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

Last updated: October 9, 2024
Sponsor: Jikei University School of Medicine
Overall Status: Active - Recruiting

Phase

2/3

Condition

Kidney Failure

Kidney Disease

Renal Failure

Treatment

Dialysate fluid, Filtration replacement fluid

Clinical Study ID

NCT06014801
JKI23-002
jRCTs031230292
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria: Patient who meets all of the following criteria and who has given informed consent.

  1. 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 intensivecare physicians are in charge of medical care.

  1. A diagnosis of acute kidney injury is made according to the Kidney Disease:Improving Global Outcomes (KDIGO) international diagnostic criteria (one of thefollowing 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 isconsidered to have occurred within 7 days

  • Oliguria (< 0.5 mL/kg/hr) lasting more than 6 hours

  1. The treating intensivist believes that continuous kidney replacement therapy isnecessary

Exclusion

Exclusion Criteria: Patient who meets any of the following exclusion criteria will be excluded.

  1. Receiving chronic dialysis or scheduled for initiation of chronic dialysis

  2. Undergoing any kidney replacement therapy or blood purification therapy within 48hours

  3. When kidney replacement therapy using other dialysate or replacement fluids, such ascitrate dialysis, is preferred due to coexisting bleeding disorders or allergy toacetate

  4. Concomitant blood purification therapy other than hemofiltration/dialysis, such asplasma exchange

  5. The patient is in a very critical condition and the treating physician believes thatsurvival for more than 24 hours is unlikely

  6. Previous participation in the study

  7. After receiving a full explanation of the study and with full understanding, apatient do not consent to participate in the study of their own (or their substitutedecision maker's) will.

  8. The principal investigator (or an investigator) thinks it to be inappropriate toparticipate in this study.

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Dialysate fluid, Filtration replacement fluid
Phase: 2/3
Study Start date:
October 30, 2023
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Sendai Medical Center

    Sendai, Miyagi 983-8520
    Japan

    Site Not Available

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, Osaka 569-8686
    Japan

    Site Not Available

  • University of Fukui Hospital

    Fukui, 910 1193
    Japan

    Site Not Available

  • Hiroshima University Hospital

    Hiroshima, 734 0037
    Japan

    Site Not Available

  • Tsuchiura Kyodo General Hospital

    Ibaraki, 300 0028
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Osaka, 565 0871
    Japan

    Site Not Available

  • Jichi Medical University Hospital

    Tochigi, 329 0498
    Japan

    Site Not Available

  • Jikei University Hospital

    Tokyo, 105 8471
    Japan

    Active - Recruiting

  • Keio University Hospital

    Tokyo, 160 0016
    Japan

    Active - Recruiting

  • Wakayama Medical University Hospital

    Wakayama, 641 8509
    Japan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.