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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Renal Failure

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with post-operative ARF<br>Patients developing acute renal failure (ARF) following liver surgery ARF was defined according to the RIFLE criteria as an absolute increase in serum-creatinine of more than 0.3 mg/dl above baseline, or an increase of more than 1.5 times the pre-operative baseline value within 48 hours after surgery, or a reduction of urinary output less than 0.5 ml/kg/h for at least 6 hrs. | |
| Patients without post-operative ARF<br>Patients with normal kidney function (without acute renal failure (ARF)) following liver surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of an enhanced prediction score for ARF | 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 | within 48 hours post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision curve analysis | 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 | within 48 hours post-operative | 
| internal validation of the enhanced prediction score | internal Validation: discrimination, calibration, k-fold cross validation and bootstrapping | within 48 hours post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Development, Pre- and intra-operative predictors, Acute renal failure, Liver Surgery, Prediction score, Validation, Clinical consequences, Decision curve analysis, predictors of acute renal failure after liver resection