NCT06873880

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

March 4, 2025

Last Update Submit

March 10, 2025

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

DialysisBioelectrical impedanceNutritionBody compositionRenal impairment

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (3)

  • Assessment of malnutrition in patients on chronic hemodialysis

    3 months

  • Assessment of body composition in patients on chronic hemodialysis

    3 months

  • Assessment of phase angle in patients on chronic hemodialysis

    3 months

Study Arms (1)

Patients undergoing hemodialysis at Tartu University Hospital

Bioelectrical impedance analysis Background data and clinical findings related to need for dialysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients on chronic hemodialysis for at least 6 months

You may qualify if:

  • Chronic kidney disease Hemodialysis for at least 6 months

You may not qualify if:

  • Pregnancy Lactation Major second pathology Pacemaker Recent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Clinical Medicine

Tartu, Tartu, 50406, Estonia

RECRUITING

Related Publications (5)

  • 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.

    PMID: 34136778BACKGROUND

  • Bellafronte 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.

    PMID: 34095195BACKGROUND

  • Guo 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.

    PMID: 37764725BACKGROUND

  • Son 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.

    PMID: 35817050BACKGROUND

  • La 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.

    PMID: 39518641BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Alastair Forbes, MD

    University of Tartu

    STUDY DIRECTOR

Central Study Contacts

Anum Basit Masters student, BSc

CONTACT

+372 5367 2243anumbasit.08@gmail.com

Alastair Forbes, MD

CONTACT

+372 5883 0422alastair.forbes@ut.ee

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 13, 2025

Study Start

February 10, 2025

Primary Completion

May 31, 2025

Study Completion

July 30, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

ES(1)