跳至主要内容
临床试验/NCT01844219
NCT01844219已完成不适用

Accuracy of Pre-existing Risk Scoring Models for Predicting Acute Kidney Injury in Patients Who Underwent Aortic Surgery Using a Gray Zone Approach

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 375 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
375
试验地点
1
主要终点
presence of acute kidney injury

研究概览

简要总结

Acute kidney injury after cardiac surgery has been reported to increase morbidity and mortality. Several risk scoring models for prediction of aortic kidney injury after cardiac surgery have been developed. However, predictive accuracy of these models is stil unclear. The aim of this study is to evaluate the accuracy of four pre-existing prediction models using a gray zone approach in patients who underwent aortic surgery in our institution.

详细描述

Acute kidney injury after cardiac surgery has been reported to increase morbidity and mortality. Several risk scoring models for prediction of aortic kidney injury after cardiac surgery have been developed. However, predictive accuracy of these models is stil unclear. The aim of this study is to evaluate the accuracy of four pre-existing prediction models (AKICS, Wijeysundera, Mehta, and Thakar model)using a gray zone approach in patients who underwent aortic surgery in our institution. Based on receiver operating characteristic (ROC) curve analysis, we will construct a gray zone using the cut-off values with a sensitivity of < 90%, and a specificity of < 90% (diagnostic tolerance of 10%).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Those who underwent elective or emergency aortic surgery in Samsung Medical Center during between 2004 and 2010.

排除标准

  • missing laboratory data
  • preoperative hemodialysis
  • death during or within 48 hours after surgery

结局指标

主要结局

presence of acute kidney injury

时间窗: within 48 hour after aortic surgery

1. abrupt (within 48 hours) reduction in kidney function currently defined as 2. absolute increase in serum creatinine of more than or equal to 0.3 mg/dl (≥ 26.4 μmol/l), 3. a percentage increase in serum creatinine of more than or equal to 50% (1.5-fold from baseline), or 4. a reduction in urine output (documented oliguria of less than 0.5 ml/kg per hour for more than six hours)

次要结局

  • Gray zone range of each risk scoring model(within 48 hours)
  • Number of patients in the gray zone(within 48 hours after aortic surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jong Hwan Lee

Assistant Professor

Samsung Medical Center

研究点 (1)

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