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Completed

NCT Number: NCT05415969

CKD-aP Among Adults on Dialysis in Switzerland

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Lausanne Hospitals

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CKD-aP

Other

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

Primary outcomes

  1. Prevalence of CKD-aP

    Time frame: June 27, 2022- October 31, 2023

    Evaluation of the presence of CKD-aP. This outcome prevalence will be reported in %.

  2. Severity of CKD-aP using the Visual Analog Scale

    Time frame: June 27, 2022- October 31, 2023

    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.

  3. Severity of CKD-aP using the Verbal Rating Scale

    Time frame: June 27, 2022- October 31, 2023

    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.

Secondary outcomes

  1. Sodium level (mmol/l) in sweat

    Time frame: June 27, 2022- October 31, 2023

    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)

  2. Chloride level (mmol/l) in sweat

    Time frame: June 27, 2022- October 31, 2023

    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)

  3. Potassium level (mmol/l) in sweat

    Time frame: June 27, 2022- October 31, 2023

    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)

  4. Calcium level (mg/l) in sweat

    Time frame: June 27, 2022- October 31, 2023

    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)

  5. Phosphorus level (mg/ml) in sweat

    Time frame: June 27, 2022- October 31, 2023

    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)

  6. Urea level (mmol/l) in sweat

    Time frame: June 27, 2022- October 31, 2023

    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)

Sponsors and collaborators

Lead sponsor

University of Applied Sciences of Western Switzerland

Other

Collaborators

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

Registry information

Official study title

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

Acronym: UP-RAISE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 13, 2022
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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