NCT06354842

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

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 5, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

2.2 years

First QC Date

April 3, 2024

Last Update Submit

April 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sweat sodium concentration

    Sodium concentration of induced sweat by pilocarpine iontopheresis in mmol/L

    Right after study inclusion of patients/subjects

Study Arms (8)

Control

Healthy control subjects

Diagnostic Test: pilocarpine iontopheresis

CKDI

Patients with chronic kidney disease G1

Diagnostic Test: pilocarpine iontopheresis

CKDII

Patients with chronic kidney disease G2

Diagnostic Test: pilocarpine iontopheresis

CKDIIIa

Patients with chronic kidney disease G3a

Diagnostic Test: pilocarpine iontopheresis

CKDIIIb

Patients with chronic kidney disease G3b

Diagnostic Test: pilocarpine iontopheresis

CKDIV

Patients with chronic kidney disease G4

Diagnostic Test: pilocarpine iontopheresis

CKDV

Patients with chronic kidney disease G5

Diagnostic Test: pilocarpine iontopheresis

CKDVd

Patients with chronic kidney disease G5 receiving hemodialysis

Diagnostic Test: pilocarpine iontopheresis

Interventions

Application of pilocarpine on the skin of the patients/subjects to induce sweat production to analyse sweat sodium concentration via flame photometry

CKDICKDIICKDIIIaCKDIIIbCKDIVCKDVCKDVdControl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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)

You may qualify if:

  • Completed 18th year of life and the ability and willingness to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Johannes Kovarik, MD, PhD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical resident & PhD student

Study Record Dates

First Submitted

April 3, 2024

First Posted

April 9, 2024

Study Start

October 5, 2018

Primary Completion

December 11, 2020

Study Completion

December 11, 2020

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations