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TerminatedNCT03963960EQUODIAUpdated Jan 25, 2024

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

An interventional study of Hemodialysis with low dialysate flow and Conventional triweekly high-flow hemodialysis in Acute Kidney Injury and Kidney Failure, Chronic, sponsored by Centre Hospitalier Departemental Vendee. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-25.

Sponsored by Centre Hospitalier Departemental Vendee · Not applicable, Interventional, and Treatment

Why this study was terminated
Logistical difficulties in the department due to a lack of paramedical staff and dialysis space.
Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 13 is below the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Centre Hospitalier Departemental Vendee is the lead sponsor of 81 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Hemodialysis with low dialysate flow

    Device: Hemodialysis with low dialysate flow

  • Active comparator
    Conventional triweekly high-flow hemodialysis

    Device: Conventional triweekly high-flow hemodialysis

Interventions

  • DeviceHemodialysis with low dialysate flow

    Hemodialysis with low dialysate flow

  • DeviceConventional triweekly high-flow hemodialysis

    Conventional triweekly high-flow hemodialysis

06

What researchers measure

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

    Time frame: During the first two weeks of dialysis

07

Study locations

1 site
  • Centre Hospitalier Départemental Vendée
    La Roche-sur-Yon, 85925, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03963960
Lead sponsor
Centre Hospitalier Departemental Vendee
Responsible party
Sponsor
First posted
May 28, 2019
Start date
May 12, 2021
Primary completion
Apr 7, 2022
Completion
Apr 30, 2022
Last update
Jan 25, 2024

Study contacts

Natalia TARGET, PH
study director · CHD Vendée de la Roche sur Yon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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