Ionized Magnesium Balance During Hemodialysis Session

NCT05337436 | Unknown

• 1 other identifier: RECHMPL22_0004
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the balance of total and ionized magnesium according to different types of dialysate used in clinical practice (acetate + Mg 0.50 or 0.75 mM vs citrate + Mg 0.50 ou 0.75 mM)

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Disease patient on dialysis (stage 5D); Extracorporeal purification; Ionized magnesium

Outcome Measures

Primary Outcomes (1)

• Comparison of ionized magnesium levels before and after dialysis session

  Comparison of ionized magnesium levels before and after dialysis session

  day 1

Secondary Outcomes (7)

• Comparison of total magnesium levels before and after dialysis session

  day 1

• Comparison of ionized calcium levels before and after dialysis session

  day 1

• Comparison of total calcium levels before and after dialysis session

  day 1

• Per-dialytic balance of ionized magnesium according to predialysis level

  day 1

• Per-dialytic balance of total magnesium according to predialysis level

  day 1

Study Arms (1)

All patients receive conventional dialysis treatment at enrollment

All patients receive conventional dialysis treatment at enrollment

Biological: Lymphatic drainage; Biological: Total and ionized magnesium; Biological: Total and ionized calcium

Interventions

Lymphatic drainage BIOLOGICAL

Biological determination in plasma:

Also known as: Biological determination in plasma:

All patients receive conventional dialysis treatment at enrollment

Total and ionized magnesium BIOLOGICAL

Total and ionized magnesium

All patients receive conventional dialysis treatment at enrollment

Total and ionized calcium BIOLOGICAL

Total and ionized calcium

All patients receive conventional dialysis treatment at enrollment

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

Patients issued from dialysis units (non profit dialysis centers)

You may qualify if:

• Chronic Kidney Disease patient on dialysis (stage 5D) for more than 1 month
• Anuric patient

You may not qualify if:

• Patient protected by law
• Patient under guardianship ou curatorship
• Patient deprived of liberty

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34290, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Study Officials

• Jean-Paul CRISTOL, Prof

  CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE

  STUDY DIRECTOR

Central Study Contacts

Jean-Paul CRISTOL, Prof

CONTACT

+33(0)4 67 33 83 15; jp-cristol@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: April 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: December 10, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

FR (1)