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Идёт набор NCT06014801

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

Фаза II / Фаза III С лечением Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dialysate fluid, Filtration replacement fluid.
Кому может быть актуально
Состояния в реестре: Acute Kidney Injury Requiring Continuous Renal Replacement Therapy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Япония
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Препарат Dialysate fluid, Filtration replacement fluid
    Dose of continuous hemodialysis and/or hemofiltration

Первичные конечные точки

  • Composite of death and duration of kidney replacement therapy at 28 days [Срок оценки: 28 days or hospital discharge whichever comes first]
Вторичные конечные точки (7)
  • ICU mortality [Срок оценки: 90 days or hospital discharge whichever comes first]
  • Hospital mortality [Срок оценки: 90 days or hospital discharge whichever comes first]
  • Dialysis dependence at hospital discharge [Срок оценки: 90 days or hospital discharge whichever comes first]
  • 28-day vasopressor-free days [Срок оценки: 28 days or hospital discharge whichever comes first]
  • 28-day ventilator-free days [Срок оценки: 28 days or hospital discharge whichever comes first]
  • Serum creatinine level at the end of kidney replacement therapy [Срок оценки: 90 days or hospital discharge whichever comes first]
  • 24-hour urine output at the end of kidney replacement therapy [Срок оценки: 90 days or hospital discharge whichever comes first]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Япония · 9 центров
  • Sendai Medical Center — Sendai
  • Osaka Medical and Pharmaceutical University Hospital — Takatsuki
  • University of Fukui Hospital — Fukui
  • Tsuchiura Kyodo General Hospital — Ibaraki
  • Osaka University Hospital — Osaka
  • Jichi Medical University Hospital — Tochigi
  • Jikei University Hospital — Tokyo
  • Keio University Hospital — Tokyo
  • … и ещё 1 центр

Публикации

  • 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 A PMID 40779331

Идентификаторы

NCT: NCT06014801 · JKI23-002 · jRCTs031230292

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