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NCT Number: NCT06873880

Integrating BIA and eGFR for Nutritional Status in Hemodialysis Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Chronic kidney disease Hemodialysis for at least 6 months

Exclusion criteria

Pregnancy Lactation Major second pathology Pacemaker Recent surgery

Treatment and study plan

Primary outcomes

  1. Correlation between body composition and estimated glomerular filtration rate

    Time frame: 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 outcomes

  1. Assessment of malnutrition in patients on chronic hemodialysis

    Time frame: 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.

  2. Assessment of body composition in patients on chronic hemodialysis

    Time frame: 3 months

    Total body water (ml) derived from BIA will also be compared to the eGFR assessments

  3. Assessment of phase angle in patients on chronic hemodialysis

    Time frame: 3 months

    Phase angle (from BIA) will be compared to the eGFR assessments

Study contacts

Contact information is provided by the study sponsor or research team.

Alastair Forbes, MD

CONTACT

[email protected]

+372 5883 0422

Anum Basit Masters student, BSc

CONTACT

[email protected]

+372 5367 2243

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Registry information

Official study title

Integrating Bioelectrical Impedance Analysis and Estimated Glomerular Filtration Rate: A Novel Approach to Assessment of Nutritional Status of Hemodialysis Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Mar 13, 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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