Venous Congestion Clinical Trial
Official title:
Assessing Fluid Intolerance Using Portal Vein Pulsatility Index Post-Passive Leg Raising Test in Fluid Responders: A Prospective Cohort Study
NCT number | NCT06440772 |
Other study ID # | 9593/04.04.2024 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2023 |
Est. completion date | July 1, 2024 |
This study uses the portal vein pulsatility index (PVPI) to assess fluid intolerance amongst fluid responders.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | July 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Informed consent. - Mechanically ventilated patients within 6 hours after ICU admission following surgery who are considered for fluid administration to optimize haemodynamics. - Sinus rhythm. Exclusion Criteria: - A condition known to interfere with portal vein flow assessment or interpretation (liver cirrhosis or chronic hepatic disease, suprahepatic or portal vein thrombosis). - Any mechanical circulatory support. - Cardiac transplant. - Poor transthoracic echocardiographic window. |
Country | Name | City | State |
---|---|---|---|
Romania | "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases | Bucharest |
Lead Sponsor | Collaborator |
---|---|
Institutul de Urgenta pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fluid Intolerance | A portal vein pulsatility index greater than 50%, calculated as (Vmax - Vmin) / Vmax, with no upper limit and 0% as the minimum limit. Higher values indicate worse outcomes. Ultrasonographic portal spectral waveform was used to measure Vmax and Vmin. | 10 minutes after 7 ml/kg Ringer's Lactate |
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