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Clinical Trials/NCT01318798
NCT01318798
Completed
Not Applicable

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

University of Zurich1 site in 1 country549 target enrollmentJanuary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Renal Failure
Sponsor
University of Zurich
Enrollment
549
Locations
1
Primary Endpoint
Development of an enhanced prediction score for ARF
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
April 2012
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ksenija Slankamenac

Md PhD

University of Zurich

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Development of an enhanced prediction score for ARF

Time Frame: 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 Outcomes

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

Study Sites (1)

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