NCT06582368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

August 30, 2024

Last Update Submit

September 5, 2024

Conditions

Fluid OverloadCongestion

Keywords

congestionportal vein pulsatilityfluid therapyright ventricular failurevolemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Volemia

    Within the first six hours of admission to the intensive care unit (simultaneously with other measures).

  • Right Ventricular Dysfunction

    Within the first six hours of admission to the intensive care unit (simultaneously with other measures).

Study Arms (1)

Cardiac Surgery Patients

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Informed consent.
  • Mechanically ventilated patients within 6 hours after ICU admission following surgery who are considered for fluid administration to optimize haemodynamics.
  • Sinus rhythm.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

Bucharest, 022328, Romania

Location

Related Publications (2)

  • 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.

    PMID: 19002596BACKGROUND

  • 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.

    PMID: 37742087BACKGROUND

MeSH Terms

Conditions

EdemaHeart Failure

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Serban-Ion Bubenek-Turconi, Professor

    "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2024

First Posted

September 3, 2024

Study Start

May 1, 2023

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

RO(1)