A Simplified Lung Ultrasound Guided Management Protocol Of Pulmonary Congestion in Hemodialysis

NCT06296160 | Recruiting

• 2 other identifiers: MRC-01-23-035LUSAM-HD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary congestion secondary to volume overload or interstitial tissue inflammation is common in chronic hemodialysis patients. This pulmonary congestion occurs mainly during the period between dialysis sessions and is an independent risk factor for cardiovascular event morbidity and mortality in this population. The evaluation of this pulmonary congestion and the estimation of the dry weight of hemodialysis patients according to conventional methods represent a real challenge for clinical nephrologists. Lung ultrasound is a new diagnostic approach validated in the assessment of pulmonary congestion. It would allow a better assessment of dry weight in chronic hemodialysis patients based on the results of preliminary studies, including our latest pilot study. However, there is little evidence comparing this novel approach to traditional approaches.

Conditions

End Stage Renal Disease

Keywords

Regular Hemodialysis; Fluid overload; lung cognition; Number of B-lines; Lung Ultrasound

Outcome Measures

Primary Outcomes (1)

• Assess the effectiveness of adding B-line score evaluation through lung ultrasound to the standard of care to improve pulmonary congestion (measured by B lines score) in hemodialysis patients

  Comparing the difference in B lines score (that reflects lung congestion) between both groups before (LUS day 1) and after (LUS day 60) the intervention (fluid removal adjustment by changing dry weight). B-line score is \>0.54/zone (BLS\>5) is cut-off score. 0-5 B-lines (BLS≤5) indicate \[No- Mild lung Congestion\], and if B-lines more than (BLS\>5) lines; indicate \[Moderate-severe lung congestion\].

  At baseline and at the end of 2 months follow-up

Secondary Outcomes (2)

• The impact of utilizing B lines score based additional fluid removal on interdialytic ambulatory blood pressure.

  At baseline and at the end of 2 months follow-up

• The impact of utilizing B lines score based additional fluid removal on intradialytic ambulatory blood pressure

  At baseline and at the end of 2 months follow-up

Study Arms (2)

Interventional Arm

EXPERIMENTAL

Based on the Ultrasound result, Dry Weight Modification: Duration: 2 months. Number of visits: 5 visits. A- Intervention Phase (Dry weight modification)= \[Day-1 and Day-15\] B- Observational Phase (No Dry weight modification on Day 30, Day 45, and Day 60).

Other: Intervention Group

Control Arm

NO INTERVENTION

* Includes patients who will receive usual ambulatory and at-discharge care. * No dry-weight modification (The study investigators will not modify the dry weight). * All subjects in the Control group will be under follow-up close observation for two months \[5 visits\]. * The participant will follow the standard of care practice (Dry Weight evaluation according to clinical judgment by the assigned physician and biological data. Study procedures: 1. Obtain a lung ultrasound after the midweek dialysis session. 2. The 8-zone lung ultrasound method calculates the number of B-line scores. 3. Check the Blood Pressure 3 times/day on non-Dialysis days. 4. Check the ambulatory blood pressure for 48 hours (Baseline on Day 1 and Follow-up on Day 60).

Interventions

Intervention Group OTHER

A- (Intervention Phase= (Day-1) + (Day-15) 1. Obtain a lung ultrasound after the midweek dialysis session. 2. The 8-zone lung ultrasound method calculates the number of B-line scores. 3. Reduce the dry weight by 500 g if the B-line score is \>0.54/zone (BLS\>5). considered a day one. 4. The dry weight will be reduced only if the arterial blood pressure at the end of the session is BP \>110/60 mmHg and the patient had no hypotension episode during the session. 5. The adjustment of dry weight based on lung ultrasound should not be made on the same day as the standard approach adjustment (Regular monthly clinical standards modification. 6. Check the Blood Pressure 3 times/ day on the non-dialysis following the ultrasound. 7. Check the ambulatory blood pressure for 48 hours (Baseline on day 1 and Follow-up on Day 60). B - Observational Phase= (Day-30) + (Day-45) + (Day-60)\].

Also known as: Dry- Weight modification

Interventional Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic in-center hemodialysis patients for at least three months

You may not qualify if:

• Active Cancer.
• Active infection.
• Patients with pulmonary fibrosis.
• Patients with diffuse pneumonia.
• Patients with frequent hypotension episodes in HD
• Extreme weight gain between dialysis sessions demanding more than 13 ml/kg/h UF rate.

