Prevalence and Severity of Cramps in Chronic Kidney Disease Patients

Not yet recruiting

• Conditions: Cramps; Chronic Kidney Disease(CKD)

• Registration Number: NCT06737094
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-11-28
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Study Start: 2025-01
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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.

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Exclusion Criteria

• Transplanted patient with functional graft.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of cramps in CKD III-V patients. Number of patients having cramps / number of questionned patients	Day 0 - visit of inclusion

Secondary Outcome Measures

Name	Time	Method
Measure of Severity of cramps	Day 0 - visit of inclusion	with a scale
Frequency of pain intensity	Day 0 - visit of inclusion
Identification of potential triggering factors	Day 0 - visit of inclusion	through a questionnaire triggering factors will be identified
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	through a questionnaire which identified potential improving treatment
Impact on Quality Of Life through a questionnaire	Day 0 - visit of inclusion	impact of cramps on their daily life

Trial Locations

Locations (1)

Hôpital Pitié Salpêtrière Service de néphrologie; 🇫🇷 Paris, France