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临床试验/NCT01318798
NCT01318798已完成不适用

Development and Validation of an Enhanced Prediction Score for Post-operative Acute Renal Failure Following Liver Resection

University of Zurich1 个研究点 分布在 1 个国家目标入组 549 人开始时间: 2010年1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
549
试验地点
1
主要终点
Development of an enhanced prediction score for ARF

研究概览

简要总结

Post-operative acute renal failure is a severe post-operative complication and is associated with high mortality. The enhanced prediction score, including pre-as well as intra-operative predictors accurately predicted ARF following hepatic surgery. This prediction score allows early identification of patients at high risk of ARF and may support decision-making for protective kidney treatment.

详细描述

To enhance and validate an already pre-existing score accurately predicting post-operative acute renal failure (ARF) after hepatic surgery

We will enhance a pre-existing score predicting ARF based on pre-operative as well as intra-operative predictors.

Development process: we will identify the strongest predictors of ARF in a multivariable logistic regression model followed by a stepwise backward logistic regression analysis and bootstrapping.

Validation process: we will perform an internal validation by calibrating the prediction model as well as by k-fold cross validation (c statistics) and bootstrapping. Additionally, we will calculate the discrimination by the area under the curve (AUC).

Decision curve analysis: Furthermore we will perform a decision curve analysis to evaluate the clinical consequences of both prediction scores whether a patient with increased ARF risk would post-operative benefit of a treatment on the ICU.

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 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 18 years
  • scheduled for liver surgery
  • benign as well as malignant diseases

排除标准

  • liver trauma
  • incomplete data sets
  • pre-operative chronic renal failure requiring hemodialysis

结局指标

主要结局

Development of an enhanced prediction score for ARF

时间窗: within 48 hours post-operative

Development of an enhanced but still simple and easy applicable score based on pre- and extended by intra-operative risk factors to predict postoperative ARF in patients scheduled for liver resection

次要结局

  • Decision curve analysis(within 48 hours post-operative)
  • internal validation of the enhanced prediction score(within 48 hours post-operative)

研究者

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

Ksenija Slankamenac

Md PhD

University of Zurich

研究点 (1)

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