Sponsors & Collaborators

• Hamad Medical Corporation: lead
• Brugmann University Hospital: collaborator

Study Sites (1)

Kaysi Saleh

Brussels, Van Gehuchten, 1020, Belgium

RECRUITING

Related Publications (17)

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  PMID: 15327420 RESULT

• 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 RESULT

• Torino C, Gargani L, Sicari R, Letachowicz K, Ekart R, Fliser D, Covic A, Siamopoulos K, Stavroulopoulos A, Massy ZA, Fiaccadori E, Caiazza A, Bachelet T, Slotki I, Martinez-Castelao A, Coudert-Krier MJ, Rossignol P, Gueler F, Hannedouche T, Panichi V, Wiecek A, Pontoriero G, Sarafidis P, Klinger M, Hojs R, Seiler-Mussler S, Lizzi F, Siriopol D, Balafa O, Shavit L, Tripepi R, Mallamaci F, Tripepi G, Picano E, London GM, Zoccali C. The Agreement between Auscultation and Lung Ultrasound in Hemodialysis Patients: The LUST Study. Clin J Am Soc Nephrol. 2016 Nov 7;11(11):2005-2011. doi: 10.2215/CJN.03890416. Epub 2016 Sep 22.

  PMID: 27660305 RESULT

• Maw AM, Hassanin A, Ho PM, McInnes MDF, Moss A, Juarez-Colunga E, Soni NJ, Miglioranza MH, Platz E, DeSanto K, Sertich AP, Salame G, Daugherty SL. Diagnostic Accuracy of Point-of-Care Lung Ultrasonography and Chest Radiography in Adults With Symptoms Suggestive of Acute Decompensated Heart Failure: A Systematic Review and Meta-analysis. JAMA Netw Open. 2019 Mar 1;2(3):e190703. doi: 10.1001/jamanetworkopen.2019.0703.

  PMID: 30874784 RESULT

• Zoccali C, Tripepi R, Torino C, Bellantoni M, Tripepi G, Mallamaci F. Lung congestion as a risk factor in end-stage renal disease. Blood Purif. 2013;36(3-4):184-91. doi: 10.1159/000356085. Epub 2013 Dec 20.

  PMID: 24496189 RESULT

• Reisinger N, Lohani S, Hagemeier J, Panebianco N, Baston C. Lung Ultrasound to Diagnose Pulmonary Congestion Among Patients on Hemodialysis: Comparison of Full Versus Abbreviated Scanning Protocols. Am J Kidney Dis. 2022 Feb;79(2):193-201.e1. doi: 10.1053/j.ajkd.2021.04.007. Epub 2021 Jun 3.

  PMID: 34090905 RESULT

• Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.

  PMID: 22392031 RESULT

• Saad MM, Kamal J, Moussaly E, Karam B, Mansour W, Gobran E, Abbasi SH, Mahgoub A, Singh P, Hardy R, Das D, Brown C, Kapoor M, Demissie S, Kleiner MJ, El Charabaty E, El Sayegh SE. Relevance of B-Lines on Lung Ultrasound in Volume Overload and Pulmonary Congestion: Clinical Correlations and Outcomes in Patients on Hemodialysis. Cardiorenal Med. 2018;8(2):83-91. doi: 10.1159/000476000. Epub 2017 Nov 29.

  PMID: 29617006 RESULT

• Loutradis C, Papadopoulos CE, Sachpekidis V, Ekart R, Krunic B, Karpetas A, Bikos A, Tsouchnikas I, Mitsopoulos E, Papagianni A, Zoccali C, Sarafidis P. Lung Ultrasound-Guided Dry Weight Assessment and Echocardiographic Measures in Hypertensive Hemodialysis Patients: A Randomized Controlled Study. Am J Kidney Dis. 2020 Jan;75(1):11-20. doi: 10.1053/j.ajkd.2019.07.025. Epub 2019 Nov 12.

