Comparing low and medium intensity kidney replacement therapy for critically ill patients
Low-Intensity Versus Medium-Intensity Continuous Kidney Replacement Therapy for Critically Ill Patients (LIMIT): a Multicenter Randomized Clinical Trial
This study tests whether low-intensity or medium-intensity kidney treatment is better for critically ill patients with acute kidney injury in the ICU.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jikei University School of Medicine Academic / other |
| Locations | 9 sites (Sendai, Miyagi and 8 other locations) |
| Trial ID | NCT06014801 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of low-intensity versus medium-intensity continuous renal replacement therapy in critically ill patients with acute kidney injury. Participants will receive either low-dose hemodialysis/filtration at 12 mL/kg/hr or standard-dose at 25 mL/kg/hr. The study aims to determine which treatment intensity leads to better patient outcomes. It includes adults admitted to intensive care units who require this therapy based on specific diagnostic criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are currently admitted to an intensive care unit and diagnosed with acute kidney injury.
Not a fit: Patients who do not require continuous kidney replacement therapy or have contraindications to the treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for critically ill patients with acute kidney injury, enhancing their recovery and safety.
How similar studies have performed: Other studies have explored various intensities of kidney replacement therapy, but this specific comparison of low versus medium intensity is novel.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Sendai, Miyagi and 8 other locations
- Sendai Medical Center — Sendai, Miyagi, Japan (Not_yet_recruiting)
- Osaka Medical and Pharmaceutical University Hospital — Takatsuki, Osaka, Japan (Not_yet_recruiting)
- University of Fukui Hospital — Fukui, Japan (Not_yet_recruiting)
- Tsuchiura Kyodo General Hospital — Ibaraki, Japan (Recruiting)
- Osaka University Hospital — Osaka, Japan (Not_yet_recruiting)
- Jichi Medical University Hospital — Tochigi, Japan (Not_yet_recruiting)
- Jikei University Hospital — Tokyo, Japan (Recruiting)
- Keio University Hospital — Tokyo, Japan (Recruiting)
- Wakayama Medical University Hospital — Wakayama, Japan (Not_yet_recruiting)
Study contacts
- Study coordinator: Tomoko Fujii, MD,PhD
- Email: tofujii-tky@umin.net
- Phone: +81 3 3433 1111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.