Doppler Evaluation for Congestive Acute Kidney Injury in Critical Illness (DECONGEST-AKI)

April 30, 2026 updated by: Steven W Fox, University of Alabama at Birmingham

The Impact of VeXUS-guided Fluid Management in ICU Populations on Renal Function

This study will evaluate the use of the Venous Excess Ultrasound (VExUS) score to guide fluid management in critically ill ICU patients through a prospective, multi-aim design combining observational and randomized components. The study will be conducted in the medical intensive care unit (MICU), multidisciplinary critical care unit (MCCU), and cardiac care unit (CCU) at UAB.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the use of the Venous Excess Ultrasound (VExUS) score to guide fluid management in critically ill ICU patients through a prospective, multi-aim design combining observational and randomized components. The study will be conducted in the medical intensive care unit (MICU), multidisciplinary critical care unit (MCCU), and cardiac care unit (CCU) at UAB.

Informed Arm: The treating team receives the patient's VExUS results and management recommendations.

Not-Informed Arm: The treating team remains blinded to all VExUS findings and receives no feedback or recommendations.

Each enrolled patient will undergo two VExUS ultrasound assessments:

Timepoint 1 (enrollment): Two scans are performed by separate operators to assess waveform reliability and inter-user reproducibility.

Timepoint 2 (48-72 hours after enrollment): A single scan is performed along with concurrent collection of serum creatinine, intake/output (I&O) balance, and renal replacement therapy (RRT) status.

Each VExUS exam includes Doppler evaluation of the inferior vena cava, hepatic vein, portal vein, renal cortical artery, and renal cortical vein. Scans are saved to secure UAB SharePoint storage labeled with an auto-incrementing study ID.

Blinding Procedures

To maintain study integrity and minimize bias, multiple layers of blinding will be employed:

Scanner Blinding: Sonographers performing the VExUS scans are blinded to the patient's randomization status and to all prior scan results. They collect and upload de-identified images labeled only by study ID.

Interpreter Blinding: The attending physician interpreting the scans (the "overreader") is blinded to randomization status during the image interpretation phase. The overreader reviews both scans for quality and assigns a VExUS score (0-3) before randomization status is revealed.

Recruiter/Coordinator Role: The research coordinator (unblinded) maintains the randomization list and is responsible for communicating the overread results to the treating team only for patients in the informed arm.

Primary Team Blinding: For patients in the not-informed arm, the primary clinical team will not receive any VExUS scores or recommendations, and no study-related documentation will be visible in the electronic health record (EHR).

Statistical Blinding: Data analysts will remain blinded to treatment arm allocation until after all primary outcomes are recorded.

Communication and Clinical Guidance

For patients in the informed arm, the overreader will generate standardized recommendations based on the VExUS score:

VExUS = 0: Recommend a net positive fluid balance.

VExUS = 1: Recommend a net neutral fluid balance.

VExUS >= 2: Recommend a net negative fluid balance.

These recommendations will be communicated to the treating team via a structured process: documentation in the EHR under the POCUS note and verbal handoff to the resident, fellow, and attending on the primary team.

Data Management and Analysis

Two linked data lists will be maintained:

Master List (PHI-protected): Contains patient identifiers and MRNs, stored on a secure UAB server.

Patient Data List (de-identified): Contains study ID, randomization arm, scan quality, interpreter scores, creatinine values, I&O data, RRT status, ICU-free days, hospital-free days, and mortality.

All ultrasound procedures are noninvasive and adhere to ACEP emergency ultrasound standards. Protected health information will remain secured on institutional servers, and only de-identified data will be used for analysis.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham Medical Center
        • Contact:
        • Principal Investigator:
          • Steve Fox, MD
        • Sub-Investigator:
          • Timothy I Kennell, MD, PhD

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

Description

Inclusion Criteria:

  • Adults (≥18 years old)
  • Admitted to the MICU, MCCU, or CCU within 24 hours of admission
  • Acute kidney injury (AKI) (based on Kidney Disease: Improving Global Outcomes (KDIGO) criteria)
  • Adequate acoustic windows for a complete VExUS scan

Exclusion Criteria:

  • < 18 years old
  • pregnant women
  • End-stage renal disease (ESRD) or prior renal transplant
  • Acute tubular necrosis (ATN) defined by urinalysis (≥2+ protein, ≥2+ blood, ≥1 muddy brown cast, ≥1 RBC cast, or ≥1 dysmorphic RBC)'
  • Prior Whipple procedures
  • currently incarcerated

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Informed
The treating team receives the patient's VExUS results and management recommendations.
Other: Fluid Management

For patients in the informed arm, the overreader will generate standardized recommendations based on the VExUS score:

VExUS = 0: Recommend a net positive fluid balance.

VExUS = 1: Recommend a net neutral fluid balance.

VExUS >= 2: Recommend a net negative fluid balance.

These recommendations will be communicated to the treating team via a structured process: documentation in the EHR under the POCUS note and verbal handoff to the resident, fellow, and attending on the primary team.
Placebo Comparator: Non-informed
The treating team remains blinded to all VExUS findings and receives no feedback or recommendations.
Other: No intervention
Primary team will not be informed about the patient's VExUS score and will not be given recommendations for fluid management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital Mortality
Time Frame: up to 30 days
In-hospital mortality: Death from any cause before hospital discharge, within the 30-day window.
up to 30 days
Renal Replacement Therapy
Time Frame: up to 30 days
New receipt of Renal Replacement Therapy (RRT): Receiving dialysis or another form of RRT for the first time.
up to 30 days
Persistent Renal Dysfunction
Time Frame: up to 30 days
Persistent renal dysfunction: The final serum creatinine value before hospital discharge (within 30 days) is 200% (twice) or more of the patient's baseline creatinine value.
up to 30 days

Collaborators and Investigators

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

Sponsor

University of Alabama at Birmingham

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 (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300015346
  • UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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