Lung Ultrasound Assessment of Fluid Overload in Haemodialysis Patients (EP8SH)

Lung Ultrasound Assessment of Fluid Overload in Haemodialysis Patients Using 8 Sites Score

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Complication; Lung Ultrasound
• Intervention / Treatment: Other: lung ultrasound

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients with fluid overload	Fluid overloaded are determined by both tecniques : estimated fluid overload and lung ultrasound measured fluid overload	one day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 9, 2021
• Primary Completion (ACTUAL): June 1, 2022
• Study Completion (ACTUAL): June 1, 2022

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (ACTUAL): November 23, 2021

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Lung ultrasound; Hemodialysis Complication; hemodialysis ultrafiltration volume
• Other Study ID Numbers: PI2021_843_0136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No