Chronic Kidney Disease Requiring Chronic DialysisNCT06873880
Integrating BIA and eGFR for Nutritional Status in Hemodialysis Patients
An observational study of Chronic Kidney Disease Requiring Chronic Dialysis, run by University of Tartu at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis
- How many people
- 30 participants
- Where
- 1 siteEstonia
- Study dates
- 10 Feb 2025to 30 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on chronic hemodialysis for at least 6 months
Who may be able to join
- Chronic kidney disease Hemodialysis for at least 6 months
Who cannot join
- Pregnancy Lactation Major second pathology Pacemaker Recent surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Estonia1 site, 1 recruiting
- Recruiting
Institute of Clinical Medicine
Tartu, Tartu, 50406
Külli Kõlvald, MD, +372 5331 8655, kylli.kolvald@kliinikum.ee
Alastair Forbes, MD, +372 5883 0422, alastair.forbes@ut.ee
About this study
Official title: Integrating Bioelectrical Impedance Analysis and Estimated Glomerular Filtration Rate: A Novel Approach to Assessment of Nutritional Status of 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.
Read the 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.
- Keywords
- Dialysis, Bioelectrical impedance, Nutrition, Body composition, Renal impairment
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing hemodialysis at Tartu University Hospital | Bioelectrical impedance analysis Background data and clinical findings related to need for dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between body composition and estimated glomerular filtration rate
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.
Measured: 3 months
Secondary outcomes (3)
Assessment of malnutrition in patients on chronic hemodialysis
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.
Measured: 3 months
Assessment of body composition in patients on chronic hemodialysis
Total body water (ml) derived from BIA will also be compared to the eGFR assessments
Measured: 3 months
Assessment of phase angle in patients on chronic hemodialysis
Phase angle (from BIA) will be compared to the eGFR assessments
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start10 Feb 2025
- Primary completion31 May 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Requiring Chronic DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alastair Forbes, University of Tartu
- Investigators
- Alastair Forbes, MD, Study director, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873880
- Sponsor's protocol ID
- 397/T-10
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pilot study
Publications
Wang K, Zelnick LR, Chertow GM, Himmelfarb J, Bansal N. Body Composition Changes Following Dialysis Initiation and Cardiovascular and Mortality Outcomes in CRIC (Chronic Renal Insufficiency Cohort): A Bioimpedance Analysis Substudy. Kidney Med. 2021 Feb 18;3(3):327-334.e1. doi: 10.1016/j.xkme.2020.12.008. eCollection 2021 May-Jun.
PubMed 34136778Bellafronte NT, Vega-Piris L, Cuadrado GB, Chiarello PG. Performance of Bioelectrical Impedance and Anthropometric Predictive Equations for Estimation of Muscle Mass in Chronic Kidney Disease Patients. Front Nutr. 2021 May 21;8:683393. doi: 10.3389/fnut.2021.683393. eCollection 2021.
PubMed 34095195Guo Y, Zhang M, Ye T, Wang Z, Yao Y. Application of Bioelectrical Impedance Analysis in Nutritional Management of Patients with Chronic Kidney Disease. Nutrients. 2023 Sep 12;15(18):3941. doi: 10.3390/nu15183941.
PubMed 37764725Son WC, Kwon JG, Hong JP, Park CS, Kim SA, Do JH, Cheon H, Gelvosa MN, Suh HS, Jeon JY. Clinical Utility of Bioelectrical Impedance Analysis Parameters for Evaluating Patients with Lower Limb Lymphedema after Lymphovenous Anastomosis. J Reconstr Microsurg. 2023 Mar;39(3):171-178. doi: 10.1055/s-0042-1750126. Epub 2022 Jul 11.
PubMed 35817050La Porta E, Faragli A, Herrmann A, Lo Muzio FP, Estienne L, Nigra SG, Bellasi A, Deferrari G, Ricevuti G, Di Somma S, Alogna A. Bioimpedance Analysis in CKD and HF Patients: A Critical Review of Benefits, Limitations, and Future Directions. J Clin Med. 2024 Oct 30;13(21):6502. doi: 10.3390/jcm13216502.
PubMed 39518641
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Bioelectrical Impedance Analysis and Estimated Glomerular Filtration Rate: A Novel Approach to Assessment of Nutritional Status of Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06873880
- Acronym / sponsor ID
- 397/T-10
- Keywords
- Dialysis, Bioelectrical impedance, Nutrition, Body composition, Renal impairment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing hemodialysis at Tartu University Hospital | – | –Bioelectrical impedance analysis Background data and clinical findings related to need for dialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on chronic hemodialysis for at least 6 months
Key inclusion criteria (1 listed)
- Chronic kidney disease Hemodialysis for at least 6 months
Key exclusion criteria (1 listed)
- Pregnancy Lactation Major second pathology Pacemaker Recent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Assessment of malnutrition in patients on chronic hemodialysis
Time frame: 3 months
Assessment of body composition in patients on chronic hemodialysis
Time frame: 3 months
Assessment of phase angle in patients on chronic hemodialysis
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Background: PubMed 34136778Wang K, Zelnick LR, Chertow GM, Himmelfarb J, Bansal N. Body Composition Changes Following Dialysis Initiation and Cardiovascular and Mortality Outcomes in CRIC (Chronic Renal Insufficiency Cohort): A Bioimpedance Analysis Substudy. Kidney Med. 2021 Feb 18;3(3):327-334.e1. doi: 10.1016/j.xkme.2020.12.008. eCollection 2021 May-Jun.
- Background: PubMed 34095195Bellafronte NT, Vega-Piris L, Cuadrado GB, Chiarello PG. Performance of Bioelectrical Impedance and Anthropometric Predictive Equations for Estimation of Muscle Mass in Chronic Kidney Disease Patients. Front Nutr. 2021 May 21;8:683393. doi: 10.3389/fnut.2021.683393. eCollection 2021.
- Background: PubMed 37764725Guo Y, Zhang M, Ye T, Wang Z, Yao Y. Application of Bioelectrical Impedance Analysis in Nutritional Management of Patients with Chronic Kidney Disease. Nutrients. 2023 Sep 12;15(18):3941. doi: 10.3390/nu15183941.
- Background: PubMed 35817050Son WC, Kwon JG, Hong JP, Park CS, Kim SA, Do JH, Cheon H, Gelvosa MN, Suh HS, Jeon JY. Clinical Utility of Bioelectrical Impedance Analysis Parameters for Evaluating Patients with Lower Limb Lymphedema after Lymphovenous Anastomosis. J Reconstr Microsurg. 2023 Mar;39(3):171-178. doi: 10.1055/s-0042-1750126. Epub 2022 Jul 11.
- Background: PubMed 39518641La Porta E, Faragli A, Herrmann A, Lo Muzio FP, Estienne L, Nigra SG, Bellasi A, Deferrari G, Ricevuti G, Di Somma S, Alogna A. Bioimpedance Analysis in CKD and HF Patients: A Critical Review of Benefits, Limitations, and Future Directions. J Clin Med. 2024 Oct 30;13(21):6502. doi: 10.3390/jcm13216502.
- Individual participant dataSharing planned: Undecided. Pilot study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alastair Forbes, MD study director
University of Tartu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease Requiring Chronic Dialysis, run by University of Tartu at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anum Basit Masters student, BSc (+372 5367 2243, anumbasit.08@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between body composition and estimated glomerular filtration rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06873880, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.