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出境医 / 临床实验 / Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis (EQUODIA)

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

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.


Condition or disease Intervention/treatment Phase
Acute Kidney Injury Kidney Failure, Chronic Device: Hemodialysis with low dialysate flow Device: Conventional triweekly high-flow hemodialysis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis
Actual Study Start Date : May 12, 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Hemodialysis with low dialysate flow Device: Hemodialysis with low dialysate flow
Hemodialysis with low dialysate flow
Active Comparator: Conventional triweekly high-flow hemodialysis Device: Conventional triweekly high-flow hemodialysis
Conventional triweekly high-flow hemodialysis
Outcome Measures
Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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
Contacts and Locations

Contacts
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Contact: Chloé MOREAU 0251446572 chloemoreau@chd-vendee.fr

Locations
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France
Centre Hospitalier Départemental Vendée Recruiting
La Roche-sur-Yon, France, 85925
Principal Investigator: Natalia TARGET, PH         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
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Study Director: Natalia TARGET, PH CHD Vendée de la Roche sur Yon
Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE May 28, 2019
Last Update Posted Date May 13, 2021
Actual Study Start Date  ICMJE May 12, 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2021) 		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
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019) 		Episode of hypotension [ Time Frame: During the first two weeks of dialysis ]
Decrease of ≥ 20 mmHg systolic blood pressure or decrease of 10 mmHg diastolic 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis
Official Title  ICMJE Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Kidney Injury
  • Kidney Failure, Chronic
Intervention  ICMJE
  • Device: Hemodialysis with low dialysate flow
    Hemodialysis with low dialysate flow
  • Device: Conventional triweekly high-flow hemodialysis
    Conventional triweekly high-flow hemodialysis
Study Arms  ICMJE
  • Experimental: Hemodialysis with low dialysate flow
    Intervention: Device: Hemodialysis with low dialysate flow
  • Active Comparator: Conventional triweekly high-flow hemodialysis
    Intervention: Device: Conventional triweekly high-flow hemodialysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chloé MOREAU 0251446572 chloemoreau@chd-vendee.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03963960
Other Study ID Numbers  ICMJE CHD039-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Departemental Vendee
Study Sponsor  ICMJE Centre Hospitalier Departemental Vendee
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Natalia TARGET, PH CHD Vendée de la Roche sur Yon
PRS Account Centre Hospitalier Departemental Vendee
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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