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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01318798
Enrollment
549
Registered
2011-03-18
Start date
2010-01-31
Completion date
2012-04-30
Last updated
2015-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure

Keywords

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

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.

Interventions

None listed

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Development of an enhanced prediction score for ARFwithin 48 hours post-operativeDevelopment 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

MeasureTime frameDescription
Decision curve analysiswithin 48 hours post-operativeDescribing 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 scorewithin 48 hours post-operativeinternal Validation: discrimination, calibration, k-fold cross validation and bootstrapping

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026