Low-intensity Versus Medium-intensity Continuous Kidney Replacement Therapy for Critically Ill Patients

NCT06014801 | Recruiting Phase 2 DMC

• 2 other identifiers: JKI23-002jRCTs031230292
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 9

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.

Conditions

Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

Other Outcomes (3)

• 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

  up to 7 days of continuous kidney replacement therapy

Study Arms (2)

Low intensity

EXPERIMENTAL

12 mL/kg/hr

Drug: Dialysate fluid, Filtration replacement fluid

Medium intensity

ACTIVE COMPARATOR

25 mL/kg/hr

Drug: Dialysate fluid, Filtration replacement fluid

Interventions

Dialysate fluid, Filtration replacement fluid DRUG

Dose of continuous hemodialysis and/or hemofiltration

Low intensity; Medium intensity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jikei University School of Medicine: lead
• University of Fukui: collaborator
• Tsuchiura Kyodo General Hospital: collaborator
• Keio University: collaborator
• Wakayama Medical University: collaborator
• Jichi Medical University: collaborator
• Sendai Medical Center: collaborator
• Osaka Medical and Pharmaceutical University Hospital: collaborator

Study Sites (9)

Sendai Medical Center

Sendai, Miyagi, 983-8520, Japan

NOT YET RECRUITING

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, 569-8686, Japan

NOT YET RECRUITING

University of Fukui Hospital

Fukui, 910 1193, Japan

NOT YET RECRUITING

Tsuchiura Kyodo General Hospital

Ibaraki, 300 0028, Japan

RECRUITING

Osaka University Hospital

Osaka, 565 0871, Japan

NOT YET RECRUITING

Jichi Medical University Hospital

Tochigi, 329 0498, Japan

NOT YET RECRUITING

Jikei University Hospital

Tokyo, 105 8471, Japan

RECRUITING

Keio University Hospital

Tokyo, 160 0016, Japan

RECRUITING

Wakayama Medical University Hospital

Wakayama, 641 8509, Japan

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 40779331 DERIVED

Study Officials

• Tomoko Fujii, MD,PhD

  Jikei University School of Medicine

  STUDY CHAIR

Central Study Contacts

Tomoko Fujii, MD,PhD

CONTACT

+81 3 3433 1111; tofujii-tky@umin.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 28, 2023
• Study Start: October 30, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

JP (9)