跳至主要内容
临床试验/NCT02355314
NCT02355314已完成不适用

Doppler-based Renal Resistive Index in Assessing Renal Dysfunction Reversibility in ICU Patients

Centre Hospitalier Universitaire de Saint Etienne5 个研究点 分布在 1 个国家目标入组 367 人开始时间: 2013年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
367
试验地点
5
主要终点
Doppler-based renal resistive index

研究概览

简要总结

Acute kidney injury (AKI) is common in intensive care unit (ICU) patients and remains associated with a dismal prognosis. The diagnosis of AKI relies on functional criteria (oliguria and serum creatinine elevation), which carry several important limitations. Additionally, the investigators lack biomarker that may predict short term renal prognosis.

Doppler-based renal resistive index (RI) measurement is a rapid and noninvasive investigative tool that may hold promise for early AKI detection in ICU patients or in differentiating transient from persistent AKI in selected critically ill patients. Although several studies have suggested adequate performance in predicting short-term reversibility of AKI, most of these studies were performed in limited patient samples. Additionally, a recent study has identified discrepant results regarding its diagnostic performance.

The main objective of this large prospective multicentre study is to assess diagnostic performance of Doppler-based renal resistive index in diagnosing persistent AKI in critically ill patients requiring mechanical ventilation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • •Sinus rhythm
  • •Use of conventional mechanical ventilation

排除标准

  • •Refusal: patient, family or trusted person to participate in the study
  • •Renal artery stenosis known
  • •Severe Chronic Renal Failure (clearance < 30 ml.min-1)

研究组 & 干预措施

ICU patients requiring mechanical ventilation

Experimental

干预措施: Doppler-based renal (Other)

ICU patients requiring mechanical ventilation

Experimental

干预措施: blood sample and urine sample (Biological)

结局指标

主要结局

Doppler-based renal resistive index

时间窗: Day 0

Doppler-based renal resistive index in diagnosing persistent AKI in critically ill patients requiring mechanical ventilation

次要结局

  • usual urinary indices (Fractional excretion of urea, fractional excretion of sodium, ratio U / P urea ratio U / P creatinine)(Day 0)
  • Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2(Day 3)
  • Doppler-based renal resistive index(Day 3)
  • Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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