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Search / Trial NCT06014801

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

Launched by JIKEI UNIVERSITY SCHOOL OF MEDICINE · Aug 21, 2023

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two different levels of treatment for patients with acute kidney injury who are critically ill and need continuous kidney replacement therapy. The researchers want to find out if a lower treatment intensity (12 mL/kg/hr) is just as effective and safe as a medium treatment intensity (25 mL/kg/hr) when helping these patients.

To be eligible for the trial, participants must be adults aged 18 or older, currently in an intensive care unit, and diagnosed with acute kidney injury based on specific medical criteria, such as a significant increase in kidney-related blood tests. Patients who are already on chronic dialysis or have very severe health issues that make survival unlikely are not eligible. Those who join the study will receive either of the two treatment levels and will be monitored closely by healthcare professionals. This trial is important because it aims to improve the way we treat kidney problems in critically ill patients, potentially leading to better outcomes and safer care.

Gender

ALL

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.

About Jikei University School Of Medicine

Jikei University School of Medicine is a prestigious academic institution located in Tokyo, Japan, dedicated to advancing medical education, research, and clinical practice. With a strong emphasis on innovative healthcare solutions, the university actively sponsors clinical trials aimed at enhancing patient outcomes and contributing to the global medical community. Its multidisciplinary approach fosters collaboration among researchers, clinicians, and students, ensuring the development of cutting-edge therapies and the translation of research findings into practical applications. Committed to ethical standards and rigorous scientific methods, Jikei University School of Medicine plays a vital role in shaping the future of healthcare through its extensive clinical research initiatives.

Locations

Sendai, Miyagi, Japan

Tochigi, , Japan

Takatsuki, Osaka, Japan

Fukui, , Japan

Hiroshima, , Japan

Ibaraki, , Japan

Osaka, , Japan

Tochigi, , Japan

Tokyo, , Japan

Tokyo, , Japan

Wakayama, , Japan

Patients applied

0 patients applied

Trial Officials

Tomoko Fujii, MD,PhD

Study Chair

Jikei University School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported