Development and Validation of an Enhanced Prediction Score for Postoperative Acute Renal Failure After Liver Resection
- Conditions
 - Acute Renal Failure
 
- Registration Number
 - NCT01318798
 
- Lead Sponsor
 - University of Zurich
 
- Brief Summary
 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.
- Detailed Description
 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.
Recruitment & Eligibility
- Status
 - COMPLETED
 
- Sex
 - All
 
- Target Recruitment
 - 549
 
- > 18 years
 - scheduled for liver surgery
 - benign as well as malignant diseases
 
- liver trauma
 - incomplete data sets
 - pre-operative chronic renal failure requiring hemodialysis
 
Study & Design
- Study Type
 - OBSERVATIONAL
 
- Study Design
 - Not specified
 
- Primary Outcome Measures
 Name Time Method Development of an enhanced prediction score for ARF 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
- Secondary Outcome Measures
 Name Time Method Decision curve analysis within 48 hours post-operative Describing a decision making model by performing a decision curve analysis for clinical consequences of the enhanced prediction score and comparing it with the pre-operative prediction score
internal validation of the enhanced prediction score within 48 hours post-operative internal Validation: discrimination, calibration, k-fold cross validation and bootstrapping
Trial Locations
- Locations (1)
 University Hospital of Zurich, Departmente of Visceral and Transplantation Surgery
🇨🇭Zurich, Switzerland
University Hospital of Zurich, Departmente of Visceral and Transplantation Surgery🇨🇭Zurich, Switzerland
