Low-Intensity versus Medium-Intensity continuous kidney replacement Therapy for critically ill patients

JRCT ID: jRCTs031230292

Registered date:15/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Severe acute kidney injury requiring continuous kidney replacement therapy
• Date of first enrollment: 25/11/2023
• Target sample size: 400
• Study type: Interventional
• Intervention(s): Enrolled patients will be randomly allocated to the Low-intensity group or the Medium-intensity group. In the Low-intensity group, a total of 12 mL/kg/hr of replacement and/or dialysis fluid will be administered within the circuit. In the Medium-intensity group, a total of 25 mL/kg/hr of replacement and/or dialysis fluid will be administered within the circuit.

Outcome(s)

• Primary Outcome: Composite of death and duration of kidney replacement therapy at 28 days (28-day KRT-free days)

Secondary Outcome

1. ICU death within 90 days
2. Hospital death within 90 days
3. Dialysis dependence at hospital discharge within 90 days
4. 28-day vasopressor-free days
5. 28-day ventilator-free days
6. Serum creatinine level at the end of kidney replacement therapy (on the final day and the day before)
7. 24-hour urine output at the end of kidney replacement therapy (on the final day and the day before)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

The following inclusion criteria must be met by all participants, and consent must be obtained.
1. Adults (18 years or older) admitted to the intensive care unit*
*High care units are also included if continuous monitoring is conducted, and an intensivist is responsible for the medical care
2.Diagnosed with acute kidney injury based on the KDIGO criteria (meeting any of the following)
- Serum creatinine has increased by 0.3mg/dL or more within 48 hours
- Serum creatinine has increased 1.5 times or more from the baseline, and the increase has occurred within 7 days
- Oliguria (<0.5mL/kg/hr) persists for 6 hours or more
3.Treating physician adjudicates that continuous kidney replacement therapy is necessary

Exclude criteria

Participants will be excluded if they meet any of the following exclusion criteria:
1. Receiving chronic dialysis or planning to initiate chronic dialysis.
2. Having received any form of kidney replacement therapy or blood purification therapy within 48 hours.
3. Kidney replacement therapy using other dialysis fluids or replacement fluids, such as citrate dialysis, is preferred.
4. Other blood purification techniques, such as plasmapheresis, are combined.
5. Imminent death.
6. Previous participation in the study.
7. No consent to participate.
8. A patient who is deemed inappropriate for participation in this study by the investigator.

Related Information

• Primary Sponsor: Fujii Tomoko
• Source(s) of Monetary Support: Japan Society for the Promotion of Science,Terumo Life Science Foundation