Clinical trial NCT06737094: Prevalence and Severity of Cramps in Chronic Kidney Disease Patients
Official title: Prevalence and Severity of Cramps in Chronic Kidney Disease Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cramps
Chronic Kidney Disease(CKD)
Keywords: Cramps
Chronic Kidney Disease
Pain
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patient with Chronic Kidney Disease (non dialysis and dialysis patients)

Brief summary: 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.

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.

Primary outcomes:
measure: Prevalence of cramps in CKD III-V patients. Number of patients having cramps / number of questionned patients
timeFrame: Day 0 - visit of inclusion
Secondary outcomes:
measure: Measure of Severity of cramps
timeFrame: Day 0 - visit of inclusion
measure: Frequency of pain intensity
timeFrame: Day 0 - visit of inclusion
measure: Identification of potential triggering factors
timeFrame: Day 0 - visit of inclusion
measure: Identification of associated factors (ionic desorders, medical treatment, degree of CKD, …)
timeFrame: Day 0 - visit of inclusion
measure: Identification of potential improving treatment (medicinal or not)
timeFrame: Day 0 - visit of inclusion
measure: Impact on Quality Of Life through a questionnaire
timeFrame: Day 0 - visit of inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière Service de néphrologie
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marie-Alyette Costa de Beauregard, MD
role: PRINCIPAL_INVESTIGATOR
References: