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RecruitingPhase 2Phase 3NCT06014801

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

Low-Intensity Versus Medium-Intensity Continuous Kidney Replacement Therapy for Critically Ill Patients (LIMIT): a Multicenter Randomized Clinical Trial

Sponsor

Jikei University School of Medicine

Enrollment

400 participants

Start Date

Oct 30, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria8

  • 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.

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Interventions

DRUGDialysate fluid, Filtration replacement fluid

Dose of continuous hemodialysis and/or hemofiltration

Locations(9)

Sendai Medical Center

Sendai, Miyagi, Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, Japan

University of Fukui Hospital

Fukui, Japan

Tsuchiura Kyodo General Hospital

Ibaraki, Japan

Osaka University Hospital

Osaka, Japan

Jichi Medical University Hospital

Tochigi, Japan

Jikei University Hospital

Tokyo, Japan

Keio University Hospital

Tokyo, Japan

Wakayama Medical University Hospital

Wakayama, Japan

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NCT06014801