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临床试验/NCT01932814
NCT01932814已完成不适用

Retrospective Analysis of Aminoglycoside-associated Acute Renal Injury in Septic Critically Ill Patients

Université Victor Segalen Bordeaux 21 个研究点 分布在 1 个国家目标入组 317 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
317
试验地点
1
主要终点
The incidence of acute renal injury associated with treatment with aminoglycoside in critically ill septic patients

研究概览

简要总结

The purpose of the present study is to determine whether administration of aminoglycosides in septic critically ill patient is a risk factor for acute kidney injury

详细描述

Severe sepsis and septic shock despite recent advances in surviving sepsis campaign remain encumbered by a high mortality rate close to 30%. One cornerstone of the management of these patients remains the early and appropriate antibiotic administration, , which must be also active at the site of infection. Aminoglycosides are often administered in combination with beta lactams in this context . According to the progress in pharmacokinetic management achieved over the past decade, their safety and efficiency tended to increase but many uncertainties remain. The purpose of the present study is to determine whether administration of aminoglycosides in septic critically ill patient is a risk factor for acute kidney injury.

Study design: This is an open retrospective monocentric cohort study including septic critically ill patients from november 2008 to january 2010. To determine the incidence and the specific risk of nephrotoxicity of aminoglycosides, only hospitalized patients without initial acute kidney injury or with rapidly improving kidney function during the three first days will be included.Primary outcome will be the occurrence of acute kidney injury assessed with the RIFLE classification (Risk, Injury, Failure, Loss, and End-stage kidney disease) from day 4 to day 15. Patients receiving aminoglycosides will be compared with a control group, i.e. not receiving them. We estimated hazard ratios (HR) and 95% confidence intervals (CI) with adjusted and propensity score (PS)-matched Cox-proportional hazards models.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 and older
  • Admission to ICU with severe sepsis
  • Hospitalized and without acute kidney injury or with kidney function improved on the third day were included
  • Information provided to the patient or proxy

排除标准

  • Renal replacement therapy before day 3
  • Patients with renal insufficiency J1 (Day 1 creatinine clearance <56.25 ml/mn/1, 73m2) but severely altered between Day 1 and Day 3 (creatinine clearance Day 1/ Day 3> 1 + Day 3 creatinine clearance <37.5 ml/mn/1, 73m2 ) without renal replacement therapy still necessary before J3
  • Prolonged aminoglycosides therapy

结局指标

主要结局

The incidence of acute renal injury associated with treatment with aminoglycoside in critically ill septic patients

时间窗: between day 4 and day 15

次要结局

  • Risk factors of acute kidney injury(between day 1and day 3)

研究者

发起方
Université Victor Segalen Bordeaux 2
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandre Boyer

MD,phD

Université Victor Segalen Bordeaux 2

研究点 (1)

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