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

End Stage Renal Disease Clinical Trial

Official title:

Role of Lung Ultrasound in the Assessment and Management of Pulmonary Congestion in Chronic Hemodialysis Patients: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296160
• Other study ID #: MRC-01-23-035
• Secondary ID: LUSAM-HD
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2023
• Est. completion date: May 22, 2024

Study information

• Verified date: February 2024
• Source: Hamad Medical Corporation
• Contact: Abdullah I Hamad, MD
• Phone: +97433486848
• Email: ahamad9[@]hamad.qa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The classic treatment program for hemodialysis patients includes three sessions per week on fixed days (Monday-Wednesday-Friday or Tuesday-Thursday-Saturday or Sunday). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 22, 2024
• Est. primary completion date: May 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• Intervention Group
A- (Intervention Phase= (Day-1) + (Day-15) Obtain a lung ultrasound after the midweek dialysis session. The 8-zone lung ultrasound method calculates the number of B-line scores. Reduce the dry weight by 500 g if the B-line score is >0.54/zone (BLS>5). considered a day one. 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. 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. Check the Blood Pressure 3 times/ day on the non-dialysis following the ultrasound. 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)].

Locations

Country	Name	City	State
Belgium	Kaysi Saleh	Bruxelles	Van Gehuchten

Sponsors (2)

Lead Sponsor	Collaborator
Hamad Medical Corporation	Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. d — View Citation

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. — View Citation

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. — View Citation

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 Hemodialys — View Citation

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 — View Citation

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 he — View Citation

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 Sugg — View Citation

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 — View Citation

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 Co — View Citation

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. — View Citation

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, Wi — View Citation

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, Hoppma — View Citation

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: — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The impact of utilizing B lines score based additional fluid removal on interdialytic ambulatory blood pressure.	Interdialytic blood pressure	At baseline and at the end of 2 months follow-up
Secondary	The impact of utilizing B lines score based additional fluid removal on intradialytic ambulatory blood pressure	24-hour ambulatory blood pressure measurement (ABPM) for 44H at day -2 and day 28.; Ambulatory home blood pressure by using a standard blood pressure machine at days (2, 9, 16, 23, 31)	At baseline and at the end of 2 months follow-up