous Congestion
• Interventions: Other: collection of biological parameters; Other: collection of echographic parameters; Other: collection of clinical parameters

• Registration Number: NCT04680728
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-06
• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-23
• Primary Completion: 2022-10-12
• Status Verified: 2022-11
• Study Completion: 2022-11-14
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient	collection of clinical parameters	Patient admitted to intensive care for less than 24 hours.
patient	collection of biological parameters	Patient admitted to intensive care for less than 24 hours.
patient	collection of echographic parameters	Patient admitted to intensive care for less than 24 hours.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France