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临床试验/NCT06737094
NCT06737094尚未招募不适用

Prevalence and Severity of Cramps in Chronic Kidney Disease Patients

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
250
试验地点
1
主要终点
Prevalence of cramps in CKD III-V patients. Number of patients having cramps / number of questionned patients

研究概览

简要总结

Cramps are a frequent and severe complication in CKD patients. Their characteristics : triggering factors, associated factors, are not well known. There is no recognized effective treatment. Using a questionnaire, the investigators wish to determine prevalence, severity and associated factors of cramps in our CKD patients. Better knowledge about cramps in CKD patients will allow to better support, and give a practical tool for treatment evaluation.

详细描述

The investigator have elaborated a specific questionnaire for our CKD patient about cramps. This questionnaire concerns only cramps, regardless of the origin. The first question of the questionnaire will allow to evaluate the prevalence of cramps in our population of CKD patients. Every patient will indicate his medical treatment and biological datas. Only patients who will answer " Yes " to the first question will complete the cramp score of gravity questionnaire. This score is composed of 4 items : frequency of crisis, there impact on sleep, there duration and there intesity Patients will also indicate for how long time there have experimented cramps, the muscular zones involved, associated symptoms, triggering factors, and does something can help them for cramps (medicinal or non medicinal).

The third part concerns there treatment and biological datas. Finally there will complete the QOL-SF12 questionnaire.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Voluntary patients with CKD III to V (GFR<60ml/mn/1,72M2), including dialysed patients (hemodialysis or peritoneal dialysis).
  • Non opposed to participate to the research.

排除标准

  • Transplanted patient with functional graft.

结局指标

主要结局

Prevalence of cramps in CKD III-V patients. Number of patients having cramps / number of questionned patients

时间窗: Day 0 - visit of inclusion

次要结局

  • Measure of Severity of cramps(Day 0 - visit of inclusion)
  • Frequency of pain intensity(Day 0 - visit of inclusion)
  • Identification of potential triggering factors(Day 0 - visit of inclusion)
  • Identification of associated factors (ionic desorders, medical treatment, degree of CKD, …)(Day 0 - visit of inclusion)
  • Identification of potential improving treatment (medicinal or not)(Day 0 - visit of inclusion)
  • Impact on Quality Of Life through a questionnaire(Day 0 - visit of inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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