Monitoring of Hydration Status in Chronic Hemodialysis Patients
Measurement of Skinfold Thickness in Subscapular Area to Monitor Hydration Status in Chronic Hemodialysis Patients
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2024
CompletedFirst Submitted
Initial submission to the registry
January 16, 2025
CompletedFirst Posted
Study publicly available on registry
January 29, 2025
CompletedJanuary 29, 2025
January 1, 2025
1.6 years
January 16, 2025
January 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changes in overhydration
From enrollment to one week
Study Arms (1)
changes of overhydration during hemodialysis session
EXPERIMENTALInterventions
there were assessed three consecutive hemodialysis sessions
Eligibility Criteria
You may qualify if:
- chronic hemodialysis for at least 3 months
You may not qualify if:
- severe mental disabilities, poor compliance, any acute infection, instability of the cardiovascular hemodynamic condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Central University Hospital
Lodz, 92-213, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor MD
Study Record Dates
First Submitted
January 16, 2025
First Posted
January 29, 2025
Study Start
October 10, 2021
Primary Completion
May 10, 2023
Study Completion
March 15, 2024
Last Updated
January 29, 2025
Record last verified: 2025-01