Determinants of Portal Vein Pulsatility Index

August 31, 2024 updated by: Balan Ion Cosmin, Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fluid Intolerance
Time Frame: Within the first six hours of admission to the intensive care unit (simultaneously with other measures).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Volemia
Time Frame: Within the first six hours of admission to the intensive care unit (simultaneously with other measures).
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
Time Frame: Within the first six hours of admission to the intensive care unit (simultaneously with other measures).
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Serban-Ion Bubenek-Turconi, Professor, "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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