Usefulness of the VExUS Protocol for Dry-Weight Adjustment in Hemodialysis Patients: The Multicenter VExHD Study

NCT07659197 | Completed

• 2 other identifiers: 48681309Beca de investigación
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this prospective observational study is to determine the utility of ultrasonographic assessment using the VExUS protocol for dry weight adjustment in clinically euvolemic patients undergoing hemodialysis. The primary hypothesis is that the assessment of venous congestion by ultrasound may help identify patients who can tolerate increased ultrafiltration, thereby improving blood pressure control. The comparison group will consist of patients who do not meet the criteria for venous congestion according to the VExUS protocol. In patients meeting the criteria for venous congestion, the ultrafiltration volume during hemodialysis will be increased.

Conditions

Hypertension (HTN); Hemodialysis

Keywords

vexus; Hypertension; hemodialysis; dry weight

Outcome Measures

Primary Outcomes (1)

• Change in Dry weight

  To evaluate the usefulness of the VExUS protocol in dry-weight adjustment in hemodialysis patients.

  4 weeks

Secondary Outcomes (1)

• Change in systolic blood pressure

  4 weeks

Study Arms (2)

congestive

EXPERIMENTAL

Patients who have increased ultrafiltration

Behavioral: Increased ultrafiltration

Non-congested

ACTIVE COMPARATOR

Patients in whom ultrafiltration was not increased

Behavioral: No increase in ultrafiltration

Interventions

Increased ultrafiltration BEHAVIORAL

In patients meeting the predefined ultrasonographic criteria for venous congestion, the prescribed dry weight will be reduced by 0.3 kg per week, resulting in a corresponding increase in the ultrafiltration volume during hemodialysis sessions.

congestive

No increase in ultrafiltration BEHAVIORAL

In patients who do not meet the predefined ultrasonographic criteria for venous congestion, the ultrafiltration prescription will remain unchanged.

Non-congested

Eligibility Criteria

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

You may qualify if:

• Patients over 18 years of age who are currently on hemodialysis (more than 90 days since the start of the program)
• A schedule of three days per week at the centers included in the study
• Signed informed consent

You may not qualify if:

• Clinical signs and symptoms of volume overload
• Patients with liver disease (liver cirrhosis, steatosis, portal vein thrombosis)
• Severe tricuspid regurgitation
• Inability to hold one's breath
• Obesity

Sponsors & Collaborators

• Fundación Senefro: lead
• SOMANE (MADRID SOCIETY OF NEPHROLOGY): collaborator

Study Sites (1)

Hospital Universitario Infanta Leonor

Madrid, Madrid, 28055, Spain

Location

Related Publications (9)

• Zoccali C, Torino C, Mallamaci F, Sarafidis P, Papagianni A, Ekart R, Hojs R, Klinger M, Letachowicz K, Fliser D, Seiler-Mussler S, Lizzi F, Wiecek A, Miskiewicz A, Siamopoulos K, Balafa O, Slotki I, Shavit L, Stavroulopoulos A, Covic A, Siriopol D, Massy ZA, Seidowsky A, Battaglia Y, Martinez-Castelao A, Polo-Torcal C, Coudert-Krier MJ, Rossignol P, Fiaccadori E, Regolisti G, Hannedouche T, Bachelet T, Jager KJ, Dekker FW, Tripepi R, Tripepi G, Gargani L, Sicari R, Picano E, London GM. A randomized multicenter trial on a lung ultrasound-guided treatment strategy in patients on chronic hemodialysis with high cardiovascular risk. Kidney Int. 2021 Dec;100(6):1325-1333. doi: 10.1016/j.kint.2021.07.024. Epub 2021 Aug 19.

  PMID: 34418415 BACKGROUND

• Loutradis C, Papadopoulos CE, Sachpekidis V, Ekart R, Krunic B, Papadopoulou D, Papagianni A, Mallamaci F, Zoccali C, Sarafidis PA. Lung ultrasound-guided dry-weight reduction and echocardiographic changes in clinically euvolemic hypertensive hemodialysis patients: 12-month results of a randomized controlled trial. Hellenic J Cardiol. 2022 Mar-Apr;64:1-6. doi: 10.1016/j.hjc.2021.11.002. Epub 2021 Nov 29.

  PMID: 34856379 BACKGROUND

• Zoccali C, Torino C, Tripepi R, Tripepi G, D'Arrigo G, Postorino M, Gargani L, Sicari R, Picano E, Mallamaci F; Lung US in CKD Working Group. Pulmonary congestion predicts cardiac events and mortality in ESRD. J Am Soc Nephrol. 2013 Mar;24(4):639-46. doi: 10.1681/ASN.2012100990. Epub 2013 Feb 28.

  PMID: 23449536 BACKGROUND

• Flythe JE, Xue H, Lynch KE, Curhan GC, Brunelli SM. Association of mortality risk with various definitions of intradialytic hypotension. J Am Soc Nephrol. 2015 Mar;26(3):724-34. doi: 10.1681/ASN.2014020222. Epub 2014 Sep 30.

  PMID: 25270068 BACKGROUND

• Loutradis C, Sarafidis PA, Ekart R, Tsouchnikas I, Papadopoulos C, Kamperidis V, Alexandrou ME, Ferro CJ, Papagianni A, London G, Mallamaci F, Zoccali C. Ambulatory blood pressure changes with lung ultrasound-guided dry-weight reduction in hypertensive hemodialysis patients: 12-month results of a randomized controlled trial. J Hypertens. 2021 Jul 1;39(7):1444-1452. doi: 10.1097/HJH.0000000000002818.

  PMID: 34074973 BACKGROUND

• Pandhi P, Ter Maaten JM, Anker SD, Ng LL, Metra M, Samani NJ, Lang CC, Dickstein K, de Boer RA, van Veldhuisen DJ, Voors AA, Sama IE. Pathophysiologic Processes and Novel Biomarkers Associated With Congestion in Heart Failure. JACC Heart Fail. 2022 Sep;10(9):623-632. doi: 10.1016/j.jchf.2022.05.013.

  PMID: 36049813 BACKGROUND

• Romero-Gonzalez G, Manrique J, Slon-Roblero MF, Husain-Syed F, De la Espriella R, Ferrari F, Bover J, Ortiz A, Ronco C. PoCUS in nephrology: a new tool to improve our diagnostic skills. Clin Kidney J. 2022 Sep 12;16(2):218-229. doi: 10.1093/ckj/sfac203. eCollection 2023 Feb.

  PMID: 36755847 BACKGROUND

• Kaptein MJ, Kaptein EM. Inferior Vena Cava Collapsibility Index: Clinical Validation and Application for Assessment of Relative Intravascular Volume. Adv Chronic Kidney Dis. 2021 May;28(3):218-226. doi: 10.1053/j.ackd.2021.02.003.

  PMID: 34906306 BACKGROUND

• Ma L, Zhao S. Risk factors for mortality in patients undergoing hemodialysis: A systematic review and meta-analysis. Int J Cardiol. 2017 Jul 1;238:151-158. doi: 10.1016/j.ijcard.2017.02.095. Epub 2017 Feb 22.

  PMID: 28341375 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Ultrafiltration

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Extracorporeal Circulation; Surgical Procedures, Operative; Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Physical Phenomena; Chemical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 22, 2026
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)