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Low-intensity Versus Medium-intensity Continuous Kidney Replacement Therapy for Critically Ill Patients (LIMIT)

Primary Purpose

Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dialysate fluid, Filtration replacement fluid
Sponsored by
Jikei University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient who meets all of the following criteria and who has given informed consent. Adults (18 years of age or older, regardless of the time since ICU admission) currently admitted to an intensive care unit*. *Includes high care units, where continuous monitoring is conducted and intensive care physicians are in charge of medical care. A diagnosis of acute kidney injury is made according to the Kidney Disease: Improving Global Outcomes (KDIGO) international diagnostic criteria (one of the following is met) Serum creatinine increased by more than 0.3 mg/dL within 48 hours Serum creatinine increased more than 1.5-fold from baseline and the increase is considered to have occurred within 7 days Oliguria (< 0.5 mL/kg/hr) lasting more than 6 hours The treating intensivist believes that continuous kidney replacement therapy is necessary Exclusion Criteria: Patient who meets any of the following exclusion criteria will be excluded. Receiving chronic dialysis or scheduled for initiation of chronic dialysis Undergoing any kidney replacement therapy or blood purification therapy within 48 hours When kidney replacement therapy using other dialysate or replacement fluids, such as citrate dialysis, is preferred due to coexisting bleeding disorders or allergy to acetate Concomitant blood purification therapy other than hemofiltration/dialysis, such as plasma exchange The patient is in a very critical condition and the treating physician believes that survival for more than 24 hours is unlikely Previous participation in the study After receiving a full explanation of the study and with full understanding, a patient do not consent to participate in the study of their own (or their substitute decision maker's) will. The principal investigator (or an investigator) thinks it to be inappropriate to participate in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Low intensity

    Medium intensity

    Arm Description

    Effluent rate of 12 mL/kg/hr

    Effluent rate of 25 mL/kg/hr

    Outcomes

    Primary Outcome Measures

    28-day kidney replacement therapy free days
    Composite endpoint of death and duration of kidney replacement therapy at 28 days

    Secondary Outcome Measures

    ICU mortality
    Hospital mortality
    Dialysis dependence at hospital discharge
    28-day vasopressor-free days
    28-day ventilator-free days
    Serum creatinine level at the end of kidney replacement therapy
    Serum creatinine level on the day of final kidney replacement therapy and the day before
    24-hour urine output at the end of kidney replacement therapy
    24-hour urine output on the day of final kidney replacement therapy and the day before

    Full Information

    First Posted
    August 16, 2023
    Last Updated
    August 21, 2023
    Sponsor
    Jikei University School of Medicine
    Collaborators
    University of Fukui, Tsuchiura Kyodo General Hospital, Keio University, Wakayama Medical University, Jichi Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06014801
    Brief Title
    Low-intensity Versus Medium-intensity Continuous Kidney Replacement Therapy for Critically Ill Patients
    Acronym
    LIMIT
    Official Title
    Low-Intensity Versus Medium-Intensity Continuous Kidney Replacement Therapy for Critically Ill Patients (LIMIT): A Multicenter Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Jikei University School of Medicine
    Collaborators
    University of Fukui, Tsuchiura Kyodo General Hospital, Keio University, Wakayama Medical University, Jichi Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This clinical trial aims to investigate whether the low treatment intensity (12 mL/kg/hr, low-dose hemodialysis/filtration) or the medium treatment intensity (25 mL/kg/hr, standard-dose hemodialysis/filtration) is more effective and safer for continuous renal replacement therapy in critically ill patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Low intensity
    Arm Type
    Experimental
    Arm Description
    Effluent rate of 12 mL/kg/hr
    Arm Title
    Medium intensity
    Arm Type
    Active Comparator
    Arm Description
    Effluent rate of 25 mL/kg/hr
    Intervention Type
    Drug
    Intervention Name(s)
    Dialysate fluid, Filtration replacement fluid
    Intervention Description
    Dose of continuous hemodialysis and/or hemofiltration
    Primary Outcome Measure Information:
    Title
    28-day kidney replacement therapy free days
    Description
    Composite endpoint of death and duration of kidney replacement therapy at 28 days
    Time Frame
    28 days or hospital discharge whichever comes first
    Secondary Outcome Measure Information:
    Title
    ICU mortality
    Time Frame
    90 days or hospital discharge whichever comes first
    Title
    Hospital mortality
    Time Frame
    90 days or hospital discharge whichever comes first
    Title
    Dialysis dependence at hospital discharge
    Time Frame
    90 days or hospital discharge whichever comes first
    Title
    28-day vasopressor-free days
    Time Frame
    28 days or hospital discharge whichever comes first
    Title
    28-day ventilator-free days
    Time Frame
    28 days or hospital discharge whichever comes first
    Title
    Serum creatinine level at the end of kidney replacement therapy
    Description
    Serum creatinine level on the day of final kidney replacement therapy and the day before
    Time Frame
    90 days or hospital discharge whichever comes first
    Title
    24-hour urine output at the end of kidney replacement therapy
    Description
    24-hour urine output on the day of final kidney replacement therapy and the day before
    Time Frame
    90 days or hospital discharge whichever comes first
    Other Pre-specified Outcome Measures:
    Title
    Hypokalemia
    Time Frame
    up to 7 days of continuous kidney replacement therapy
    Title
    Hypophosphatemia
    Time Frame
    up to 7 days of continuous kidney replacement therapy
    Title
    Sodium bicarbonate solutions that administered
    Time Frame
    up to 7 days of continuous kidney replacement therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient who meets all of the following criteria and who has given informed consent. Adults (18 years of age or older, regardless of the time since ICU admission) currently admitted to an intensive care unit*. *Includes high care units, where continuous monitoring is conducted and intensive care physicians are in charge of medical care. A diagnosis of acute kidney injury is made according to the Kidney Disease: Improving Global Outcomes (KDIGO) international diagnostic criteria (one of the following is met) Serum creatinine increased by more than 0.3 mg/dL within 48 hours Serum creatinine increased more than 1.5-fold from baseline and the increase is considered to have occurred within 7 days Oliguria (< 0.5 mL/kg/hr) lasting more than 6 hours The treating intensivist believes that continuous kidney replacement therapy is necessary Exclusion Criteria: Patient who meets any of the following exclusion criteria will be excluded. Receiving chronic dialysis or scheduled for initiation of chronic dialysis Undergoing any kidney replacement therapy or blood purification therapy within 48 hours When kidney replacement therapy using other dialysate or replacement fluids, such as citrate dialysis, is preferred due to coexisting bleeding disorders or allergy to acetate Concomitant blood purification therapy other than hemofiltration/dialysis, such as plasma exchange The patient is in a very critical condition and the treating physician believes that survival for more than 24 hours is unlikely Previous participation in the study After receiving a full explanation of the study and with full understanding, a patient do not consent to participate in the study of their own (or their substitute decision maker's) will. The principal investigator (or an investigator) thinks it to be inappropriate to participate in this study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tomoko Fujii, MD,PhD
    Phone
    +81 3 3433 1111
    Email
    tofujii-tky@umin.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tomoko Fujii, MD,PhD
    Organizational Affiliation
    Jikei University School of Medicine
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Low-intensity Versus Medium-intensity Continuous Kidney Replacement Therapy for Critically Ill Patients

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