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Completed

NCT Number: NCT05132036

Lung Ultrasound Assessment of Fluid Overload in Haemodialysis Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. number of patients with fluid overload

    Time frame: one day

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: EP8SH

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2021
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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