Development and Validation of an Enhanced Prediction Score for Postoperative Acute Renal Failure After Liver Resection
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|ClinicalTrials.gov Identifier: NCT01318798|
Recruitment Status : Completed
First Posted : March 18, 2011
Last Update Posted : February 10, 2015
|Condition or disease|
|Acute Renal Failure|
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 Type :||Observational|
|Actual Enrollment :||549 participants|
|Official Title:||Development and Validation of an Enhanced Prediction Score for Post-operative Acute Renal Failure Following Liver Resection|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Patients with post-operative ARF
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
Patients with normal kidney function (without acute renal failure (ARF)) following liver surgery
- 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
- Decision curve analysis [ Time Frame: 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 [ Time Frame: within 48 hours post-operative ]internal Validation: discrimination, calibration, k-fold cross validation and bootstrapping
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318798
|University Hospital of Zurich, Departmente of Visceral and Transplantation Surgery|
|Zurich, Switzerland, 8091|
|Principal Investigator:||Ksenija Slankamenac, med. pract.||University Hospital Zurich, Visceral and Transplantation Surgery|