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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Effect of Isonatremic (vs Conventional) Dialysis Treatment on the Control of Interdialytic Weight Gain in Chronic Kidney Disease Patients on Dialysis (Stage 5D)

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Procedure: Conventional dialysis treatment
* Procedure: Isonatremic dialysis treatment


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 Exclusion criteria: Patient with plasma sodium concentration below 130 or above 140 mmol/ Pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients will be receiving conventional dialysis<br>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<br>* Conventional dialysis treatment<br>Procedure: Isonatremic dialysis treatment<br>* Isonatremic dialysis treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perdialytic tolerance in terms of adverse events occurring | 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. | 1, 2, 3 and 4 months after inclusion | 
| Body composition | Body composition monthly 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 | 
| Rate of Tolerance | Rate of Tolerance 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease patient on dialysis (stage 5D), Extracorporeal purification, Isonatremic dialysis, Sodium