Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
Conditions
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/filtration) is more effective and safer for continuous renal replacement therapy in critically ill patients.
Interventions
DRUGDialysate fluid, Filtration replacement fluid
Dose of continuous hemodialysis and/or hemofiltration
Sponsors
Jikei University School of Medicine
University of Fukui
Tsuchiura Kyodo General Hospital
Keio University
Wakayama Medical University
Jichi Medical University
Sendai Medical Center
Osaka Medical and Pharmaceutical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of death and duration of kidney replacement therapy at 28 days | 28 days or hospital discharge whichever comes first | Composite endpoint of death and duration of kidney replacement therapy at 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 90 days or hospital discharge whichever comes first | Serum creatinine level on the day of final kidney replacement therapy and the day before |
| 24-hour urine output at the end of kidney replacement therapy | 90 days or hospital discharge whichever comes first | 24-hour urine output on the day of final kidney replacement therapy and the day before |
Countries
Japan
Contacts
CONTACTTomoko Fujii, MD,PhD
STUDY_CHAIRTomoko Fujii, MD,PhD
Jikei University School of Medicine
Outcome results
None listed