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Prevalence and Severity of Cramps in Chronic Kidney Disease Patients

NCT ID: NCT06737094

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-31

Study Completion Date

2025-07-31

Brief Summary

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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

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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.

Conditions

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Cramps Chronic Kidney Disease(CKD)

Keywords

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Cramps Chronic Kidney Disease Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic Kidney Disease (CKD) Patients

Patients with CKD stade III to V (dialysis and non dialysis)

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie-Alyette Costa de Beauregard, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Pitié Salpêtrière Service de néphrologie

Paris, , France

Site Status

Countries

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France

Central Contacts

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Marie-Alyette Costa de Beauregard, MD

Role: CONTACT

Phone: + 33 1 42 17 72 03

Email: [email protected]

Jean-Jacques Boffa, PU-PH

Role: CONTACT

Phone: +33 (0) 1 56 01 60 29

Email: [email protected]

Facility Contacts

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Marie-Alyette Costa de Beauregard, MD

Role: primary

Other Identifiers

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IDRCB-2024-A00304-43

Identifier Type: OTHER

Identifier Source: secondary_id

APHP240246

Identifier Type: -

Identifier Source: org_study_id