A Simplified Lung Ultrasound Guided Management Protocol Of Pulmonary Congestion in Hemodialysis
NCT ID: NCT06296160
Last Updated: 2024-03-06
Study Results
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Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-05-28
2024-05-22
Brief Summary
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Detailed Description
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Hemodialysis patients with end-stage renal disease often develop fluid overload between dialysis sessions due to decreased diuresis or anuria. This overload is manifested by pulmonary congestion, which is an independent risk factor for morbidity and mortality from cardiovascular events in these patients. Studies show pulmonary congestion is not always associated with increased left ventricular filling pressure. Patients with end-stage renal disease also have impaired capillary permeability secondary to the dialysis filters used (synthetic membranes) and uremic syndromes, which increases their risk of cardiopulmonary complications. In addition, some experimental studies show that inflammatory mechanisms can also cause capillary changes and increase the risk of pulmonary edema in patients with end-stage renal disease with fluid overload. Evaluating fluid overload and estimating the dry weight of hemodialysis patients.
According to conventional methods, namely pulmonary auscultation, chest radiography, cardiac ultrasound, and blood pressure measurement, this represents a real challenge for clinical nephrologists. Hyper- or hypo-hydration in hemodialysis patients, especially if it persists over time, is linked to adverse cardiovascular consequences. The investigators currently know that this increase in extravascular fluid in the lungs creates an air-liquid interface that induces an ultrasound artifact in continuous lines called B-lines, which ultrasound machines can detect. It has been shown that the presence of these B-lines alone in hemodialysis patients is an independent risk factor for mortality and cardiovascular events. Their sensitivity is high and can be detected even at the subclinical stage. Similarly, in hemodialysis patients with high blood pressure, the modification of dry weight according to these B-lines has demonstrated a beneficial effect on blood pressure control and cardiac parameters. It should be noted that these B-lines are not specific for water overload and can be the consequence of several pathologies, such as interstitial pneumonia or diffuse pulmonary fibrosis. Lung ultrasound is a new diagnostic approach validated in the assessment of pulmonary congestion. According to recent preliminary reports, it would allow a better estimate of volume expansion and, therefore, a better assessment of dry weight in chronic hemodialysis patients. However, little evidence compares this novel approach to conventional standardized approaches. No study has defined the best moment to do a lung ultrasound to obtain the most reliable pulmonary congestion level. The investigators did this in our pilot study and concluded that the best moment was after the second dialysis session. Based on that, and in order to establish a management and monitoring protocol, the study aimed to show that reducing dry weight. According to lung ultrasound at that particular moment, it is the best way to manage pulmonary congestion in this population. Dialysis service in Qatar is provided by Hamad Medical Corporation facilities. The investigators have seven units providing ambulatory dialysis care. Currently, The investigators have about 1000 hemodialysis (HD) patients.
The largest center with over 500 patients is Fahad Bin Jassim Kidney Center (FBJKC). Our current practice is to estimate dry weight on a monthly basis during the monthly evaluation of HD patients by our nephrologist. This evaluation depends on physical examination, blood pressure, and other clinical parameters. Sometimes, it is very difficult to estimate the dry weight (obesity, bedbound or wheelchair-dependent patients, congestive heart failure, etc.). Introducing new technology to guide the estimation of dry weight provides great service to our HD patients. It can help in estimating dry weight, especially in difficult cases. Lung ultrasound to evaluate congestion is a newly introduced technology to help estimate dry weight. Implementing this technology might offer valued service to improve care to our HD patients in Qatar. I want to highlight the importance of this study to our dialysis service in Qatar. In addition to the specified novel approach mentioned in the methods and outcomes, the investigators have many goals to serve dialysis services in Qatar. The investigators will introduce Lung US volume assessment (currently not done) with the training needed and validate the best way of utilizing it to serve our patients. The investigators will also introduce ambulatory home blood pressure measurement (currently not done in dialysis) with all the training needed for our service and the best way to apply it. This study has scientific and practical values on the research ground with the expected immediate impact on our dialysis service.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
(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)
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Interventional Arm
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).
Intervention Group
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)\].
Control Arm
* 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).
No interventions assigned to this group
Interventions
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Intervention Group
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)\].
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
19 Years
ALL
No
Sponsors
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Brugmann University Hospital
OTHER
Hamad Medical Corporation
INDUSTRY
Responsible Party
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Abdullah Ibrahim Hamad
Lead Principal Investigation
Principal Investigators
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Hassan A Al-Malki, MD
Role: STUDY_DIRECTOR
Hamad Medical Corporation
Locations
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Kaysi Saleh
Brussels, Van Gehuchten, Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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Shoji T, Tsubakihara Y, Fujii M, Imai E. Hemodialysis-associated hypotension as an independent risk factor for two-year mortality in hemodialysis patients. Kidney Int. 2004 Sep;66(3):1212-20. doi: 10.1111/j.1523-1755.2004.00812.x.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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LUSAM-HD
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MRC-01-23-035
Identifier Type: -
Identifier Source: org_study_id
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