CKD-aP Among Adults on Dialysis in Switzerland

NCT ID: NCT05415969

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

401 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-10-09

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.

Detailed Description

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Conditions

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Chronic Kidney Diseases Dialysis Chronic Kidney Diseases Associated Pruritus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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CKD-aP

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

Intervention Type OTHER

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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne Hospitals

OTHER

Sponsor Role collaborator

Hôpital Fribourgeois

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role collaborator

Valais Hospital

UNKNOWN

Sponsor Role collaborator

eHnv Hospital

UNKNOWN

Sponsor Role collaborator

Rennaz Hospital

UNKNOWN

Sponsor Role collaborator

Intercantonal Hospital of Broye

UNKNOWN

Sponsor Role collaborator

GHOL Nyon Hospital

UNKNOWN

Sponsor Role collaborator

Dialyse Riviera

UNKNOWN

Sponsor Role collaborator

Cecil Clinic Hirslanden Private Hospital Group

UNKNOWN

Sponsor Role collaborator

Vifor Pharma

INDUSTRY

Sponsor Role collaborator

Réseau Hospitalier Neuchâtelois

OTHER

Sponsor Role collaborator

University of Applied Sciences of Western Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Nancy Helou

Full Professor UAS

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Lausanne Hospitals

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2022-00670

Identifier Type: -

Identifier Source: org_study_id

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