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

NCT03963960 | Terminated

• 1 other identifier: CHD039-19
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Hemodialysis with low dialysate flow

EXPERIMENTAL

Device: Hemodialysis with low dialysate flow

Conventional triweekly high-flow hemodialysis

ACTIVE COMPARATOR

Device: Conventional triweekly high-flow hemodialysis

Interventions

Hemodialysis with low dialysate flow DEVICE

Hemodialysis with low dialysate flow

Hemodialysis with low dialysate flow

Conventional triweekly high-flow hemodialysis DEVICE

Conventional triweekly high-flow hemodialysis

Conventional triweekly high-flow hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (1)

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, 85925, France

Location

MeSH Terms

Conditions

Acute Kidney Injury; Kidney Failure, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Officials

• Natalia TARGET, PH

  CHD Vendée de la Roche sur Yon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: May 12, 2021
• Primary Completion: April 7, 2022
• Study Completion: April 30, 2022
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

FR (1)