Uremic Pruritus Among Adults on Dialysis in the French Speaking Part of Switzerland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 401
- 试验地点
- 1
- 主要终点
- Prevalence of CKD-aP
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Presence of cognitive impairment or cognitive disorder
结局指标
主要结局
Prevalence of CKD-aP
时间窗: June 27, 2022- October 31, 2023
Evaluation of the presence of CKD-aP. This outcome prevalence will be reported in %.
Severity of CKD-aP using the Visual Analog Scale
时间窗: 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.
Severity of CKD-aP using the Verbal Rating Scale
时间窗: 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.
次要结局
- Calcium level (mg/l) in sweat(June 27, 2022- October 31, 2023)
- Sodium level (mmol/l) in sweat(June 27, 2022- October 31, 2023)
- Urea level (mmol/l) in sweat(June 27, 2022- October 31, 2023)
- Potassium level (mmol/l) in sweat(June 27, 2022- October 31, 2023)
- Phosphorus level (mg/ml) in sweat(June 27, 2022- October 31, 2023)
- Chloride level (mmol/l) in sweat(June 27, 2022- October 31, 2023)
研究者
Nancy Helou
Full Professor UAS
University of Applied Sciences of Western Switzerland