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

• Conditions: Chronic Kidney Diseases
• Interventions: Procedure: Conventional dialysis treatment; Procedure: Isonatremic dialysis treatment

• Registration Number: NCT04809493
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-22
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-14
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients will be receiving conventional dialysis	Isonatremic dialysis treatment	Patients will be receiving conventional dialysis treatment followed by isonatremic dialysis treatment during an observational period of 2 months for each treatment
patients will be receiving conventional dialysis	Conventional dialysis treatment	Patients will be receiving conventional dialysis treatment followed by isonatremic dialysis treatment during an observational period of 2 months for each treatment

Primary Outcome Measures

Name	Time	Method
Change of interdialytic weight gain during treatment	1, 2, 3 and 4 months after inclusion	change of interdialytic weight gain during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.

Secondary Outcome Measures

Name	Time	Method
Rate of Tolerance	1, 2, 3 and 4 months after inclusion	Rate of Tolerance during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.
Perdialytic tolerance in terms of adverse events occurring	1, 2, 3 and 4 months after inclusion	Perdialytic tolerance in terms of adverse events occurring during all sessions of the study with isonatremic dialysis vs conventional dialysis for an observational period of 2 months each one.
Body composition	1, 2, 3 and 4 months after inclusion	Body composition monthly during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France