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| Name | Class |
|---|---|
| University of Lausanne Hospitals | OTHER |
| Hôpital Fribourgeois | OTHER |
| University Hospital, Geneva | OTHER |
| Valais Hospital |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-aP | Other | Identification of CKD-aP prevalence and severity among patients on dialysis. |
| 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 |
| 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 |
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Inclusion Criteria:
Additional inclusion criteria for the case-control study outcomes phase 2:
Exclusion Criteria:
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Adult patients on hemodialysis or peritoneal dialysis followed by nephrologists in private and public hospitals of the French speaking Part of Switzerland.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Lausanne Hospitals | Lausanne | Canton of Vaud | 1011 | Switzerland |
Anonymized Data can be shared upon justified request.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| UNKNOWN |
| eHnv Hospital | UNKNOWN |
| Rennaz Hospital | UNKNOWN |
| Intercantonal Hospital of Broye | UNKNOWN |
| GHOL Nyon Hospital | UNKNOWN |
| Dialyse Riviera | UNKNOWN |
| Cecil Clinic Hirslanden Private Hospital Group | UNKNOWN |
| Vifor Pharma | INDUSTRY |
| Réseau Hospitalier Neuchâtelois | OTHER |
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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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |