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

Jikei University School of Medicine

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

Treatments: Drug: Dialysate fluid, Filtration replacement fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT06014801

JKI23-002

jRCTs031230292 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Low intensity

Experimental group

Description:

12 mL/kg/hr

Treatment:

Drug: Dialysate fluid, Filtration replacement fluid

Medium intensity

Active Comparator group

Description:

25 mL/kg/hr

Treatment:

Drug: Dialysate fluid, Filtration replacement fluid