An observational study in Congestion, Venous, sponsored by University Hospital, Brest. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by University Hospital, Brest · Observational
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.
98 studies on the registry are indexed under Hyperemia; 44 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 46 observational studies indexed under Hyperemia.
Browse Hyperemia studies →University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
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.
Time frame: 24 hours after intubation and after every 48 hours until extubation up to 12 weeks
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: 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
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Oct 2028, 43 months after the start.
Of 28 observational studies under Hyperemia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 27. This study's planned 43 months is above that.
How these figures are worked out, and which studies are left out of them.
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