Low-intensity Versus Medium-intensity Continuous Kidney Replacement Therapy for Critically Ill Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dialysate fluid, Filtration replacement fluid.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury Requiring Continuous Renal Replacement Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Low-Intensity Versus Medium-Intensity Continuous Kidney Replacement Therapy for Critically Ill Patients (LIMIT): A Multicenter Randomized Clinical Trial
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.
Interventions
- Drug Dialysate fluid, Filtration replacement fluid
Dose of continuous hemodialysis and/or hemofiltration
Primary outcome measures
- Composite of death and duration of kidney replacement therapy at 28 days [Time frame: 28 days or hospital discharge whichever comes first]
Secondary outcome measures (7)
- ICU mortality [Time frame: 90 days or hospital discharge whichever comes first]
- Hospital mortality [Time frame: 90 days or hospital discharge whichever comes first]
- Dialysis dependence at hospital discharge [Time frame: 90 days or hospital discharge whichever comes first]
- 28-day vasopressor-free days [Time frame: 28 days or hospital discharge whichever comes first]
- 28-day ventilator-free days [Time frame: 28 days or hospital discharge whichever comes first]
- Serum creatinine level at the end of kidney replacement therapy [Time frame: 90 days or hospital discharge whichever comes first]
- 24-hour urine output at the end of kidney replacement therapy [Time frame: 90 days or hospital discharge whichever comes first]
Eligibility criteria
Inclusion Criteria: Patient who meets all of the following criteria and who has given informed consent.
- 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.
- 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
- 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.
- Receiving chronic dialysis or scheduled for initiation of chronic dialysis
- Undergoing any kidney replacement therapy or blood purification therapy within 48 hours
- 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
- Concomitant blood purification therapy other than hemofiltration/dialysis, such as plasma exchange
- The patient is in a very critical condition and the treating physician believes that survival for more than 24 hours is unlikely
- Previous participation in the study
- 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.
- The principal investigator (or an investigator) thinks it to be inappropriate to participate in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 9 centers
- Sendai Medical Center — Sendai
- Osaka Medical and Pharmaceutical University Hospital — Takatsuki
- University of Fukui Hospital — Fukui
- Tsuchiura Kyodo General Hospital — Ibaraki
- Osaka University Hospital — Osaka
- Jichi Medical University Hospital — Tochigi
- Jikei University Hospital — Tokyo
- Keio University Hospital — Tokyo
- … and 1 more center
Publications
- Beaubien-Souligny W, Thompson Bastin M, Teixeira JP, Cerda J, Connor MJ Jr, Dijanic Zeidman A, Garimella PS, Juncos L, Lopez-Ruiz A, Mehta R, Reis T, Rizo-Topete L, Silver SA, Da Silva JR, Speer R, Vijayan A, Wells C, Wille K, Yessayan L, Tolwani A, Neyra JA. Proceedings of the University of Alabama at Birmingham Continuous Renal Replacement Therapy Academy (2023-2024): Managing De-Escalation of A PMID 40779331
Identifiers
NCT: NCT06014801 · JKI23-002 · jRCTs031230292