Determinants of Portal Vein Pulsatility Index

Determinants of Portal Vein Pulsatility Index: An Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Fluid Overload; Congestion

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania, 022328
    • "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated postoperative adult patients after cardiac surgery within 6 hours after intensive care unit admission.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cardiac Surgery Patients; Mechanically ventilated postoperative adult patients after cardiac surgery within 6 hours after intensive care unit admission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within the first six hours of admission to the intensive care unit (simultaneously with other measures).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volemia	Volemia will be assessed using the mean systemic filling pressure analogue (MSFPa), which estimates the overall volume status and preload of the circulatory system. This measurement provides an indirect evaluation of volemia, reflecting the balance between blood volume and vascular capacity. Higher or lower values can indicate fluid overload or deficit, respectively.	Within the first six hours of admission to the intensive care unit (simultaneously with other measures).
Right Ventricular Dysfunction	Right ventricular dysfunction will be assessed using three ancillary measures: Tricuspid Annular Plane Systolic Excursion (TAPSE), Right Ventricular Fractional Area Change (RVFAC), and the Right Ventricular End-Diastolic Area to Left Ventricular End-Diastolic Area ratio (RVEDA/LVEDA). TAPSE measures longitudinal shortening of the right ventricle, RVFAC assesses overall systolic function by evaluating the change in the right ventricular area during the cardiac cycle, and RVEDA/LVEDA compares the size of the right ventricle to the left, indicating potential dilation or pressure overload.	Within the first six hours of admission to the intensive care unit (simultaneously with other measures).

Collaborators and Investigators

• Sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
• Investigators: Study Director: Serban-Ion Bubenek-Turconi, Professor, "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 31, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: volemia; fluid therapy; congestion; right ventricular failure; portal vein pulsatility
• Other Study ID Numbers: 9593/04.04.2024

Drug and device information, study documents

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