Prevalence and Severity of Cramps in Chronic Kidney Disease Patients

NCT06737094 | Not Yet Recruiting

• 2 other identifiers: APHP240246IDRCB-2024-A00304-43
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Cramps; Chronic Kidney Disease(CKD)

Keywords

Cramps; Chronic Kidney Disease; Pain

Outcome Measures

Primary Outcomes (1)

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

  Day 0 - visit of inclusion

Secondary Outcomes (6)

• 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

Study Arms (1)

Chronic Kidney Disease (CKD) Patients

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Every patient with Chronic Kidney Disease (non dialysis and dialysis patients)

You may qualify if:

• 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.

You may not qualify if:

• Transplanted patient with functional graft.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié Salpêtrière Service de néphrologie

Paris, 75013, France

Location

MeSH Terms

Conditions

Muscle Cramp; Renal Insufficiency, Chronic; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Marie-Alyette Costa de Beauregard, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Alyette Costa de Beauregard, MD

CONTACT

+ 33 1 42 17 72 03; marie.costadebeauregard@aphp.fr

Jean-Jacques Boffa, PU-PH

CONTACT

+33 (0) 1 56 01 60 29; jean-jacques.boffa@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 17, 2024
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)