Development and Validation of an Enhanced Prediction Score for Postoperative Acute Renal Failure After Liver Resection

Completed

• 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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-03-16
• Study First Submitted QC: 2011-03-17
• Study First Posted: 2011-03-18
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 549

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

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