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NCT Number: NCT06014801

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sendai Medical Center, Sendai, Miyagi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • 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

Exclusion criteria

Patient who meets any of the following exclusion criteria will be excluded.

  • 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.

Treatment and study plan

Dialysate fluid, Filtration replacement fluid

Drug

Dose of continuous hemodialysis and/or hemofiltration

Primary outcomes

  1. Composite of death and duration of kidney replacement therapy at 28 days

    Time frame: 28 days or hospital discharge whichever comes first

    Composite endpoint of death and duration of kidney replacement therapy at 28 days

Secondary outcomes

  1. ICU mortality

    Time frame: 90 days or hospital discharge whichever comes first

  2. Hospital mortality

    Time frame: 90 days or hospital discharge whichever comes first

  3. Dialysis dependence at hospital discharge

    Time frame: 90 days or hospital discharge whichever comes first

  4. 28-day vasopressor-free days

    Time frame: 28 days or hospital discharge whichever comes first

  5. 28-day ventilator-free days

    Time frame: 28 days or hospital discharge whichever comes first

  6. Serum creatinine level at the end of kidney replacement therapy

    Time frame: 90 days or hospital discharge whichever comes first

    Serum creatinine level on the day of final kidney replacement therapy and the day before

  7. 24-hour urine output at the end of kidney replacement therapy

    Time frame: 90 days or hospital discharge whichever comes first

    24-hour urine output on the day of final kidney replacement therapy and the day before

Other outcomes

  1. Hypokalemia

    Time frame: up to 7 days of continuous kidney replacement therapy

  2. Hypophosphatemia

    Time frame: up to 7 days of continuous kidney replacement therapy

  3. Sodium bicarbonate solutions that administered

    Time frame: up to 7 days of continuous kidney replacement therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Tomoko Fujii, MD,PhD

CONTACT

[email protected]

+81 3 3433 1111

Sponsors and collaborators

Lead sponsor

Jikei University School of Medicine

Other

Collaborators

  • Jichi Medical University
  • Keio University
  • Osaka Medical and Pharmaceutical University Hospital
  • Sendai Medical Center
  • Tsuchiura Kyodo General Hospital
  • University of Fukui
  • Wakayama Medical University

Registry information

Official study title

Low-Intensity Versus Medium-Intensity Continuous Kidney Replacement Therapy for Critically Ill Patients (LIMIT): a Multicenter Randomized Clinical Trial

Acronym: LIMIT

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 28, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.