Comparing low and medium intensity kidney replacement therapy for critically ill patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sendai Medical Center
  Sendai, Miyagi, Japan Recruiting
• Osaka Medical and Pharmaceutical University Hospital
  Takatsuki, Osaka, Japan Recruiting
• University of Fukui Hospital
  Fukui, Japan Recruiting
• Tsuchiura Kyodo General Hospital
  Ibaraki, Japan Recruiting
• Jichi Medical University Hospital
  Tochigi, Japan Recruiting
• Jikei University Hospital
  Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Tomoko Fujii, MD,PhD
• Email: tofujii-tky@umin.net
• Phone: +81 3 3433 1111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding how patients tolerate fluid removal during kidney support in the ICU

  This observational study tests how well critically ill adults with acute kidney injury tolerate net fluid removal during continuous renal replacement therapy.

  Recruiting at 3 sites Hospital Las Higueras · Salvador and 9 other locations · NCT07643597

• Epidemiology and care for dialysis in ICU patients with severe acute kidney injury in Latin America

  This project will collect and compare data on adults in ICUs across Latin America who need dialysis for severe acute kidney injury to see how they are treated and what outcomes they have.

  Recruiting at 8 sites University of Alabama at Birmingham · Cochabamba and 14 other locations · NCT07262320

• Timing of kidney replacement therapy in tumor lysis syndrome

  This study tests whether starting kidney replacement therapy early versus waiting changes 30-day kidney recovery in adults with tumor lysis syndrome–related acute kidney injury.

  Recruiting at 8 sites University Hospital, Bordeaux · Angers and 9 other locations · NCT06889974

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.