Study Evaluating the Effect of Isonatremic Dialysis Treatment in Chronic Kidney Disease Patients on Dialysis

NCT04809493 | Unknown

• 1 other identifier: RECHMPL20_0659
• Study Type: observational
• Target: 120
• 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 effect of treatment with isonatremic dialysis (vs conventional dialysis), during an observational period of 2 months each, on:

• control of interdialytic weight gain
• perdialytic tolerance in terms of adverse events occurring during all of the sessions of the study
• body composition and thirst measured monthly during the 4 months of follow-up.
• tolerance to treatment.

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Disease patient on dialysis (stage 5D); Extracorporeal purification; Isonatremic dialysis; Sodium

Outcome Measures

Primary Outcomes (1)

• Change of interdialytic weight gain during treatment

  change of interdialytic weight gain during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.

  1, 2, 3 and 4 months after inclusion

Secondary Outcomes (3)

• Perdialytic tolerance in terms of adverse events occurring

  1, 2, 3 and 4 months after inclusion

• Body composition

  1, 2, 3 and 4 months after inclusion

• Rate of Tolerance

  1, 2, 3 and 4 months after inclusion

Study Arms (1)

patients will be receiving conventional dialysis

Patients will be receiving conventional dialysis treatment followed by isonatremic dialysis treatment during an observational period of 2 months for each treatment

Procedure: Conventional dialysis treatment; Procedure: Isonatremic dialysis treatment

Interventions

Conventional dialysis treatment PROCEDURE

Conventional dialysis treatment

patients will be receiving conventional dialysis

Isonatremic dialysis treatment PROCEDURE

Isonatremic dialysis treatment

patients will be receiving conventional 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

Patients issued from dialysis units (hospital, clinic, non profit dialysis centers)

You may qualify if:

• Chronic Kidney Disease patient on dialysis (stage 5D)
• With plasma sodium concentration between 130 and 140 mmol/L
• Anuric
• Patient dialysed with dialysis machine allowing isonatremic dialysis treatment

You may not qualify if:

• Patient with plasma sodium concentration below 130 or above 140 mmol/
• Pacemaker

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34290, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

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

Study Officials

• Jean-Paul CRISTOL, Prof

  UH MONTPELLIER

  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: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 22, 2021
• Study Start: March 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

FR (1)