Acute Kidney InjuryEQUODIANCT03963960
Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis
A study testing Hemodialysis with low dialysate flow and Conventional triweekly high-flow hemodialysis in people with Acute Kidney Injury and Kidney Failure, Chronic, run by Centre Hospitalier Departemental Vendee at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Kidney Failure, Chronic
- What is being tested?
- Hemodialysis with low dialysate flow and Conventional triweekly high-flow hemodialysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Hemodialysis with low dialysate flow, Conventional triweekly high-flow hemodialysis
- Medical subject headings
- Acute Kidney Injury, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodialysis with low dialysate flowDevice
Hemodialysis with low dialysate flow
Conventional triweekly high-flow hemodialysisDevice
Conventional triweekly high-flow hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis with low dialysate flow | Experimental | Not described Receives: Device: Hemodialysis with low dialysate flow |
| Conventional triweekly high-flow hemodialysis | Active comparator | Not described Receives: Device: Conventional triweekly high-flow hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the first two weeks of dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start12 May 2021
- Primary completion7 Apr 2022
- Study completion30 Apr 2022
Why it stopped: Logistical difficulties in the department due to a lack of paramedical staff and dialysis space.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalia TARGET, PH, Study director, CHD Vendée de la Roche sur Yon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963960
- Sponsor's protocol ID
- CHD039-19
- Acronym
- EQUODIA
- Status last verified
- Jan 2024
- First submitted
- 23 May 2019
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis
- ClinicalTrials.gov ID
- NCT03963960
- Acronym / sponsor ID
- EQUODIA / CHD039-19
- Conditions
- Acute Kidney Injury, Kidney Failure, Chronic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistical difficulties in the department due to a lack of paramedical staff and dialysis space.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodialysis with low dialysate flowHemodialysis with low dialysate flow | Device | Hemodialysis with low dialysate flow |
| Conventional triweekly high-flow hemodialysisConventional triweekly high-flow hemodialysis | Device | Conventional triweekly high-flow hemodialysis |
Primary outcome
Number of hypotension episodes
Time frame: 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
Results and safety
The study was stopped early (reason given: Logistical difficulties in the department due to a lack of paramedical staff and dialysis space.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia TARGET, PH study director
CHD Vendée de la Roche sur Yon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodialysis with low dialysate flow and Conventional triweekly high-flow hemodialysis in people with Acute Kidney Injury and Kidney Failure, Chronic, run by Centre Hospitalier Departemental Vendee at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Logistical difficulties in the department due to a lack of paramedical staff and dialysis space.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hypotension episodes (time frame: During the first two weeks of dialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.