Prevalence and Severity of Cramps in Chronic Kidney Disease Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cramps, Chronic Kidney Disease(CKD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- Prevalence of cramps in CKD III-V patients. Number of patients having cramps / number of questionned patients [Time frame: Day 0 - visit of inclusion]
Secondary outcome measures (6)
- Measure of Severity of cramps [Time frame: Day 0 - visit of inclusion]
- Frequency of pain intensity [Time frame: Day 0 - visit of inclusion]
- Identification of potential triggering factors [Time frame: Day 0 - visit of inclusion]
- Identification of associated factors (ionic desorders, medical treatment, degree of CKD, …) [Time frame: Day 0 - visit of inclusion]
- Identification of potential improving treatment (medicinal or not) [Time frame: Day 0 - visit of inclusion]
- Impact on Quality Of Life through a questionnaire [Time frame: Day 0 - visit of inclusion]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Transplanted patient with functional graft.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Pitié Salpêtrière Service de néphrologie — Paris
Identifiers
NCT: NCT06737094 · APHP240246 · IDRCB-2024-A00304-43