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临床试验/NCT02955979
NCT02955979终止不适用

Incidence of Acute Renal Failure Associated With Iodinated Contrast Agents in Pediatrics. Study CANOPY. Prospective Multicenter Study

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
Diuresis

研究概览

简要总结

Iodinated contrast media are now frequently used in diagnostic imaging exams, including pediatrics.

In adults, the acute renal failure (ARF) associated with contrast agents (CA-AKI) occur in 3-33% of exposed patients, especially as the patient is fragile, has comorbidities or pre-existing renal aggression .

In children, the prevalence of this little known disease is probably underestimated.

The investigators intend to conduct a prospective epidemiological study, to estimate the impact of the acute renale failure to iodinated contrast agents in pediatrics.

详细描述

Patients will be included those of pediatric emergencies, Hospitalization Unit of Short Duration pediatric, pediatric intensive care and pediatric resuscitation. The acute renale failure will be estimated on the basis of criteria KDIGO (score of kidney disease) group in 2012 to 48 hours a computed tomography (CT) scan with injection of contrast media, based on a change in creatinine clearance of the estimated according to the formula Schwartz revised in 2009 and / or diuresis.

Patient characteristics will be identified in order to establish risk factors.

研究设计

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

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients under 16 years admitted to a participating service
  • Patient receiving an injected CT scan

排除标准

  • Prior Inclusion in the study during an earlier review.
  • Opposition of parents.
  • Chronic renal failure or end-stage requiring renal replacement in the long term.

结局指标

主要结局

Diuresis

时间窗: change from baseline diuresis at 7 days

data gathered in the medical file

Creatinine

时间窗: change from baseline creatinine at 7 days

data gathered in the medical file

次要结局

  • Renal replacement(at 7 days)
  • Death(at 7 days)
  • Readmission(at 7 days)
  • Hospitalization in intensive care(at 7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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