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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Informed | Experimental | The treating team receives the patient's VExUS results and management recommendations. |
|
| Non-informed | Placebo Comparator | The treating team remains blinded to all VExUS findings and receives no feedback or recommendations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timothy I Kennell, MD, PhD | Contact | 2059965864 | tkennell@uabmc.edu | |
| Steve Fox, MD | Contact | 2059965864 | swfox@uabmc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Medical Center | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38374167 | Background | 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. | |
| 37291662 |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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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
|
| No intervention | Other | Primary team will not be informed about the patient's VExUS score and will not be given recommendations for fluid management |
|
| 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. |
| 38659788 | 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. |
| 34146184 | 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. |
| 40029471 | 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. |
| 37542955 | 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. |
| 27179835 | 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. |
| 40286489 | 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. |
| 37813180 | 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. |
| 38517247 | 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. |
| 38548949 | 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. |
| 37812993 | 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. |
| 37154067 | 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. |
| 37742087 | 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. |
| 37237315 | 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. |
| 37310104 | 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. |
| 36199091 | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |