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OpenTrials
Completed

NCT Number: NCT06354842

Measurement of Sweat Sodium Concentration in Patients With Chronic Kidney Disease

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

pilocarpine iontopheresis

Diagnostic Test

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

Primary outcomes

  1. Sweat sodium concentration

    Time frame: Right after study inclusion of patients/subjects

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Application of Pilocarpine Iontophoresis in Patients With Chronic Kidney Disease: a Feasibility Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2024
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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