AzTrials
AzTrials

Acute Kidney InjuryDECONGEST-AKINCT07291778

Doppler Evaluation for Congestive Acute Kidney Injury in Critical Illness

A study testing Fluid Management in people with Acute Kidney Injury and VExUS, run by University of Alabama at Birmingham at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Kidney Injury, VExUS
What is being tested?
Fluid Management
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteUnited States
Study dates
1 Dec 2026to 1 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • < 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Timothy I Kennell, MD, PhD contact

2059965864

tkennell@uabmc.edu

Steve Fox, MD contact

2059965864

swfox@uabmc.edu

United States1 site
  • University of Alabama at Birmingham Medical Center

    Birmingham, Alabama, 35294

    Timothy I Kennell, MD, PhD, 2059965864, tkennell@uabmc.edu

    Steve Fox, MD

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Fluid Management, No intervention
Keywords
VExUS, Fluid Management, Acute Kidney Injury, ICU
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluid ManagementOther

    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.

  • No interventionOther

    Primary team will not be informed about the patient's VExUS score and will not be given recommendations for fluid management

Study groups in NCT07291778
Study groupRoleWhat they receive
InformedExperimentalThe treating team receives the patient's VExUS results and management recommendations.
Receives: Other: Fluid Management
Non-informedPlacebo comparatorThe treating team remains blinded to all VExUS findings and receives no feedback or recommendations.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-hospital Mortality

    In-hospital mortality: Death from any cause before hospital discharge, within the 30-day window.

    Measured: up to 30 days

  2. Renal Replacement Therapy

    New receipt of Renal Replacement Therapy (RRT): Receiving dialysis or another form of RRT for the first time.

    Measured: up to 30 days

  3. Persistent Renal Dysfunction

    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.

    Measured: up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07291778
Sponsor's protocol ID
IRB-300015346
Other IDs
UAB
Acronym
DECONGEST-AKI
Status last verified
Jul 2026
First submitted
5 Dec 2025
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Munoz F, Born P, Bruna M, Ulloa R, Gonzalez C, Philp V, Mondaca R, Blanco JP, Valenzuela ED, Retamal J, Miralles F, Wendel-Garcia PD, Ospina-Tascon GA, Castro R, Rola P, Bakker J, Hernandez G, Kattan E. Coexistence of a fluid responsive state and venous congestion signals in critically ill patients: a multicenter observational proof-of-concept study. Crit Care. 2024 Feb 19;28(1):52. doi: 10.1186/s13054-024-04834-1.

    PubMed 38374167
  • Andrei S, Bahr PA, Nguyen M, Bouhemad B, Guinot PG. Prevalence of systemic venous congestion assessed by Venous Excess Ultrasound Grading System (VExUS) and association with acute kidney injury in a general ICU cohort: a prospective multicentric study. Crit Care. 2023 Jun 8;27(1):224. doi: 10.1186/s13054-023-04524-4.

    PubMed 37291662
  • Leyba K, Longino A, Ormesher R, Krienke M, Van Ochten N, Zimmerman K, McCormack L, Martin K, Thai T, Furgeson S, Teitelbaum I, Burke J, Douglas I, Gill E. Venous excess ultrasonography (VExUS) captures dynamic changes in volume status surrounding hemodialysis: A multicenter prospective observational study. Res Sq [Preprint]. 2024 Apr 8:rs.3.rs-4185584. doi: 10.21203/rs.3.rs-4185584/v1.

    PubMed 38659788
  • Rola P, Miralles-Aguiar F, Argaiz E, Beaubien-Souligny W, Haycock K, Karimov T, Dinh VA, Spiegel R. Clinical applications of the venous excess ultrasound (VExUS) score: conceptual review and case series. Ultrasound J. 2021 Jun 19;13(1):32. doi: 10.1186/s13089-021-00232-8.

    PubMed 34146184
  • Melo RH, Gioli-Pereira L, Melo E, Rola P. Venous excess ultrasound score association with acute kidney injury in critically ill patients: a systematic review and meta-analysis of observational studies. Ultrasound J. 2025 Mar 3;17(1):16. doi: 10.1186/s13089-025-00413-9.

