Integrating BIA and eGFR for Nutritional Status in Hemodialysis Patients

Recruiting

• Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

• Registration Number: NCT06873880
• Lead Sponsor: University of Tartu

Brief Summary

This study looks at how measurements of body composition from Bioelectrical Impedance Analysis (BIA) and estimates of kidney function (eGFR) can be applied together to better assess the health of people on hemodialysis. Many dialysis patients struggle with malnutrition, muscle loss, and fluid imbalances, but current assessment methods rely on unsophisticated tests and observations. By combining BIA and eGFR, this study aims to provide a more accurate and non-invasive way to monitor nutrition and overall health, which could lead to better treatment decisions and improved patient outcomes.

Detailed Description

The primary objective of the study is to assess the correlation between Bioelectrical Impedance Analysis (BIA) derived body composition parameters (e.g.fat mass, fat-free mass, total body water, phase angle) and estimated glomerular filtration rate (eGFR) in hemodialysis patients.

The study will investigate how BIA and eGFR can be used together to more effectively monitor nutritional interventions in hemodialysis patients. The study will also assess the prevalence of malnutrition and protein-energy wasting (PEW) in the study population using BIA and eGFR data.

Hemodialysis patients often suffer from complex nutritional problems due to the interplay between renal function, protein-energy wasting and fluid management. Current nutritional assessments in hemodialysis patients are limited, most of which rely on clinical observations or quite basic biochemical tests. A more comprehensive, non-invasive approach is needed to assess both nutritional status and fluid balance. The study will determine whether comparing BIA metrics with eGFR provides a better picture of a patient's nutritional and renal health, which could then improve patient outcomes and dialysis management.

Malnutrition, fluid imbalances, and protein-energy wasting (PEW) are common in patients undergoing hemodialysis due to chronic kidney disease (CKD) and the effects of dialysis therapy. Nutritional status is a critical factor influencing patient outcomes in CKD, but is often under-monitored.

Traditional methods of assessing renal function, such as estimated glomerular filtration rate (eGFR), provide insight into renal health but do not directly measure body composition or nutritional status. Bioelectrical Impedance Analysis (BIA), in contrast, provides a detailed picture of body composition, including fat mass, fat-free mass, total body water, and phase angle. The aim of this study is to investigate the relationship between BIA-derived markers of nutritional status and eGFR to assess their combined utility in assessing nutritional status in hemodialysis patients.

Study Timeline

• Study Start: 2025-02-10
• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-05-31
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Chronic kidney disease Hemodialysis for at least 6 months

Exclusion Criteria

Pregnancy Lactation Major second pathology Pacemaker Recent surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between body composition and estimated glomerular filtration rate	3 months	The primary outcome measure of this study is the correlation between body composition as fat free mass (kg) derived from Bioelectrical Impedance Analysis (BIA) and estimated glomerular filtration rate (eGFR) (ml/minute) in hemodialysis patients.

Secondary Outcome Measures

Name	Time	Method
Assessment of malnutrition in patients on chronic hemodialysis	3 months	The study assesses the prevalence of malnutrition and protein-energy wasting (PEW) in the study population using fat-free mass (kg) from BIA and eGFR (ml/minute) data.
Assessment of body composition in patients on chronic hemodialysis	3 months	Total body water (ml) derived from BIA will also be compared to the eGFR assessments
Assessment of phase angle in patients on chronic hemodialysis	3 months	Phase angle (from BIA) will be compared to the eGFR assessments

Trial Locations

Locations (1)

Institute of Clinical Medicine; 🇪🇪 Tartu, Tartumaa, Estonia