Clinical trial NCT06582368: Determinants of Portal Vein Pulsatility Index
Official title: Determinants of Portal Vein Pulsatility Index: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Overload
Congestion
Keywords: congestion
portal vein pulsatility
fluid therapy
right ventricular failure
volemia
Lead sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mechanically ventilated postoperative adult patients after cardiac surgery within 6 hours after intensive care unit admission.

Brief summary: The pulsatile pattern of the portal vein is considered a marker of right ventricular dysfunction, but volemia may also contribute to this phenomenon. The separate influence of each factor remains debated, as the interplay between right ventricular dysfunction and volume status is complex. Additionally, right ventricular dysfunction can originate from either diastolic or systolic dysfunction, further complicating the understanding of their distinct impacts on portal vein pulsatility.

Detailed description: The pulsatile pattern of the portal vein has been recognized as a potential marker of right ventricular dysfunction, reflecting altered hemodynamics in the venous system. However, the role of volemia, or the volume status of a patient, might also significantly influence this pulsatility, complicating the interpretation of portal vein flow patterns. The distinct and combined effects of right ventricular dysfunction and volemia on portal vein pulsatility are still subjects of ongoing debate. Right ventricular dysfunction itself can arise from multiple mechanisms, including primary diastolic dysfunction, where the ventricle has impaired filling and relaxation, or systolic dysfunction, characterized by reduced contractility and ejection capacity. Understanding whether diastolic or systolic dysfunction plays a predominant role in altering portal vein pulsatility is crucial, as these nuances have important implications for accurately identifying the determinants of portal vein pulsatility index and tailoring appropriate clinical interventions.

Eligibility criteria: 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.

Primary outcomes:
measure: Fluid Intolerance
timeFrame: Within the first six hours of admission to the intensive care unit (simultaneously with other measures).
Secondary outcomes:
measure: Volemia
timeFrame: Within the first six hours of admission to the intensive care unit (simultaneously with other measures).
measure: Right Ventricular Dysfunction
timeFrame: Within the first six hours of admission to the intensive care unit (simultaneously with other measures).
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
Study officials:
affiliation: "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
name: Serban-Ion Bubenek-Turconi, Professor
role: STUDY_DIRECTOR
References:
citation: Parkin WG, Leaning MS. Therapeutic control of the circulation. J Clin Monit Comput. 2008 Dec;22(6):391-400. doi: 10.1007/s10877-008-9147-7. Epub 2008 Nov 12.
citation: Utrilla-Alvarez JD, Gopar-Nieto R, Garcia-Cruz E, Lazcano-Diaz E, Jimenez-Rodriguez GM, Rojas-Velasco G, Manzur-Sandoval D. Assessing the venous system: Correlation of mean systemic filling pressure with the venous excess ultrasound grading system in cardiac surgery. Echocardiography. 2023 Nov;40(11):1216-1226. doi: 10.1111/echo.15697. Epub 2023 Sep 23.