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

Hepatic Doppler to Assess Venous Congestion During Invasive Mechanical Ventilation

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.

Study Overview

• Status: Recruiting
• Conditions: Congestion, Venous

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Gwenael PRAT, phD; Phone Number: +33 0298347181; Email: gwenael.prat@chu-brest.fr
• Study Contact Backup: Name: Hamza CHRAIBI, phD; Phone Number: +33 0298347181; Email: hamza.chraibi@chu-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • CHU Brest
    • Contact: Hamza CHRAIBI; Phone Number: +33 298347181; Email: hamza.chraibi@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• intubated for more than 24 hours

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2025
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hyperemia
• Other Study ID Numbers: 29BRC25.0048 - DOHECOV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No