NCT07826481

Brief Summary

Venous congestion is common in critically ill postoperative patients and may be associated with adverse outcomes. Doppler ultrasound assessment of venous flow patterns, including portal venous pulsatility, is increasingly used to evaluate systemic venous congestion. This prospective observational study aims to determine the correlation between portal venous pulsatility and splenic venous pulsatility measured by Doppler ultrasound in adult patients admitted to a postoperative intensive care unit. The study will evaluate whether splenic venous pulsatility may provide additional information for the assessment of venous congestion. Ultrasound examinations will be performed in addition to standard clinical care, without any therapeutic intervention or modification of patient management.

Trial Health

65
Monitor

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
13mo left

Started Nov 2026

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 14, 2026

Last Update Submit

September 14, 2026

Conditions

Keywords

Venous Excess Ultrasound (VExUS)Portal Venous Pulsatility IndexDoppler UltrasoundFluid ManagementIntensive Care UnitPostoperative Patients

Outcome Measures

Primary Outcomes (1)

  • Correlation between portal venous pulsatility index (portal PI) and splenic venous pulsatility index (splenic PI) measured by Doppler ultrasound.

    The primary outcome is the degree of correlation between portal and splenic venous pulsatility indices assessed during the same ultrasound examination in postoperative critically ill patients.

    Baseline assessment during the first 72 hours after admission to the postoperative intensive care unit.

Eligibility Criteria

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

Adult patients admitted to the postoperative intensive care unit after major surgery. Participants will undergo Doppler ultrasound assessment of portal and splenic venous pulsatility during the early postoperative period to evaluate the relationship between venous pulsatility patterns and systemic venous congestion.

You may not qualify if:

  • Known chronic liver disease or previous portal hypertension. Previous pathological splenomegaly or prior splenectomy. Recent hepatic or splenic surgery during the same hospitalization. Known portal or splenic vein thrombosis. Absence of an adequate ultrasound window after two attempts by trained operators.
  • Death or discharge from the intensive care unit before completion of the first protocolized ultrasound assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperemia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

LUCIA VALENCIA, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Intensive Care Unit Attending Physician

Study Record Dates

First Submitted

September 14, 2026

First Posted

September 17, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

September 17, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share