2023-508071-36-00招募中3 期
RASBU-SEPSIS Study: Effects of rasburicase on renal function during sepsis – a randomized, placebo-controlled, double-blind trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Worsening of renal function defined by at least one of the following: The onset of acute kidney injury (AKI) within 7 days of inclusion. Non-improvement or progression of the stage of AKI according to KDIGO criteria on the 7th day after inclusion
研究概览
简要总结
Determine the effect of Rasburicase on the occurrence and evolution of acute renal failure (ARF) in septic patients with uricemia ≥200 µmol/L.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment Period
- 盲法
- Double (Carer, Analyst, Monitor, Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patients ≥18 years old
- •Diagnosis of sepsis (presumed or known infection and increase in SOFA score ≥ 2), included within 48 hours of diagnosis.
- •Uricémia ≥ 200 µmol/L
- •Rapid diagnostic test strip for G6PD deficiency negative
- •Patient affiliated with a social security scheme
- •Informed consent form signed
- •Woman of childbearing age using effective contraception throughout the treatment and for 1 month after the end of the treatment.
- •Hospitalised in intensive care unit
排除标准
- •Other metabolic disorders known to cause hemolytic anemia
- •Chronic treatment with a urate-lowering agent
- •Enrolled in another
- •Sepsis due to urinary obstruction
- •Surgery involving the kidneys or urinary tract in the last 3 months
- •Life expectancy less than 6 months
- •Pregnant or breastfeeding woman
- •Chronic kidney failure on hemodialysis
- •AKI with need for dialysis treatment estimated within 12 hours
- •Known hypersensitivity to Rasburicase, or to any of the excipients,
- •Pre-existing condition or situation at risk of lysis syndrome
- •Known G6PD deficiency or suggestive family history
结局指标
主要结局
Worsening of renal function defined by at least one of the following: The onset of acute kidney injury (AKI) within 7 days of inclusion. Non-improvement or progression of the stage of AKI according to KDIGO criteria on the 7th day after inclusion
Worsening of renal function defined by at least one of the following: The onset of acute kidney injury (AKI) within 7 days of inclusion. Non-improvement or progression of the stage of AKI according to KDIGO criteria on the 7th day after inclusion
次要结局
- Death rate at D28 and D90
- The maximum SOFA score during the first 7 days
- The evolution of renal aggression markers (N-GAL, Pro-enkephalin, IL-18) in blood and urine at D0, D3, and D7
- The evolution of the leukocyte rate, pro- and anti-inflammatory cytokines (TNFα, IL-1, 6, 8, 10) at D1, D3, and D7
研究者
Benjamin Chousterman
Scientific
Assistance Publique Hopitaux De Paris
研究点 (3)
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