NCT06014801招募中2 期
Low-Intensity Versus Medium-Intensity Continuous Kidney Replacement Therapy for Critically Ill Patients (LIMIT): A Multicenter Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 11
- 主要终点
- Composite of death and duration of kidney replacement therapy at 28 days
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Medium intensity
Active Comparator
25 mL/kg/hr
干预措施: Dialysate fluid, Filtration replacement fluid (Drug)
Low intensity
Experimental
12 mL/kg/hr
干预措施: Dialysate fluid, Filtration replacement fluid (Drug)
结局指标
主要结局
Composite of death and duration of kidney replacement therapy at 28 days
时间窗: 28 days or hospital discharge whichever comes first
Composite endpoint of death and duration of kidney replacement therapy at 28 days
次要结局
- Serum creatinine level at the end of kidney replacement therapy(90 days or hospital discharge whichever comes first)
- 28-day ventilator-free days(28 days or hospital discharge whichever comes first)
- 28-day vasopressor-free days(28 days or hospital discharge whichever comes first)
- 24-hour urine output at the end of kidney replacement therapy(90 days or hospital discharge whichever comes first)
- 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)
研究者
Tomoko Fujii
Professor
Jikei University School of Medicine
研究点 (11)
Loading locations...
相似试验
招募中
不适用
Effect of Different Intensities of Repeated Low-Level Red-Light Therapy on Choroidal and Retinal Blood Flow Among AdultsChoroidRetinaNCT05747742The Second People's Hospital of Foshan24
招募中
2 期
Evaluation of success of low intensity ultrasound application in the reconstruction of alveolar boneIRCT20181022041411N1Mashhad University of Medical Sciences14
Unknown
不适用
Analgesic Effect of Low Intensity Laser in Patients With Pulpitis of Mandibular Molars.Pulpitis - IrreversibleNCT03553407University of Sao Paulo75
已完成
不适用
Shortness Of Breath in Lung CancerIntrathoracic cancerCancerISRCTN49387307Hull and East Yorkshire Hospitals NHS Trust (HEYHT) (UK)156
已完成
不适用
High-intensity Interval, Low Volume Training in Metabolic SyndromeMetabolic SyndromeInsulin ResistanceNCT03087721Universidad de Antioquia60