Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis (EQUODIA)
Primary Purpose
Acute Kidney Injury, Kidney Failure, Chronic
Status
Suspended
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hemodialysis with low dialysate flow
Conventional triweekly high-flow hemodialysis
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury
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
Sites / Locations
- Centre Hospitalier Départemental Vendée
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hemodialysis with low dialysate flow
Conventional triweekly high-flow hemodialysis
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03963960
First Posted
May 23, 2019
Last Updated
July 6, 2023
Sponsor
Centre Hospitalier Departemental Vendee
1. Study Identification
Unique Protocol Identification Number
NCT03963960
Brief Title
Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis
Acronym
EQUODIA
Official Title
Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Suspended
Why Stopped
Logistical difficulties in the department due to a lack of paramedical staff and dialysis space.
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Kidney Failure, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hemodialysis with low dialysate flow
Arm Type
Experimental
Arm Title
Conventional triweekly high-flow hemodialysis
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Hemodialysis with low dialysate flow
Intervention Description
Hemodialysis with low dialysate flow
Intervention Type
Device
Intervention Name(s)
Conventional triweekly high-flow hemodialysis
Intervention Description
Conventional triweekly high-flow hemodialysis
Primary Outcome Measure Information:
Title
Number of hypotension episodes
Description
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
Time Frame
During the first two weeks of dialysis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalia TARGET, PH
Organizational Affiliation
CHD Vendée de la Roche sur Yon
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Départemental Vendée
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis
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