Intrarenal Venous Flow Change During Fluid Removal in Critically Ill Patients: A Prospective Exploratory Study

May 22, 2025 updated by: Mahidol University
This clinical trial aims to study intrarenal venous flow patterns change, VExUS score change, and LUS score change during fluid removal treatment in critically ill patients

Study Overview

Status

Completed

Conditions

Detailed Description

Background: In patients with heart failure, intrarenal venous flow patterns could change depending on the level of congestion and was strongly correlated with death from cardiovascular disease and unplanned hospitalization. However, the findings may differ in patients with sepsis in the intensive care unit. In this case, Intrarenal venous flow patterns were not associated with Central Venous Pressure but were associated with Acute Kidney Injury and death. This suggests that intrarenal venous flow patterns may serve as an indicator of renal congestion and could be a feasible bedside tool to predict various clinical implications. In addition, Point-of-care ultrasound (POCUS) techniques such as Venous Excess Ultrasound (VExUS) and Lung Ultrasound (LUS) provide non-invasive assessments of fluid status and venous congestion. This study evaluates changes in VExUS and LUS scores during fluid removal to predict clinical outcomes in critically ill patients.

Objective: We aimed to study intrarenal venous flow patterns change, VExUS score change, and LUS score change during fluid removal treatment in critically ill patients.

Methods:

  • After enrollment, patients will undergo baseline Doppler ultrasonography to evaluate intrarenal venous flow patterns and LUS before the initiation of fluid removal through diuretic therapy or renal replacement therapy.
  • After patients received fluid removal therapy, they will receive continuous ultrasonography monitoring within 24, 48, and 72 hours, along with data collection.

Researchers will collect data about

  • intrarenal venous flow patterns change, Venous Excess Ultrasound (VExUS) score change, and LUS score change during fluid removal treatment
  • establish a correlation between alterations in intrarenal flow patterns, VExUS score, and LUS score as well as other clinical data (Central venous pressure, Cumulative fluid balance) and clinical implications (Renal replacement therapy free day, Ventilator free day, length of Intensive care unit stay).

Study Type

Observational

Enrollment (Actual)

52

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

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Siriraj Hospital, Mahidol University

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients aged 18 years old or older who will be admitted to the medical intensive care unit and require fluid removal therapy

Description

Inclusion Criteria:

  1. Adult patients aged 18 years old or older who will be admitted to the medical intensive care unit
  2. Expected to be hospitalized in the intensive care unit for more than 120 hours.
  3. The patient has stable vital signs without the need for vasoactive medications or rapid fluid resuscitation (at least 500 milliliters of colloid or 1000 milliliters of crystalloid via rapid intravenous infusion) for a minimum consecutive period of 12 hours. This includes cases where the patient receives norepinephrine at a rate not exceeding 0.1 micrograms per kilogram per minute and dobutamine at a rate not exceeding 10 micrograms per kilogram per minute, or when the patient can maintain a continuous reduction in vasoactive medications for a minimum consecutive period of 12 hours.
  4. The patient does not exhibit signs suggestive of inadequate organ perfusion, such as mottling skin, a capillary refill time of more than 2 seconds when nailbeds are pressed and released, or cold extremities.
  5. The patients require fluid removal through decisions made by attending staff or clinical guidelines, which may involve the administration of diuretics or Renal Replacement Therapy.

Exclusion Criteria:

  1. Underlying chronic kidney disease (eGFR< 30) before enrollment
  2. Chronic renal replacement therapy (RRT) before enrollment such as on intermittent hemodialysis, peritoneal dialysis
  3. Decompensated cirrhosis with portal hypertension
  4. Inferior vena cava, portal vein, hepatic, renal vein thrombosis
  5. Ureteral obstruction
  6. Intraabdominal hypertension (Intraabdominal pressure > 12 mmHg)
  7. Previous allergic or anaphylactic to diuretic
  8. Pregnant women
  9. Transplanted kidney, transplanted liver
  10. Patients with do-not-resuscitate (DNR) orders or decisions to withhold life-sustaining treatments
  11. Patients or their legally authorized representatives (LAR), who decline participation in the study or are unable to provide informed consent before enrollment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intrarenal venous flow patterns change during fluid removal treatment in critically ill patients.
Time Frame: 72 hours after Fluid removal therapy
intrarenal venous flow patterns change measured by ultrasonography
72 hours after Fluid removal therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VExUS score change following fluid removal treatment in critically ill patients.
Time Frame: 72 hours after Fluid removal therapy
VExUS score change measured by ultrasonography
72 hours after Fluid removal therapy

Collaborators and Investigators

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

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Ranistha Ratanarat, MD, Division of Critical Care, Department of Medicine, Siriraj Hospital, Mahidol University
  • Study Director: Apatsara Saokaew, MD, Division of Critical Care, Department of Medicine, Siriraj Hospital, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 23, 2024

Primary Completion (Actual)

September 16, 2024

Study Completion (Actual)

October 13, 2024

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI929/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual participant data that underlie results in a publication of this study (after deidentification)

IPD Sharing Time Frame

All IPD will become available starting briefly following a publication of the study with no end date.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by institutional review board or ethical committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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