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

Not Applicable

Terminated

• Conditions: Acute Kidney Injury; Kidney Failure, Chronic
• Interventions: Device: Hemodialysis with low dialysate flow; Device: Conventional triweekly high-flow hemodialysis

• Registration Number: NCT03963960
• Lead Sponsor: Centre Hospitalier Departemental Vendee

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-23
• Study First Posted: 2019-05-28
• Study Start: 2021-05-12
• Primary Completion: 2022-04-07
• Study Completion: 2022-04-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemodialysis with low dialysate flow	Hemodialysis with low dialysate flow	-
Conventional triweekly high-flow hemodialysis	Conventional triweekly high-flow hemodialysis	-

Primary Outcome Measures

Name	Time	Method
Number of hypotension episodes	During the first two weeks of dialysis	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

Trial Locations

Locations (1)

Centre Hospitalier Départemental Vendée; 🇫🇷 La Roche-sur-Yon, France