Doppler Evaluation for Congestive Acute Kidney Injury in Critical Illness

NCT07291778 | Not Yet Recruiting

• 2 other identifiers: IRB-300015346UAB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. The study will be conducted in the medical intensive care unit (MICU), multidisciplinary critical care unit (MCCU), and cardiac care unit (CCU) at UAB.

Conditions

Acute Kidney Injury; VExUS

Keywords

VExUS; Fluid Management; Acute Kidney Injury; ICU

Outcome Measures

Primary Outcomes (3)

• In-hospital Mortality

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

  up to 30 days

• Renal Replacement Therapy

  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

  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

Study Arms (2)

Informed

EXPERIMENTAL

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

Other: Fluid Management

Non-informed

PLACEBO COMPARATOR

The treating team remains blinded to all VExUS findings and receives no feedback or recommendations.

Other: No intervention

Interventions

Fluid Management OTHER

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.

Informed

No intervention OTHER

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

Non-informed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35294, United States

Location

Related Publications (17)

• 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.

  PMID: 38374167 BACKGROUND

• 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.

  PMID: 37291662 BACKGROUND

• 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.

  PMID: 38659788 BACKGROUND

• 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.

  PMID: 34146184 BACKGROUND

• 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.

  PMID: 40029471 BACKGROUND

• 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.

  PMID: 37542955 BACKGROUND

• 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.

  PMID: 27179835 BACKGROUND

• 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.

  PMID: 40286489 BACKGROUND

• 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.

  PMID: 37813180 BACKGROUND

• 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.

  PMID: 38517247 BACKGROUND

• 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.

  PMID: 38548949 BACKGROUND

• 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.

  PMID: 37812993 BACKGROUND

• 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.

  PMID: 37154067 BACKGROUND

• 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.

  PMID: 37742087 BACKGROUND

• 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.

  PMID: 37237315 BACKGROUND

• Rihl MF, Pellegrini JAS, Boniatti MM. VExUS Score in the Management of Patients With Acute Kidney Injury in the Intensive Care Unit: AKIVEX Study. J Ultrasound Med. 2023 Nov;42(11):2547-2556. doi: 10.1002/jum.16288. Epub 2023 Jun 13.

  PMID: 37310104 BACKGROUND

• Guinot PG, Bahr PA, Andrei S, Popescu BA, Caruso V, Mertes PM, Berthoud V, Nguyen M, Bouhemad B. Doppler study of portal vein and renal venous velocity predict the appropriate fluid response to diuretic in ICU: a prospective observational echocardiographic evaluation. Crit Care. 2022 Oct 5;26(1):305. doi: 10.1186/s13054-022-04180-0.

  PMID: 36199091 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Timothy I Kennell, MD, PhD

CONTACT

2059965864; tkennell@uabmc.edu

Steve Fox, MD

CONTACT

2059965864; swfox@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (1)