HemodialysisNCT06798272
Monitoring of Hydration Status in Chronic Hemodialysis Patients
A study testing dialysisis with and without glucose in the dialysis in people with Hemodialysis and Kidney Failure, run by Medical University of Lodz at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Kidney Failure, Overhydration
- What is being tested?
- dialysisis with and without glucose in the dialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 10 Oct 2021to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- chronic hemodialysis for at least 3 months
Who cannot join
- severe mental disabilities, poor compliance, any acute infection, instability of the cardiovascular hemodynamic condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hemodialysis, Kidney Failure, Overhydration
- Being tested
- dialysisis with and without glucose in the dialysis
- Keywords
- hemodialysis, water-electrolyte balance, dry body mass, skinfold thickness
- Medical subject headings
- Renal Insufficiency, Water Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dialysisis with and without glucose in the dialysisProcedure or surgery
there were assessed three consecutive hemodialysis sessions
| Study group | Role | What they receive |
|---|---|---|
| changes of overhydration during hemodialysis session | Experimental | Not described Receives: Procedure: dialysisis with and without glucose in the dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in overhydration
Measured: From enrollment to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start10 Oct 2021
- Primary completion10 May 2023
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Nowicki, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798272
- Sponsor's protocol ID
- 163/20
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Skinfold Thickness in Subscapular Area to Monitor Hydration Status in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06798272
- Acronym / sponsor ID
- 163/20
- Conditions
- Hemodialysis, Kidney Failure, Overhydration
- Keywords
- hemodialysis, water-electrolyte balance, dry body mass, skinfold thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 29 Jan 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| changes of overhydration during hemodialysis session | Experimental | Procedure: dialysisis with and without glucose in the dialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic hemodialysis for at least 3 months
Key exclusion criteria (1 listed)
- severe mental disabilities, poor compliance, any acute infection, instability of the cardiovascular hemodynamic condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dialysisis with and without glucose in the dialysisthere were assessed three consecutive hemodialysis sessions | Procedure or surgery | changes of overhydration during hemodialysis session |
Primary outcome
changes in overhydration
Time frame: From enrollment to one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dialysisis with and without glucose in the dialysis in people with Hemodialysis and Kidney Failure, run by Medical University of Lodz at 1 site in Poland.
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: finished, as of the sponsor's last update on 29 Jan 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in overhydration (time frame: From enrollment to one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2025.