- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07718568
Impact of Reducing the Dialysate Flow Rate in Chronic Hemodialysis on Dialysis Quality and Environmental Impact on Water Consumption (ReDeDia)
17. juli 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
250
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Romain Vial, Dr
- Telefonnummer: + 33 0491383569
- E-mail: Romain.vial@ap-hm.fr
Studiesteder
-
-
-
Marseille, Frankrig
- assistance publique - hôpitaux de Marseille
-
Kontakt:
- Romain Vial, Dr
- Telefonnummer: +33 04913883569
- E-mail: romain.vial@ap-hm.fr
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. januar 2027
Primær færdiggørelse (Anslået)
1. april 2029
Studieafslutning (Anslået)
1. oktober 2029
Datoer for studieregistrering
Først indsendt
7. juli 2026
Først indsendt, der opfyldte QC-kriterier
17. juli 2026
Først opslået (Faktiske)
22. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Patologiske processer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Kronisk sygdom
- Sygdomsegenskaber
- Nyreinsufficiens
- Patologiske tilstande, tegn og symptomer
- Nyreinsufficiens, kronisk
Andre undersøgelses-id-numre
- RCAPHM25_0445
- 2025-A02924-45 (Anden identifikator: ANSM)
Plan for individuelle deltagerdata (IPD)
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