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Clinical Trials/NCT05132036
NCT05132036
Completed
Not Applicable

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

Centre Hospitalier Universitaire, Amiens1 site in 1 country46 target enrollmentNovember 9, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Ultrasound
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
46
Locations
1
Primary Endpoint
number of patients with fluid overload
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 9, 2021
End Date
June 1, 2022
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Study Sites (1)

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