  PMID: 31732234 RESULT

• Loutradis C, Sarafidis PA, Ekart R, Papadopoulos C, Sachpekidis V, Alexandrou ME, Papadopoulou D, Efstratiadis G, Papagianni A, London G, Zoccali C. The effect of dry-weight reduction guided by lung ultrasound on ambulatory blood pressure in hemodialysis patients: a randomized controlled trial. Kidney Int. 2019 Jun;95(6):1505-1513. doi: 10.1016/j.kint.2019.02.018. Epub 2019 Mar 5.

  PMID: 31027889 RESULT

• Hoke TS, Douglas IS, Klein CL, He Z, Fang W, Thurman JM, Tao Y, Dursun B, Voelkel NF, Edelstein CL, Faubel S. Acute renal failure after bilateral nephrectomy is associated with cytokine-mediated pulmonary injury. J Am Soc Nephrol. 2007 Jan;18(1):155-64. doi: 10.1681/ASN.2006050494. Epub 2006 Dec 13.

  PMID: 17167117 RESULT

• K/DOQI Workgroup. K/DOQI clinical practice guidelines for cardiovascular disease in dialysis patients. Am J Kidney Dis. 2005 Apr;45(4 Suppl 3):S1-153. No abstract available.

  PMID: 15806502 RESULT

• Assimon MM, Wenger JB, Wang L, Flythe JE. Ultrafiltration Rate and Mortality in Maintenance Hemodialysis Patients. Am J Kidney Dis. 2016 Dec;68(6):911-922. doi: 10.1053/j.ajkd.2016.06.020. Epub 2016 Aug 26.

  PMID: 27575009 RESULT

• Kim TW, Chang TI, Kim TH, Chou JA, Soohoo M, Ravel VA, Kovesdy CP, Kalantar-Zadeh K, Streja E. Association of Ultrafiltration Rate with Mortality in Incident Hemodialysis Patients. Nephron. 2018;139(1):13-22. doi: 10.1159/000486323. Epub 2018 Jan 18.

  PMID: 29402814 RESULT

• Flythe JE, Kimmel SE, Brunelli SM. Rapid fluid removal during dialysis is associated with cardiovascular morbidity and mortality. Kidney Int. 2011 Jan;79(2):250-7. doi: 10.1038/ki.2010.383. Epub 2010 Oct 6.

  PMID: 20927040 RESULT

• 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 RESULT

• Kaysi S, Hamad A, Boulgheraif A, Bonkain F, Libertalis M, Abu Ayyach A, Baz M, Farah I, Ibrahim R, Ateya H, Mathew M, Collart F, Mesquita M, Taghavi M, Alkadi M, Al-Malki H, Nortier J. Lung Ultrasound Guided Management of Pulmonary Congestion in Hemodialysis: A Multicenter Randomized Controlled Trial. Kidney360. 2026 Jan 1;7(1):139-149. doi: 10.34067/KID.0000000873. Epub 2025 Aug 15. No abstract available.

  PMID: 40815555 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Edema

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Hassan A Al-Malki, MD

  Hamad Medical Corporation

  STUDY DIRECTOR

Central Study Contacts

Abdullah I Hamad, MD

CONTACT

+97433486848; ahamad9@hamad.qa

Rania Ibrahim

CONTACT

+97444394808; ribrahim4@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: It is a single-blinded trial as the treatment is blinded by Subjects only, meaning that the type of dry weight modification will not be disclosed to the subject, and they will not know which group he/she will be in at the time of consenting to limit the bias in opinion. The investigator and the research team must know the type of treatment, as the investigator will modify the dry weight according to the treatment group.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Principal Investigation

Model Details: The study will compare two groups according to the dry weight determination method: (1) Control arm- modification of dry weight according to standardized care only. The standard of care to modify dry weight is what nephrologists use actually to define the best theoretical dry weight, including clinical (blood pressure, edema, shortness of breath, lung auscultation, etc.) and laboratory measures (Protein concentration before and after dialysis sessions …). (2) Intervention arm- modify patient's dry weight according to standard of care + B lines score on lung ultrasound BLS obtained after the midweek dialysis session, considered as Day one (Day 1)

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 6, 2024
• Study Start: May 28, 2023
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Every six months.
• Access Criteria: through DropBox, which is a secure server for data storage and transferring to ensure the security of the data, it has a partnership with Microsoft, which allows synchronization speed for large files that improve the upload or download time between the two sites.

Locations

BE (1)