CKD-aP Among Adults on Dialysis in Switzerland

NCT05415969 | Completed DMC

• 1 other identifier: 2022-00670
• Study Type: observational
• Target: 401
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Dialysis; Chronic Kidney Diseases Associated Pruritus

Keywords

Chronic Kidney Disease; Dialysis; Pruritus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Sodium level (mmol/l) in sweat

  June 27, 2022- October 31, 2023

• Chloride level (mmol/l) in sweat

  June 27, 2022- October 31, 2023

• Potassium level (mmol/l) in sweat

  June 27, 2022- October 31, 2023

• Calcium level (mg/l) in sweat

  June 27, 2022- October 31, 2023

• Phosphorus level (mg/ml) in sweat

  June 27, 2022- October 31, 2023

Interventions

CKD-aP OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• Presence of cognitive impairment or cognitive disorder

Sponsors & Collaborators

• University of Applied Sciences of Western Switzerland: lead
• University of Lausanne Hospitals: collaborator
• Hôpital Fribourgeois: collaborator
• University Hospital, Geneva: collaborator
• Valais Hospital: collaborator
• eHnv Hospital: collaborator
• Rennaz Hospital: collaborator
• Intercantonal Hospital of Broye: collaborator
• GHOL Nyon Hospital: collaborator
• Dialyse Riviera: collaborator
• Cecil Clinic Hirslanden Private Hospital Group: collaborator
• Vifor Pharma: collaborator
• Réseau Hospitalier Neuchâtelois: collaborator

Study Sites (1)

University of Lausanne Hospitals

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Pruritus

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor UAS

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 13, 2022
• Study Start: September 1, 2022
• Primary Completion: October 9, 2023
• Study Completion: October 9, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CH (1)