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

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04809493
Acronym
DISON-IRC
Enrollment
120
Registered
2021-03-22
Start date
2021-03-01
Completion date
2022-12-31
Last updated
2022-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Keywords

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

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.

Interventions

PROCEDUREConventional dialysis treatment

Conventional dialysis treatment

PROCEDUREIsonatremic dialysis treatment

Isonatremic dialysis treatment

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of interdialytic weight gain during treatment1, 2, 3 and 4 months after inclusionchange of interdialytic weight gain during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.

Secondary

MeasureTime frameDescription
Perdialytic tolerance in terms of adverse events occurring1, 2, 3 and 4 months after inclusionPerdialytic 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 composition1, 2, 3 and 4 months after inclusionBody composition monthly during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.
Rate of Tolerance1, 2, 3 and 4 months after inclusionRate of Tolerance during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.

Countries

France

Contacts

Primary ContactJean-Paul CRISTOL, Prof
jp-cristol@chu-montpellier.fr+33(0)4 67 33 83 15

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026