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

NCT ID: NCT03963960

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-12
• Study Completion Date: 2022-04-30

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.

Conditions

Acute Kidney Injury; Kidney Failure, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hemodialysis with low dialysate flow

Group Type: EXPERIMENTAL

Hemodialysis with low dialysate flow

Intervention Type: DEVICE

Hemodialysis with low dialysate flow

Conventional triweekly high-flow hemodialysis

Group Type: ACTIVE_COMPARATOR

Conventional triweekly high-flow hemodialysis

Intervention Type: DEVICE

Conventional triweekly high-flow hemodialysis

Interventions

Hemodialysis with low dialysate flow

Hemodialysis with low dialysate flow

Intervention Type: DEVICE

Conventional triweekly high-flow hemodialysis

Conventional triweekly high-flow hemodialysis

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalia TARGET, PH

Role: STUDY_DIRECTOR

CHD Vendée de la Roche sur Yon

Locations

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, , France

Countries

France

Other Identifiers

CHD039-19

Identifier Type: -

Identifier Source: org_study_id