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

Phase 2

Recruiting

• Conditions: Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
• Interventions: Drug: Dialysate fluid, Filtration replacement fluid

• Registration Number: NCT06014801
• Lead Sponsor: Jikei University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-28
• Study Start: 2023-10-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11
• Primary Completion: 2025-12
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 exclusion criteria will be excluded.

1. Receiving chronic dialysis or scheduled for initiation of chronic dialysis
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low intensity	Dialysate fluid, Filtration replacement fluid	12 mL/kg/hr
Medium intensity	Dialysate fluid, Filtration replacement fluid	25 mL/kg/hr

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (9)

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