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

Acute Kidney Injury Clinical Trial

— EQUODIA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03963960
• Other study ID #: CHD039-19
• Status: Terminated
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: April 30, 2022
• Est. primary completion date: April 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Failure, Chronic
• Renal Insufficiency
• Wounds and Injuries

Intervention

Device:
• Hemodialysis with low dialysate flow
Hemodialysis with low dialysate flow
• Conventional triweekly high-flow hemodialysis
Conventional triweekly high-flow hemodialysis

Locations

Country	Name	City	State
France	Centre Hospitalier Départemental Vendée	La Roche-sur-Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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