Clinical trial NCT05415969: CKD-aP Among Adults on Dialysis in Switzerland
Official title: Uremic Pruritus Among Adults on Dialysis in the French Speaking Part of Switzerland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Dialysis
Chronic Kidney Diseases Associated Pruritus
Keywords: Chronic Kidney Disease; Dialysis; Pruritus
Lead sponsor: University of Applied Sciences of Western Switzerland
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
name: Hôpital Fribourgeois
name: University Hospital, Geneva
name: Valais Hospital
name: eHnv Hospital
name: Rennaz Hospital
name: Intercantonal Hospital of Broye
name: GHOL Nyon Hospital
name: Dialyse Riviera
name: Cecil Clinic Hirslanden Private Hospital Group
name: Vifor Pharma
name: Réseau Hospitalier Neuchâtelois
First posted: 2022-06-13
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of CKD-aP
timeFrame: June 27, 2022- October 31, 2023
measure: Severity of CKD-aP using the Visual Analog Scale
timeFrame: June 27, 2022- October 31, 2023
measure: Severity of CKD-aP using the Verbal Rating Scale
timeFrame: June 27, 2022- October 31, 2023
Secondary outcomes:
measure: Sodium level (mmol/l) in sweat
timeFrame: June 27, 2022- October 31, 2023
measure: Chloride level (mmol/l) in sweat
timeFrame: June 27, 2022- October 31, 2023
measure: Potassium level (mmol/l) in sweat
timeFrame: June 27, 2022- October 31, 2023
measure: Calcium level (mg/l) in sweat
timeFrame: June 27, 2022- October 31, 2023
measure: Phosphorus level (mg/ml) in sweat
timeFrame: June 27, 2022- October 31, 2023
measure: Urea level (mmol/l) in sweat
timeFrame: June 27, 2022- October 31, 2023
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University of Lausanne Hospitals
state: Vaud
Study officials:
References: