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NCT Number: NCT07718568

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique - Hôpitaux de Marseille

Marseille, France

Location contact

Romain Vial, Dr

CONTACT

[email protected]

04913883569 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialysate flow at 400mL/min

Other

Dialysate flow fixed at 400mL/min for one month.

Dialysate flow at 500mL/min

Other

Dialysate flow fixed at 500mL/min for one month.

Primary outcomes

  1. Mesure of Urea Kt/V

    Time frame: 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

Secondary outcomes

  1. Mesure of Beta2-microglobulin clearance

    Time frame: 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

  2. Potassium rate before dialysis

    Time frame: Day 0, Month 1

    Mesure of Potassium rate before dialysis (Blood sample), at Day 0 and Month 1

  3. Phosphorus rate before dialysis

    Time frame: Day 0, Month 1

    Mesure of Phosphorus rate before dialysis (Blood sample), at Day 0 and Month 1

  4. Bicarbonate rate before dialysis

    Time frame: Day 0, Month 1

    Mesure of bicarbonate rate before dialysis (Blood sample), at Day 0 and Month 1

  5. Acid indol acetic dosage rate

    Time frame: 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

  6. Questionnaire The 5-level EQ-5D version (EQ-5D-5L)

    Time frame: 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.

  7. Questionnaire The Kidney Disease Quality of Life 36-item short form survey (KDQoL)

    Time frame: 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.

  8. Indoxyl sulfate dosing rate

    Time frame: 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

  9. Para cresyl sulfate dosage rate

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Romain Vial, Dr

CONTACT

[email protected]

0491383569 ext. + 33

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Collaborators

  • Aix Marseille Université

Registry information

Official study title

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

Acronym: ReDeDia

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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