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Recruiting Phase 2/3

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

NCT06014801 · tracked via the Priya Life Science Japan tracker
Sponsor
Jikei University School of Medicine
Phase
Phase 2/3
Started
2023-10-30
Last updated
2026-08-05

Condition(s) studied

Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

Investigational drug(s) / intervention(s)

Dialysate fluid, Filtration replacement fluid

Dialysate fluid, Filtration replacement fluid: Dose of continuous hemodialysis and/or hemofiltration

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Composite of death and duration of kidney replacement therapy at 28 days — 28 days or hospital discharge whichever comes first
    Composite endpoint of death and duration of kidney replacement therapy at 28 days

Trial sites (9)

FacilityCityRegionStatus
Sendai Medical Center Sendai Miyagi Recruiting
Osaka Medical and Pharmaceutical University Hospital Takatsuki Osaka Recruiting
University of Fukui Hospital Fukui Japan Recruiting
Tsuchiura Kyodo General Hospital Ibaraki Japan Recruiting
Osaka University Hospital Osaka Japan Not Yet Recruiting
Jichi Medical University Hospital Tochigi Japan Recruiting
Jikei University Hospital Tokyo Japan Recruiting
Keio University Hospital Tokyo Japan Recruiting
Wakayama Medical University Hospital Wakayama Japan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06014801 on ClinicalTrials.gov ↗ ← All trials in Japan