- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07718568
Impact of Reducing the Dialysate Flow Rate in Chronic Hemodialysis on Dialysis Quality and Environmental Impact on Water Consumption (ReDeDia)
17. juli 2026 oppdatert av: Assistance Publique Hopitaux De Marseille
Non-inferiority Study on the Efficacy of Hemodialysis With Dialysate Flow Rates of 400 mL/Min Versus 500 mL/Min in a Population of Patients Undergoing Chronic Hemodialysis. Impact of Reducing the Dialysate Flow Rate in Chronic Hemodialysis on Dialysis Quality and Environmental Impact on Water Consumption
In France, 60,000 patients are receiving renal replacement therapy via dialysis in 2022, 90% of whom are on hemodialysis.
This technique is based on the principle of exchange across a membrane between the patient's blood and the dialysate.
The goal is to purify the patient's blood as effectively as possible by removing all solutes that have accumulated due to kidney failure.
The dialysate is produced from municipal water, which is treated through several processes (reverse osmosis, filtration) to produce ultrapure water.
Water consumption at the La Conception Hospital center in Marseille, which conducts 37,000 sessions per year (64 hemodialysis stations), is estimated at 120 m³ of water per day, which is discharged into the sewer system after use.
In France, this would correspond to an estimated total consumption of nearly one million m³ of drinking water per year.
In the context of climate change, which will lead to a reduction in water resources, it is important to rethink all aspects of water consumption.
The investigator's reflection is part of a growing awareness of the environmental impact of dialysis within a working group of the Francophone Society of Nephrology, Dialysis, and Transplantation: "Green Dialysis."
The quality of clearance depends on blood flow and dialysate flow rate (Qd).
The Qd was set at 500 mL/min based on earlier studies that showed this flow rate corresponded to maximum clearance of urea and the main toxic solutes.
These studies were conducted at a time when dialysis membranes were less efficient.
Today, the investigators use membranes with higher exchange efficiency.
Despite this, the investigators have not reevaluated the appropriateness of a Qd of 500 mL/min.
The quality criterion in dialysis is a balanced urea Kt/V measurement >1.2 for a 4-hour session (target set at 1.4 with certain "single-pool" dialysis machine measurement techniques).
At the ivnestigator's center, the average urea Kt/V is 1.55 in "single-pool" mode.
Reducing the Qd could be done without risk to patients, even if it leads to a decrease in urea Kt/V.
A Colombian study with 5 years of follow-up demonstrates patient safety with a Qd of 400 mL/min (vs.
500 mL/min), with no difference in mortality or dialysis efficacy.
The study population was not representative of chronic dialysis patients; 10% regained renal function, and the final analysis included only 25 of the 71 patients enrolled.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
250
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Romain Vial, Dr
- Telefonnummer: + 33 0491383569
- E-post: Romain.vial@ap-hm.fr
Studiesteder
-
-
-
Marseille, Frankrike
- assistance publique - hôpitaux de Marseille
-
Ta kontakt med:
- Romain Vial, Dr
- Telefonnummer: +33 04913883569
- E-post: romain.vial@ap-hm.fr
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Age > 18 years
- No decompensated psychiatric disorder, acute or decompensated somatic condition
- Patients on hemodialysis for more than 3 months
- Dialysis schedule: 3 times per week for 4 hours each session
- Stable vascular access (arteriovenous fistula or tunneled central catheter)
- Blood flow > 300 mL/min
- Anuric (urine output < 500 mL/24 h)
- Dialysis method: hemodialysis or hemodiafiltration
Exclusion Criteria:
- Age < 18 years
- Patient on dialysis for < 3 months
- Unstable vascular access
- Blood flow rate < 300 mL/min
- Urine output > 500 mL/day
- Dialysis technique: hemofiltration
- Severe intercurrent condition (somatic or psychiatric)
- Pregnant or breastfeeding patients.
- Patients who are legally incapacitated, under guardianship, or under conservatorship
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Dialysate flow at 400mL/min
|
Dialysate flow fixed at 400mL/min for one month.
|
|
Aktiv komparator: Dialysate flow at 500mL/min
|
Dialysate flow fixed at 500mL/min for one month.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mesure of Urea Kt/V
Tidsramme: Day 0, Month 1
|
Mesure of Urea clearance by two blood samples, after dialysis minus before dialyse (of urea blood sample), at Day 0 and Month 1
|
Day 0, Month 1
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mesure of Beta2-microglobulin clearance
Tidsramme: Day 0, Month 1
|
Mesure of Beta2-microglobulin clearance by two blood samples, after dialysis minus before dialyse (of urea blood sample), at Day 0 and Month 1
|
Day 0, Month 1
|
|
Potassium rate before dialysis
Tidsramme: Day 0, Month 1
|
Mesure of Potassium rate before dialysis (Blood sample), at Day 0 and Month 1
|
Day 0, Month 1
|
|
Phosphorus rate before dialysis
Tidsramme: Day 0, Month 1
|
Mesure of Phosphorus rate before dialysis (Blood sample), at Day 0 and Month 1
|
Day 0, Month 1
|
|
Bicarbonate rate before dialysis
Tidsramme: Day 0, Month 1
|
Mesure of bicarbonate rate before dialysis (Blood sample), at Day 0 and Month 1
|
Day 0, Month 1
|
|
Acid indol acetic dosage rate
Tidsramme: Day 0, Month 1 - Only for patient in dialysis in Assistance Publique Hopitaux de Marseille
|
Blood sample before dialysis at Day 0 and Month 1
|
Day 0, Month 1 - Only for patient in dialysis in Assistance Publique Hopitaux de Marseille
|
|
Questionnaire The 5-level EQ-5D version (EQ-5D-5L)
Tidsramme: Day 0, Month 1
|
Questionnaries Quality of life EQ-5D-5L for patients, at Day 0 and Month 1. Scale ranging from 0 to 100, higher scores mean a better outcome.
|
Day 0, Month 1
|
|
Questionnaire The Kidney Disease Quality of Life 36-item short form survey (KDQoL)
Tidsramme: Day 0, Month 1
|
Questionnaries Quality of life for patients KDQoL, at Day 0 and Month 1. Scale ranging from 0 to 100, higher scores mean a better outcome.
|
Day 0, Month 1
|
|
Indoxyl sulfate dosing rate
Tidsramme: Day 0, Month 1 - Only for patient in dialysis in Assistance Publique Hopitaux de Marseille
|
Blood sample before dialysis at Day 0 and Month 1
|
Day 0, Month 1 - Only for patient in dialysis in Assistance Publique Hopitaux de Marseille
|
|
Para cresyl sulfate dosage rate
Tidsramme: Day 0, Month 1 - Only for patient in dialysis in Assistance Publique Hopitaux de Marseille
|
Blood sample before dialysis at Day 0 and Month 1
|
Day 0, Month 1 - Only for patient in dialysis in Assistance Publique Hopitaux de Marseille
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. januar 2027
Primær fullføring (Antatt)
1. april 2029
Studiet fullført (Antatt)
1. oktober 2029
Datoer for studieregistrering
Først innsendt
7. juli 2026
Først innsendt som oppfylte QC-kriteriene
17. juli 2026
Først lagt ut (Faktiske)
22. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Patologiske prosesser
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Kronisk sykdom
- Sykdomsattributter
- Nyreinsuffisiens
- Patologiske tilstander, tegn og symptomer
- Nyresvikt, kronisk
Andre studie-ID-numre
- RCAPHM25_0445
- 2025-A02924-45 (Annen identifikator: ANSM)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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