    PubMed 40029471
  • Gomez-Rodriguez C, Tadeo-Espinoza H, Solis-Huerta F, Leal-Villarreal MAJ, Guerrero-Cabrera P, Cruz N, Gaytan-Arocha JE, Soto-Mota A, Vasquez Z, Gamba G, Verbrugge FH, Argaiz ER. Hemodynamic Evaluation of Right-Sided Congestion With Doppler Ultrasonography in Pulmonary Hypertension. Am J Cardiol. 2023 Sep 15;203:459-462. doi: 10.1016/j.amjcard.2023.07.007. Epub 2023 Aug 4. No abstract available.

    PubMed 37542955
  • Iida N, Seo Y, Sai S, Machino-Ohtsuka T, Yamamoto M, Ishizu T, Kawakami Y, Aonuma K. Clinical Implications of Intrarenal Hemodynamic Evaluation by Doppler Ultrasonography in Heart Failure. JACC Heart Fail. 2016 Aug;4(8):674-82. doi: 10.1016/j.jchf.2016.03.016. Epub 2016 May 11.

    PubMed 27179835
  • Klompmaker P, Mousa A, Allard DJ, Hagen BSH, Banki T, Vermeulen W, de Waal M, van Wolfswinkel S, De Grooth HJS, Veelo DP, Vlaar APJ, Tuinman PR. The association between venous excess ultrasound grading system (VExUS) and major adverse kidney events after 30 days in critically ill patients: A prospective cohort study. J Crit Care. 2025 Aug;88:155097. doi: 10.1016/j.jcrc.2025.155097. Epub 2025 Apr 25.

    PubMed 40286489
  • Longino A, Martin K, Leyba K, Siegel G, Thai TN, Riscinti M, Douglas IS, Gill E, Burke J. Prospective Evaluation of Venous Excess Ultrasound for Estimation of Venous Congestion. Chest. 2024 Mar;165(3):590-600. doi: 10.1016/j.chest.2023.09.029. Epub 2023 Oct 7.

    PubMed 37813180
  • Trigkidis KK, Siempos II, Kotanidou A, Zakynthinos S, Routsi C, Kokkoris S. EARLY TRAJECTORY OF VENOUS EXCESS ULTRASOUND SCORE IS ASSOCIATED WITH CLINICAL OUTCOMES OF GENERAL ICU PATIENTS. Shock. 2024 Mar 1;61(3):400-405. doi: 10.1097/SHK.0000000000002321. Epub 2024 Feb 27.

    PubMed 38517247
  • Prager R, Arntfield R, Wong MYS, Ball I, Lewis K, Rochwerg B, Basmaji J. Venous congestion in septic shock quantified with point-of-care ultrasound: a pilot prospective multicentre cohort study. Can J Anaesth. 2024 May;71(5):640-649. doi: 10.1007/s12630-024-02717-1. Epub 2024 Mar 28.

    PubMed 38548949
  • Li ZT, Huang DB, Zhao JF, Li H, Fu SQ, Wang W. Comparison of various surrogate markers for venous congestion in predicting acute kidney injury following cardiac surgery: A cohort study. J Crit Care. 2024 Feb;79:154441. doi: 10.1016/j.jcrc.2023.154441. Epub 2023 Oct 7.

    PubMed 37812993
  • Viana-Rojas JA, Argaiz E, Robles-Ledesma M, Arias-Mendoza A, Najera-Rojas NA, Alonso-Bringas AP, De Los Rios-Arce LF, Armenta-Rodriguez J, Gopar-Nieto R, Briseno-De la Cruz JL, Gonzalez-Pacheco H, Sierra-Lara Martinez D, Gonzalez-Salido J, Lopez-Gil S, Araiza-Garaygordobil D. Venous excess ultrasound score and acute kidney injury in patients with acute coronary syndrome. Eur Heart J Acute Cardiovasc Care. 2023 Jul 7;12(7):413-419. doi: 10.1093/ehjacc/zuad048.

    PubMed 37154067
  • 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.

    PubMed 37742087
  • Longino A, Martin K, Leyba K, Siegel G, Gill E, Douglas IS, Burke J. Correlation between the VExUS score and right atrial pressure: a pilot prospective observational study. Crit Care. 2023 May 26;27(1):205. doi: 10.1186/s13054-023-04471-0.

    PubMed 37237315

Questions about this trial

What is this clinical trial studying?

A study testing Fluid Management in people with Acute Kidney Injury and VExUS, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Timothy I Kennell, MD, PhD (2059965864, tkennell@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital Mortality (time frame: up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07291778, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in