NCT06798272

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

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 10, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

1.6 years

First QC Date

January 16, 2025

Last Update Submit

January 22, 2025

Conditions

Keywords

hemodialysiswater-electrolyte balancedry body massskinfold thickness

Outcome Measures

Primary Outcomes (1)

  • changes in overhydration

    From enrollment to one week

Study Arms (1)

changes of overhydration during hemodialysis session

EXPERIMENTAL
Procedure: dialysisis with and without glucose in the dialysis

Interventions

there were assessed three consecutive hemodialysis sessions

changes of overhydration during hemodialysis session

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Renal InsufficiencyWater Intoxication

Interventions

Glucose

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPoisoningChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

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

Locations