Status:
RECRUITING
Low-intensity Versus Medium-intensity Continuous Kidney Replacement Therapy for Critically Ill Patients
Lead Sponsor:
Jikei University School of Medicine
Collaborating Sponsors:
University of Fukui
Tsuchiura Kyodo General Hospital
Conditions:
Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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/f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06014801
Start Date
October 30 2023
End Date
September 1 2026
Last Update
October 15 2024
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Sendai Medical Center
Sendai, Miyagi, Japan, 983-8520
2
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, Japan, 569-8686
3
University of Fukui Hospital
Fukui, Japan, 910 1193
4
Tsuchiura Kyodo General Hospital
Ibaraki, Japan, 300 0028