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临床试验/NCT03547414
NCT03547414招募中不适用

Does Urinary TIMP2 and IGFBP7 Can Identify High Risk Patients of Progression From Mild and Moderate to Severe Acute Kidney Injury During Septic Shock? HEMOCHECK

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
110
试验地点
1
主要终点
KDIGO classification

研究概览

简要总结

Septic shock is one of the leading causes of death in patients admitted to the intensive care unit (ICU). Acute kidney injury (AKI) occurs in almost 50% of septic patients and is associated with significant mortality. Progression to the last stage (KDIGO stage 3) of AKI is an important step in the disease, as it usually requires initiation of RRT. Renal biomarkers are unable to accurately identify those patients who will progress to severe AKI (KDIGO 3). However, identification of patients at risk of progression to severe AKI could help the clinician to initiate optimal therapy including RRT. A new urine test, the Nephrocheck™ corresponding to the product of the urinary concentrations of 2 markers of renal tubule injury (TIMP2 and IGFBP7) has been validated. The Investigator have already performed two previous studies including septic shock patients (AKICHECK and BIOOCHECK). those previous datas will be reanalysed to examine whether the new urinary biomarkers TIMP2 and IGFBP7 can predict progression within 24 hours and 72 hours from mild and moderate (KDIGO 1 or 2) to severe AKI (KDIGO 3) in patients with septic shock.

-All the datas required will be collected from two previous studies (AKICHECK and BIOCHECK) performed in 3 centers: Amiens medical ICU, Melun medico surgical ICU and Montpellier Medical ICU.

研究设计

研究类型
Observational
观察模型
Case Only
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
否

入选标准

  • •Age 18 or over
  • •Septic shock (according to Bone's criteria) within 4 hours of introduction of catecholamines
  • •AKI, characterized by a KDIGO score ≥ 1
  • •Social security coverage

排除标准

  • •AKI requiring emergency RRT (in the critical care physician's opinion).
  • •Stage 4-5 chronic kidney failure with a GFR below 30 ml/min.
  • •Rapidly progressing renal disorders (glomerulonephritis, HUS, blockage, etc.)
  • •Obstructive AKI
  • •Probable glomerular damage (nephritic syndrome, nephrotic syndrome, chronic glomerulonephritis)
  • •Pregnancy or breastfeeding
  • •Legal guardianship or lack of social security coverage.
  • •Cardiocirculatory arrest
  • •Life expectancy <48 hours.
  • •Child C cirrhosis
  • •Prior occurrence of AKI during the current hospital stay
  • •Transplantation
  • •Subject participating in another study with an exclusion period ongoing at the time of the pre-inclusion

结局指标

主要结局

KDIGO classification

时间窗: 72 hours

predictive value of Nephrocheck™ with regard to the worsening of AKI, defined as severe AKI (KDIGO 3) in 72 hours following inclusion

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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