CKD-aP Among Adults on Dialysis in Switzerland

Chronic Kidney Diseases Clinical Trial

— UP-RAISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05415969
• Other study ID #: 2022-00670
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: October 9, 2023

Study information

• Verified date: November 2023
• Source: University of Applied Sciences of Western Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: October 9, 2023
• Est. primary completion date: October 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Dialysis
• Kidney Diseases
• Pruritus
• Renal Insufficiency, Chronic

Intervention

Other:
• CKD-aP
Identification of CKD-aP prevalence and severity among patients on dialysis.

Locations

Country	Name	City	State
Switzerland	University of Lausanne Hospitals	Lausanne	Vaud

Sponsors (13)

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

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of CKD-aP	Evaluation of the presence of CKD-aP. This outcome prevalence will be reported in %.	June 27, 2022- October 31, 2023
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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