Monitoring of Hydration Status in Chronic Hemodialysis Patients

January 22, 2025 updated by: Michal Nowicki, Medical University of Lodz

Measurement of Skinfold Thickness in Subscapular Area to Monitor Hydration Status in Chronic Hemodialysis Patients

Background Maintaining fluid balance is one of major challenges of the dialysis therapy. It includes, in particular, the management of "dry body mass". We postulated that simple measurement of subscapular skinfold thickness before and after hemodialysis could help monitor hydration status in chronic dialysis patients.

Aim of the study The aim of the study was to compare the conventional methods of monitoring hydration status during hemodialysis with an assessment of skin fold thickness.

Materials and Methods 50 participants (21 F, 29 M; age 60 ±15 years) were enrolled. Directly before the hemodialysis session the following parameters were measured: body composition with bioimpedance spectroscopy, skinfold thickness in subscapular area with standardized caliper and blood tests: blood count, urea, n-terminal pro B-type natriuretic peptide (nt-proBNP) and pro-adrenomedullin (pro-ADM). The procedures were repeated at the end of three consecutive hemodialysis sessions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lodz, Poland, 92-213
        • Central University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • chronic hemodialysis for at least 3 months

Exclusion Criteria:

  • severe mental disabilities, poor compliance, any acute infection, instability of the cardiovascular hemodynamic condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: changes of overhydration during hemodialysis session
Procedure: dialysisis with and without glucose in the dialysis
there were assessed three consecutive hemodialysis sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in overhydration
Time Frame: From enrollment to one week
From enrollment to one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2021

Primary Completion (Actual)

May 10, 2023

Study Completion (Actual)

March 15, 2024

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 163/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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