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

Recruiting
18 years of age
Both
Phase 2/3

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Overview

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

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 intensive care physicians are in charge of medical care.

  2. 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
  3. 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.
          1. Receiving chronic dialysis or scheduled for initiation of chronic dialysis
          2. Undergoing any kidney replacement therapy or blood purification therapy within 48
             hours
          3. 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
          4. Concomitant blood purification therapy other than hemofiltration/dialysis, such as
             plasma exchange
          5. The patient is in a very critical condition and the treating physician believes that
             survival 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, a patient
             do not consent to participate in the study of their own (or their substitute decision
             maker's) will.
          8. The principal investigator (or an investigator) thinks it to be inappropriate to
             participate in this study.

Study details

Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

NCT06014801

Jikei University School of Medicine

26 January 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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