Chronic Kidney DiseasesNCT06354842
Measurement of Sweat Sodium Concentration in Patients With Chronic Kidney Disease
An observational study of Chronic Kidney Diseases, run by Medical University of Vienna at 1 site in Austria.
Trial summary
It has been shown that excretion of sodium and water through the skin in the form of sweat represents a regulatory mechanism of electrolyte- and fluid balance. Since patients with chronic kidney disease (CKD) exhibit increased skin sodium content, we investigated the feasibility of sweat testing as a novel… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- pilocarpine iontopheresis
- How many people
- 64 participants
- Where
- 1 siteAustria
- Study dates
- 5 Oct 2018to 11 Dec 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy controls older than 18 years old. Patients older than 18 years old with all grades of Chronic Kidney Disease (also patients receiving hemodialysis)
Who may be able to join
- Completed 18th year of life and the ability and willingness to provide informed consent
Who cannot join
- General exclusion criteria were signs of acute infection, clinical signs of kidney graft rejection or pregnancy. Exclusion criteria for the healthy controls were pregnancy or the presence of chronic metabolic, renal, cardiovascular, or rheumatologic conditions, hypertension, chronic or recent intake (8 weeks prior to testing) of psychiatric or antihypertensive medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Pilocarpine Iontophoresis in Patients With Chronic Kidney Disease: a Feasibility Study
It has been shown that excretion of sodium and water through the skin in the form of sweat represents a regulatory mechanism of electrolyte- and fluid balance. Since patients with chronic kidney disease (CKD) exhibit increased skin sodium content, we investigated the feasibility of sweat testing as a novel experimental tool to a more complete assessment of fluid- and sodium homeostasis.
In this cross-sectional feasibility study, we applied pilocarpine iontophoresis to induce sweat testing in 58 patients across various stages of CKD including patients after kidney transplantation as well as a healthy control cohort (n=6) to investigate possible effects of CKD and transplantation status on sweat rate and sodium concentration. Due to non-linear relationships, we modeled our data using polynomial regression.
Read more
Decline of kidney function showed a significant association with lower sweat rates: adj R²= 0.2278, F(2, 61) = 10.29, p = 0.000141. Sweat sodium concentrations were increased in moderate CKD, however this effect was lost in end stage renal disease: adj R² = 0.3701, F(4, 59) = 10.26, p = 2.261e-06. We observed higher sweat weight in males compared to females.
Diagnostic sweat analysis represents an innovative and promising noninvasive option for more thorough investigation of sodium- and fluid homeostasis in CKD patients. Lower sweat rates and higher sweat sodium concentrations represent a unique feature of CKD patients with potential therapeutic implications.
- Conditions
- Chronic Kidney Diseases
- Being tested
- pilocarpine iontopheresis
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pilocarpine iontopheresisDiagnostic test
Application of pilocarpine on the skin of the patients/subjects to induce sweat production to analyse sweat sodium concentration via flame photometry
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy control subjects Receives: Diagnostic Test: pilocarpine iontopheresis | |
| CKDI | Patients with chronic kidney disease G1 Receives: Diagnostic Test: pilocarpine iontopheresis | |
| CKDII | Patients with chronic kidney disease G2 Receives: Diagnostic Test: pilocarpine iontopheresis | |
| CKDIIIa | Patients with chronic kidney disease G3a Receives: Diagnostic Test: pilocarpine iontopheresis | |
| CKDIIIb | Patients with chronic kidney disease G3b Receives: Diagnostic Test: pilocarpine iontopheresis | |
| CKDIV | Patients with chronic kidney disease G4 Receives: Diagnostic Test: pilocarpine iontopheresis | |
| CKDV | Patients with chronic kidney disease G5 Receives: Diagnostic Test: pilocarpine iontopheresis | |
| CKDVd | Patients with chronic kidney disease G5 receiving hemodialysis Receives: Diagnostic Test: pilocarpine iontopheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sweat sodium concentration
Sodium concentration of induced sweat by pilocarpine iontopheresis in mmol/L
Measured: Right after study inclusion of patients/subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start5 Oct 2018
- Primary completion11 Dec 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarik Shoumariyeh, Medical University of Vienna
- Investigators
- Johannes Kovarik, MD, PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354842
- Sponsor's protocol ID
- 12345678
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shoumariyeh T, Logar F, Helk O, Hofer J, Schmetterer KG, Mersi B, Gruber S, Saemann MD, Kaltenecker CC, Kovarik JJ. Decline of kidney function is associated with lower sweat weight in patients with chronic kidney disease. Sci Rep. 2025 Jul 2;15(1):22518. doi: 10.1038/s41598-025-05855-8.
