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

NCT ID: NCT04809493

Last Updated: 2022-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-12-31

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.

Detailed Description

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Conditions

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Chronic Kidney Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Conventional dialysis treatment

Intervention Type PROCEDURE

Conventional dialysis treatment

Isonatremic dialysis treatment

Intervention Type PROCEDURE

Isonatremic dialysis treatment

Interventions

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Conventional dialysis treatment

Conventional dialysis treatment

Intervention Type PROCEDURE

Isonatremic dialysis treatment

Isonatremic dialysis treatment

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Paul CRISTOL, Prof

Role: STUDY_DIRECTOR

UH MONTPELLIER

Locations

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Uhmontpellier

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-Paul CRISTOL, Prof

Role: CONTACT

+33(0)4 67 33 83 15

Facility Contacts

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Jean Paul Cristol, Prof

Role: primary

4 67 33 83 15 ext. 33

Jean-Yves BOSC, MD

Role: backup

430 781 868 ext. 33

Other Identifiers

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RECHMPL20_0659

Identifier Type: -

Identifier Source: org_study_id

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