Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis

Study Overview
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Brief Summary
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The objective of the EQUODIA study is to evaluate the hemodynamic stability of hemodialysis with low dialysate flow in patients requiring emergency hemodialysis in the context of acute kidney injury or unscheduled end-stage renal disease, not in intensive care, compared to conventional triweekly high-flow hemodialysis. Short daily hemodialysis has excellent hemodynamic tolerance, which has already been confirmed by clinical experience. This modality, commonly used in the patient's home through new machines allowing a low dialysate flow purification technique, can prove to be an innovative, effective and safe alternative for patients admitted for hemodialysis in an unscheduled situation (acute kidney injury, unscheduled end-stage renal disease not followed). Up to now, no studies have evaluated the use of short daily hemodialysis with low dialysate flow in patients with acute kidney injury or unscheduled end-stage renal disease, requiring the initiation of emergency extra-renal purification.

Official Title
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Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis

Conditions
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Acute Kidney Injury, Kidney Failure, Chronic

Intervention / Treatment
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* Device: Hemodialysis with low dialysate flow
* Device: Conventional triweekly high-flow hemodialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female 18 years of age or older Patient requiring unscheduled hemodialysis for end-stage renal disease or acute kidney injury Patient able to understand the protocol Patient who has agreed to participate in the study and has given express oral consent Patient affiliated to a social security system Exclusion Criteria: Patient with more than one dialysis session Intensive care patient (need for vasoactive amine infusion, non-invasive ventilation, assisted ventilation) Patient participating in interventional clinical research involving a drug/medical device Patient under guardianship, curator, deprived of liberty Pregnant or breastfeeding patient, or with the ability to procreate without effective contraception Patient refusing to participate Patient unable to understand the protocol and/or give express oral consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemodialysis with low dialysate flow<br> | Device: Hemodialysis with low dialysate flow<br>* Hemodialysis with low dialysate flow<br>|
| Active Comparator: Conventional triweekly high-flow hemodialysis<br> | Device: Conventional triweekly high-flow hemodialysis<br>* Conventional triweekly high-flow hemodialysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hypotension episodes | Decrease of ≥ 20 mmHg systolic blood pressure in regard to pre-dialysis value, associated with symptoms such as abdominal pain, yawn, nausea, vomiting, cramps, anxiety, dizziness, malaise and/or loss of consciousness | During the first two weeks of dialysis |