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

February 28, 2024 updated by: Abdullah Ibrahim Hamad, Hamad Medical Corporation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Abdullah I Hamad, MD
  • Phone Number: +97444394854 +97433486848
  • Email: ahamad9@hamad.qa

Study Contact Backup

Study Locations

  • Belgium
    • Van Gehuchten
      • Bruxelles, Van Gehuchten, Belgium, 1020

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
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)].

Other Names:
  • Dry- Weight modification
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: At baseline and at the end of 2 months follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of utilizing B lines score based additional fluid removal on interdialytic ambulatory blood pressure.
Time Frame: At baseline and at the end of 2 months follow-up
Interdialytic 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
Time Frame: At baseline and at the end of 2 months follow-up
  1. 24-hour ambulatory blood pressure measurement (ABPM) for 44H at day -2 and day 28.
  2. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamad Medical Corporation

Collaborators

Brugmann University Hospital

Investigators

  • Study Director: Hassan A Al-Malki, MD, Hamad Medical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2023

Primary Completion (Estimated)

May 22, 2024

Study Completion (Estimated)

May 22, 2024

Study Registration Dates

First Submitted

February 18, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Estimated)

March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-01-23-035
  • LUSAM-HD (Other Grant/Funding Number: COMITE D'ETHIQUE du CHU BRUGMANN c/o Direction Médicale)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The coded master sheet with all the subject medical history and the lung US results will be sent to the Belgium site 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.

IPD Sharing Time Frame

Every six months.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Disease

Clinical Trials on Intervention Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe