CKD-aP Among Adults on Dialysis in Switzerland (UP-RAISE)

Uremic Pruritus Among Adults on Dialysis in the French Speaking Part of Switzerland

Chronic Kidney Disease Associated Pruritus (CKD-aP) represents a localized or a generalized skin itch, which is a common symptom occurring in end-stage renal disease and dialysis. The prevalence of CKD-aP in adults on dialysis varies between countries ranging between 20-42%. Swiss data on CKD-aP are unfortunately largely lacking, as Switzerland is so far not part of large registries, such as DOPPS.

The aging population, the increase in diabetes (69% by 2030), the increase in hypertension (60% by 2025) and poly-morbidity will probably lead to a rise in the number of patients on dialysis and subsequent CKD-aP.

CKD-aP is associated with sleep disturbances, compromised quality of life, emotional distress, and increased risks of hospitalization and death. Its management lacks approaches that are supported by strong evidence because its pathogenesis remains poorly understood and may be related to an increase in uremic toxins, skin inflammation. In this context, sweat composition deserves more attention.

Aim of the study The aim of the study is to determine the prevalence of CKD-aP in the population on dialysis, the association between CKD-aP and different electrolytes, and the potential role of the composition of sweat in CKD-aP.

Results will be used for building a CKD-aP symptom management program to improve the quality of care of patients on dialysis and will be incorporated in the nursing continuing education program.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Dialysis; Chronic Kidney Diseases Associated Pruritus
• Intervention / Treatment: Other: CKD-aP

• Study Type: Observational
• Enrollment (Actual): 401

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • University of Lausanne Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients on hemodialysis or peritoneal dialysis followed by nephrologists in private and public hospitals of the French speaking Part of Switzerland.

Description

Inclusion Criteria:

• Adult ≥ 18 years old
• Diagnosed with end-stage renal disease and receiving hemodialysis for at least 6 months
• Able to communicate in French or availability of a French-speaking close relative for translation
• Signed informed consent

Additional inclusion criteria for the case-control study outcomes phase 2:

• Reporting moderate to severe CKD-aP for the participant considered as a case
• Reporting no or mild CKD-aP for the participant considered as a control Cases and controls will be matched by age-group, sex, and dialysis modality (hemodialysis or peritoneal dialysis).

Exclusion Criteria:

• Presence of cognitive impairment or cognitive disorder

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of CKD-aP	Evaluation of the presence of CKD-aP. This outcome prevalence will be reported in %.	June 27, 2022- October 31, 2023
Severity of CKD-aP using the Visual Analog Scale	Severity of CKD-aP will be measured using the Visual Analog Scale (VAS) questionnaire. Participants will be asked to rate their maximum pruritus intensity during the last 24 hours. The VAS score ranges from 0 (not itchy) to 10 (extremely itchy); Severity will be classified into five categories: 1) 0 = no pruritus, 2) 0.1-2.9 points = mild pruritus, 3) 3.0-6.9 points = moderate pruritus, 4) 7.0-8.9 points = severe pruritus, and 5) 9.0-10.0 points = very severe pruritus. Higher scores indicate a worse outcome.	June 27, 2022- October 31, 2023
Severity of CKD-aP using the Verbal Rating Scale	Severity of CKD-aP will also be measured using the Verbal Rating Scale (VRS) questionnaire. Participants will be asked to rate their maximum pruritus intensity during the last 24 hours. The VRS is a five-point scale and consists of a list of adjectives describing various levels of symptom intensity (0= no itch, 1= mild itch, 2= moderate itch, 3= severe itch and 4=very severe itch). Higher scores indicate a worse outcome.	June 27, 2022- October 31, 2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sodium level (mmol/l) in sweat	Measurement of sodium (mmol/l) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis. 60 participants (30 cases and 30 controls)	June 27, 2022- October 31, 2023
Chloride level (mmol/l) in sweat	Measurement of chloride (mmol/l) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis. 60 participants (30 cases and 30 controls)	June 27, 2022- October 31, 2023
Potassium level (mmol/l) in sweat	Measurement of potassium (mmol/l) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis. 60 participants (30 cases and 30 controls)	June 27, 2022- October 31, 2023
Calcium level (mg/l) in sweat	Measurement of calcium (mg/l) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis. 60 participants (30 cases and 30 controls)	June 27, 2022- October 31, 2023
Phosphorus level (mg/ml) in sweat	Measurement of phosphorus (mg/ml) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis. 60 participants (30 cases and 30 controls)	June 27, 2022- October 31, 2023
Urea level (mmol/l) in sweat	Measurement of urea (mmol/l) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis. 60 participants (30 cases and 30 controls)	June 27, 2022- October 31, 2023

Collaborators and Investigators

• Sponsor: University of Applied Sciences of Western Switzerland
• Collaborators: University Hospital, Geneva; University of Lausanne Hospitals; Hôpital Fribourgeois; Vifor Pharma; Valais Hospital; eHnv Hospital; Rennaz Hospital; Intercantonal Hospital of Broye; GHOL Nyon Hospital; Cecil Clinic Hirslanden Private Hospital Group; Dialyse Riviera; Reseau Hospitalier Neuchatelois, Service of Nephrology, Neuchâtel

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): October 9, 2023
• Study Completion (Actual): October 9, 2023

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Dialysis; Pruritus
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Skin Manifestations; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Pruritus
• Other Study ID Numbers: 2022-00670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Anonymized Data can be shared upon justified request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No