PubMed 40596012
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Pilocarpine Iontophoresis in Patients With Chronic Kidney Disease: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06354842
- Acronym / sponsor ID
- 12345678
- Conditions
- Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 9 Apr 2024 (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.
It has been shown that excretion of sodium and water through the skin in the form of sweat represents a regulatory mechanism of electrolyte- and fluid balance. Since patients with chronic kidney disease (CKD) exhibit increased skin sodium content, we investigated the feasibility of sweat testing as a novel experimental tool to a more complete assessment of fluid- and sodium homeostasis.
In this cross-sectional feasibility study, we applied pilocarpine iontophoresis to induce sweat testing in 58 patients across various stages of CKD including patients after kidney transplantation as well as a healthy control cohort (n=6) to investigate possible effects of CKD and transplantation status on sweat rate and sodium concentration. Due to non-linear relationships, we modeled our data using polynomial regression.
Decline of kidney function showed a significant association with lower sweat rates: adj R²= 0.2278, F(2, 61) = 10.29, p = 0.000141. Sweat sodium concentrations were increased in moderate CKD, however this effect was lost in end stage renal disease: adj R² = 0.3701, F(4, 59) = 10.26, p = 2.261e-06. We observed higher sweat weight in males compared to females.
Diagnostic sweat analysis represents an innovative and promising noninvasive option for more thorough investigation of sodium- and fluid homeostasis in CKD patients. Lower sweat rates and higher sweat sodium concentrations represent a unique feature of CKD patients with potential therapeutic implications.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: pilocarpine iontopheresisHealthy control subjects |
| CKDI | – | Diagnostic Test: pilocarpine iontopheresisPatients with chronic kidney disease G1 |
| CKDII | – | Diagnostic Test: pilocarpine iontopheresisPatients with chronic kidney disease G2 |
| CKDIIIa | – | Diagnostic Test: pilocarpine iontopheresisPatients with chronic kidney disease G3a |
| CKDIIIb | – | Diagnostic Test: pilocarpine iontopheresisPatients with chronic kidney disease G3b |
| CKDIV | – | Diagnostic Test: pilocarpine iontopheresisPatients with chronic kidney disease G4 |
| CKDV | – | Diagnostic Test: pilocarpine iontopheresisPatients with chronic kidney disease G5 |
| CKDVd | – | Diagnostic Test: pilocarpine iontopheresisPatients with chronic kidney disease G5 receiving hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy controls older than 18 years old. Patients older than 18 years old with all grades of Chronic Kidney Disease (also patients receiving hemodialysis)
Key inclusion criteria (1 listed)
- Completed 18th year of life and the ability and willingness to provide informed consent
Key exclusion criteria (1 listed)
- General exclusion criteria were signs of acute infection, clinical signs of kidney graft rejection or pregnancy. Exclusion criteria for the healthy controls were pregnancy or the presence of chronic metabolic, renal, cardiovascular, or rheumatologic conditions, hypertension, chronic or recent intake (8 weeks prior to testing) of psychiatric or antihypertensive medication.
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 |
|---|---|---|
| pilocarpine iontopheresisApplication of pilocarpine on the skin of the patients/subjects to induce sweat production to analyse sweat sodium concentration via flame photometry | Diagnostic test | CKDI, CKDII, CKDIIIa, CKDIIIb, CKDIV, CKDV, CKDVd, Control |
Primary outcome
Sweat sodium concentration
Time frame: Right after study inclusion of patients/subjects
Sodium concentration of induced sweat by pilocarpine iontopheresis in mmol/L
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 9 Apr 2024.
- Derived from this study: PubMed 40596012Shoumariyeh T, Logar F, Helk O, Hofer J, Schmetterer KG, Mersi B, Gruber S, Saemann MD, Kaltenecker CC, Kovarik JJ. Decline of kidney function is associated with lower sweat weight in patients with chronic kidney disease. Sci Rep. 2025 Jul 2;15(1):22518. doi: 10.1038/s41598-025-05855-8.
- 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.
Johannes Kovarik, MD, PhD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Medical University of Vienna at 1 site in Austria.
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 9 Apr 2024. 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 Austria. 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?
Sweat sodium concentration (time frame: Right after study inclusion of patients/subjects). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06354842, which also lists 1 linked publication.
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 9 Apr 2024.