NCT07183397

Brief Summary

The objective of this study is to assess how fluid resuscitation, in the context of fluid responsiveness, affects the incidence and progression of systemic venous congestion in critically ill cardiac patients. Additionally, the study aims to evaluate the impact on clinical outcomes, with a particular focus on acute kidney dysfunction. This assessment will utilize the VExUS score in conjunction with comprehensive bedside echocardiographic evaluations.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Sep 2025

Typical duration for all trials

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

Study Progress29%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

September 14, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 14, 2025

Last Update Submit

September 14, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Venous congestion

    Venous congestion as assessed by the VExUS score at ICU admission, and on each of the first seven postoperative days.

    7 days

  • Acute kidney injury

    Acute kidney injury (AKI), defined through the KDIGO criteria, within seven and twenty-eight days of ICU admission.

    Twenty-eight days

Interventions

The VExUS system provides a semi-quantitative assessment of systemic venous congestion by integrating ultrasound evaluations of the inferior vena cava diameter, hepatic vein flow, portal pulsatility, and renal venous flow, offering a practical and comprehensive bedside tool

Eligibility Criteria

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

Cardiac critically ill patients (mainly post cardiac surgery)

You may qualify if:

  • Age above 18 years
  • Admission to cardiac intensive care unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Samples

MeSH Terms

Conditions

Hyperemia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Pedro D Wendel Garcia, Dr. med.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.med.

Study Record Dates

First Submitted

September 14, 2025

First Posted

September 19, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

September 19, 2025

Record last verified: 2025-09