Clinical trial NCT06014801: Low-intensity Versus Medium-intensity Continuous Kidney Replacement Therapy for Critically Ill Patients
Official title: Low-Intensity Versus Medium-Intensity Continuous Kidney Replacement Therapy for Critically Ill Patients (LIMIT): a Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
Lead sponsor: Jikei University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Fukui
name: Tsuchiura Kyodo General Hospital
name: Keio University
name: Wakayama Medical University
name: Jichi Medical University
name: Sendai Medical Center
name: Osaka Medical and Pharmaceutical University Hospital
First posted: 2023-08-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 outcomes:
measure: Composite of death and duration of kidney replacement therapy at 28 days
timeFrame: 28 days or hospital discharge whichever comes first
Secondary outcomes:
measure: ICU mortality
timeFrame: 90 days or hospital discharge whichever comes first
measure: Hospital mortality
timeFrame: 90 days or hospital discharge whichever comes first
measure: Dialysis dependence at hospital discharge
timeFrame: 90 days or hospital discharge whichever comes first
measure: 28-day vasopressor-free days
timeFrame: 28 days or hospital discharge whichever comes first
measure: 28-day ventilator-free days
timeFrame: 28 days or hospital discharge whichever comes first
measure: Serum creatinine level at the end of kidney replacement therapy
timeFrame: 90 days or hospital discharge whichever comes first
measure: 24-hour urine output at the end of kidney replacement therapy
timeFrame: 90 days or hospital discharge whichever comes first
Other outcomes:
measure: Hypokalemia
timeFrame: up to 7 days of continuous kidney replacement therapy
measure: Hypophosphatemia
timeFrame: up to 7 days of continuous kidney replacement therapy
measure: Sodium bicarbonate solutions that administered
timeFrame: up to 7 days of continuous kidney replacement therapy
Locations:
city: Sendai
country: Japan
facility: Sendai Medical Center
state: Miyagi
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
state: Osaka
city: Fukui
country: Japan
facility: University of Fukui Hospital
city: Ibaraki
country: Japan
facility: Tsuchiura Kyodo General Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Tokyo
country: Japan
facility: Jikei University Hospital
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
Study officials:
affiliation: Jikei University School of Medicine
name: Tomoko Fujii, MD,PhD
role: STUDY_CHAIR
References: