CKD-aP Among Adults on Dialysis in Switzerland

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Kidney Diseases, Dialysis, Chronic Kidney Diseases Associated Pruritus

Intervention / Treatment
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* Other: CKD-aP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: CKD-aP|Identification of CKD-aP prevalence and severity among patients on dialysis.|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease; Dialysis; Pruritus