Lung Ultrasound Assessment of Fluid Overload in Haemodialysis Patients

NCT ID: NCT05132036

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-09

Study Completion Date

2022-06-01

Brief Summary

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Determination of the hemodialysis ultrafiltration volume is guided by the clinician's estimate of dry weight. A poor estimate of this dry weight may result in insufficient fluid depletion causing a state of volume overload, which may be associated with long-term left ventricular failure, high blood pressure and excess of mortality. The diagnosis of fluid overload in haemodialysis patient is routinely based on clinical examination which consists of cardiopulmonary auscultation and edema palpation of limb member. Clinical examination can be completed by paraclinical examinations, and bioimpedance is an objective tool that assess fluid overload state. This test provides an individualized hydration status and fluid overload based on normal extracellular volume considering body composition. Echocardiography allows an accurate assessment of blood volume status by simultaneous studying left ventricular filling pressures, systolic pulmonary artery pressure and the diameter of the inferior vena cava. Lung ultrasound analyses the B-lines defined as artefactual images resulting from contact between air in "alveoli" and water in "septa". It can estimate pulmonary congestion. The aim of the study is to evaluate the lung ultrasound using "8 sites" score accuracy for estimating fluid overload of patients before hemodialysis session.

Detailed Description

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Conditions

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Lung Ultrasound Hemodialysis Complication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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lung ultrasound

Subjects are enrolled during their usual session in the hemodialysis unit of the Amiens University Hospital. Before starting the hemodialysis, lung ultrasound according to the "8 sites" score and a measure of bioimpedance will be performed in dorsal decubitus. In a 2nd time, an echocardiography is realized. During haemodialysis session, biological analysis and clinical score will be assessed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age over 18 years old
* patients on hemodialysis for more than 3 months;
* patients without cardiological or infectious event for at least 3 months;
* patients having at least 2 dialysis session per week;
* patients affiliated with a health insurance plan;
* patients having signed an informed consent.

Exclusion Criteria

* Pulmonary fibrosis or active lung disease;
* residual diuresis over 500 mL per day;
* body mass index (BMI) \< 21 and \> 28 Kg/m²;
* medical history of major amputation (subgonal or transfemoral);
* pacemaker carrier;
* patients with orthopedic prosthesis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

Other Identifiers

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PI2021_843_0136

Identifier Type: -

Identifier Source: org_study_id

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