protocolSection identificationModule nctId: NCT06296160, orgStudyIdInfo id: MRC-01-23-035, secondaryIdInfos id: LUSAM-HD, type: OTHER_GRANT, domain: COMITE D'ETHIQUE du CHU BRUGMANN c/o Direction Médicale, briefTitle: A Simplified Lung Ultrasound Guided Management Protocol Of Pulmonary Congestion in Hemodialysis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-28, primaryCompletionDateStruct date: 2024-05-22, completionDateStruct date: 2024-05-22, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Hamad Medical Corporation, class: INDUSTRY, collaborators name: Brugmann University Hospital, descriptionModule briefSummary: 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., conditionsModule conditions: End Stage Renal Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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), primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: 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., whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Intervention Group, outcomesModule primaryOutcomes measure: 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, secondaryOutcomes measure: The impact of utilizing B lines score based additional fluid removal on interdialytic ambulatory blood pressure., secondaryOutcomes measure: The impact of utilizing B lines score based additional fluid removal on intradialytic ambulatory blood pressure, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kaysi Saleh, status: RECRUITING, city: Bruxelles, state: Van Gehuchten, zip: 1020, country: Belgium, contacts name: Nortier Joelle, PHD, role: CONTACT, phone: +33643250634, email: saleh.kaysi@chu-brugmann.be, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False