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| ID | Type | Description | Link |
|---|---|---|---|
| jRCTs031230292 | Registry Identifier | Japan Registry of Clinical Trials |
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| Name | Class |
|---|---|
| University of Fukui | OTHER |
| Tsuchiura Kyodo General Hospital | OTHER |
| Keio University | OTHER |
| Wakayama Medical University |
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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/filtration) is more effective and safer for continuous renal replacement therapy in critically ill patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low intensity | Experimental | 12 mL/kg/hr |
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| Medium intensity | Active Comparator | 25 mL/kg/hr |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dialysate fluid, Filtration replacement fluid | Drug | Dose of continuous hemodialysis and/or hemofiltration |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite of death and duration of kidney replacement therapy at 28 days | Composite endpoint of death and duration of kidney replacement therapy at 28 days | 28 days or hospital discharge whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| ICU mortality | 90 days or hospital discharge whichever comes first | |
| Hospital mortality | 90 days or hospital discharge whichever comes first | |
| Dialysis dependence at hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Hypokalemia | up to 7 days of continuous kidney replacement therapy | |
| Hypophosphatemia | up to 7 days of continuous kidney replacement therapy | |
| Sodium bicarbonate solutions that administered |
Inclusion Criteria: 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)
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomoko Fujii, MD,PhD | Contact | +81 3 3433 1111 | tofujii-tky@umin.net |
| Name | Affiliation | Role |
|---|---|---|
| Tomoko Fujii, MD,PhD | Jikei University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sendai Medical Center | Not yet recruiting | Sendai | Miyagi | 983-8520 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40779331 | Derived | 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. |
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| OTHER |
| Jichi Medical University | OTHER |
| Sendai Medical Center | UNKNOWN |
| Osaka Medical and Pharmaceutical University Hospital | UNKNOWN |
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| 90 days or hospital discharge whichever comes first |
| 28-day vasopressor-free days | 28 days or hospital discharge whichever comes first |
| 28-day ventilator-free days | 28 days or hospital discharge whichever comes first |
| Serum creatinine level at the end of kidney replacement therapy | Serum creatinine level on the day of final kidney replacement therapy and the day before | 90 days or hospital discharge whichever comes first |
| 24-hour urine output at the end of kidney replacement therapy | 24-hour urine output on the day of final kidney replacement therapy and the day before | 90 days or hospital discharge whichever comes first |
| up to 7 days of continuous kidney replacement therapy |
| Osaka Medical and Pharmaceutical University Hospital | Not yet recruiting | Takatsuki | Osaka | 569-8686 | Japan |
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| University of Fukui Hospital | Not yet recruiting | Fukui | 910 1193 | Japan |
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| Tsuchiura Kyodo General Hospital | Recruiting | Ibaraki | 300 0028 | Japan |
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| Osaka University Hospital | Not yet recruiting | Osaka | 565 0871 | Japan |
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| Jichi Medical University Hospital | Not yet recruiting | Tochigi | 329 0498 | Japan |
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| Jikei University Hospital | Recruiting | Tokyo | 105 8471 | Japan |
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| Keio University Hospital | Recruiting | Tokyo | 160 0016 | Japan |
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| Wakayama Medical University Hospital | Not yet recruiting | Wakayama | 641 8509 | Japan |
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