Hepatic Doppler to Assess Venous Congestion During Invasive Mechanical Ventilation (DOHECOV)

NCT06914336 | Recruiting

• 1 other identifier: 29BRC25.0048 - DOHECOV
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate venous congestion using hepatic vein doppler for ICU patients with invasive mechanical ventilastion. The primary outcome is the systolic to diastolic hepatic vein velocity ratio S/D . The objective is to find a significant association between S/D and different congestion indicators.

Conditions

Congestion, Venous

Outcome Measures

Primary Outcomes (1)

• Systolic to diastolic hepatic vein velocity ratio S/D

  Relate S/D ratio to clinical data on venous congestion: input/output balance, weight variation, renal insufficiency, diuresis, edema.

  24 hours after intubation and after every 48 hours until extubation up to 12 weeks

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

Patients were included if they were intubated for more than 24 hours. Patients were excluded if they had chronic end-stage renal disease on admission, atrial fibrillation, cirrhosis, portal thrombosisrefusal to participate, whose non-opposition could not be obtained from themselves or their trusted support person in the event of incapacity or if they were under legal protection. S/D velocity ratio was measured as well as veinous congesion parameters such as weight variation, cumulative fluid balance, peripheral edema, central venous pressure, urine output and acute kidney failure KDIGO stage.

You may qualify if:

• intubated for more than 24 hours

You may not qualify if:

• Chronic end-stage renal disease on admission
• Atrial Fibrillation
• Cirrhosis
• Portal thrombosis
• Refusal to participate
• non-opposition could not be obtained from themselves or their trusted support person in the event of incapacity
• Under legal protection.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

Hyperemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Gwenael PRAT, phD

CONTACT

0298347181; gwenael.prat@chu-brest.fr

Hamza CHRAIBI, phD

CONTACT

0298347181; hamza.chraibi@chu-brest.fr

Study Design

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

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 6, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)