Lung Ultrasound Assessment of Fluid Overload in Haemodialysis Patients

NCT05132036 | Completed

• 1 other identifier: PI2021_843_0136
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Ultrasound; Hemodialysis Complication

Keywords

Lung ultrasound; Hemodialysis Complication; hemodialysis ultrafiltration volume

Outcome Measures

Primary Outcomes (1)

• number of patients with fluid overload

  Fluid overloaded are determined by both tecniques : estimated fluid overload and lung ultrasound measured fluid overload

  one day

Interventions

lung ultrasound OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 23, 2021
• Study Start: November 9, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)