Low-intensity Versus Medium-intensity Continuous Kidney Replacement Therapy for Critically Ill Patients
NCT ID: NCT06014801
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
400 participants
INTERVENTIONAL
2023-10-30
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low intensity
12 mL/kg/hr
Dialysate fluid, Filtration replacement fluid
Dose of continuous hemodialysis and/or hemofiltration
Medium intensity
25 mL/kg/hr
Dialysate fluid, Filtration replacement fluid
Dose of continuous hemodialysis and/or hemofiltration
Interventions
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Dialysate fluid, Filtration replacement fluid
Dose of continuous hemodialysis and/or hemofiltration
Eligibility Criteria
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Inclusion Criteria
\*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
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.
18 Years
ALL
No
Sponsors
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University of Fukui
OTHER
Tsuchiura Kyodo General Hospital
OTHER
Keio University
OTHER
Wakayama Medical University
OTHER
Jichi Medical University
OTHER
Sendai Medical Center
UNKNOWN
Osaka Medical and Pharmaceutical University Hospital
UNKNOWN
Jikei University School of Medicine
OTHER
Responsible Party
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Tomoko Fujii
Professor
Principal Investigators
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Tomoko Fujii, MD,PhD
Role: STUDY_CHAIR
Jikei University School of Medicine
Locations
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Sendai Medical Center
Sendai, Miyagi, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, Japan
University of Fukui Hospital
Fukui, , Japan
Tsuchiura Kyodo General Hospital
Ibaraki, , Japan
Osaka University Hospital
Osaka, , Japan
Jichi Medical University Hospital
Tochigi, , Japan
Jikei University Hospital
Tokyo, , Japan
Keio University Hospital
Tokyo, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
Countries
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Central Contacts
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Facility Contacts
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Aiko Tanaka, MD, PhD
Role: primary
Akira Endo, MD, PhD
Role: primary
Naoya Iguchi, MD, PhD
Role: primary
Hisashi Imahase, MD
Role: primary
Ryo Yamamoto, MD, PhD
Role: primary
Kyohei Miyamoto, MD, PhD
Role: primary
References
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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 Acute Renal Replacement Therapy and Optimizing Drug Dosing during Renal Replacement Therapy Transitions. Kidney360. 2025 Oct 1;6(10):1798-1809. doi: 10.34067/KID.0000000951. Epub 2025 Aug 8.
Other Identifiers
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jRCTs031230292
Identifier Type: REGISTRY
Identifier Source: secondary_id
JKI23-002
Identifier Type: -
Identifier Source: org_study_id
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