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

NCT06296160 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-06

No results posted yet for this study

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

Interventions

OTHER

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)\].

Sponsors & Collaborators

  • Brugmann University Hospital

    collaborator OTHER

  • Hamad Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Hassan A Al-Malki, MD · Hamad Medical Corporation

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-28
Primary Completion
2024-05-22
Completion
2024-05-22

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06296160 on ClinicalTrials.gov