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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Acute Renal Failure

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 Design

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Study Type :	Observational
Actual Enrollment :	549 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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

Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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
2. internal validation of the enhanced prediction score [ Time Frame: within 48 hours post-operative ]
   internal Validation: discrimination, calibration, k-fold cross validation and bootstrapping

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 95 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

We included consecutively patients undergoing any type of hepatic surgery for benign as well as malignant diseases between July first, 2002 and October 31, 2007 in a single tertiary care center (Swiss Hepato-Pancreato-Biliary (HPB) Centre, University Hospital of Zurich, Switzerland.

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Switzerland
University Hospital of Zurich, Departmente of Visceral and Transplantation Surgery
Zurich, Switzerland, 8091

Sponsors and Collaborators

University of Zurich

Investigators

Principal Investigator:	Ksenija Slankamenac, med. pract.	University Hospital Zurich, Visceral and Transplantation Surgery

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Slankamenac K, Breitenstein S, Held U, Beck-Schimmer B, Puhan MA, Clavien PA. Development and validation of a prediction score for postoperative acute renal failure following liver resection. Ann Surg. 2009 Nov;250(5):720-8. doi: 10.1097/SLA.0b013e3181bdd840.

Responsible Party:	Ksenija Slankamenac, Md PhD, University of Zurich
ClinicalTrials.gov Identifier:	NCT01318798 History of Changes
Other Study ID Numbers:	StV 33-2009
First Posted:	March 18, 2011
Last Update Posted:	February 10, 2015
Last Verified:	February 2015

Keywords provided by Ksenija Slankamenac, University of Zurich:

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

Additional relevant MeSH terms:

Renal Insufficiency; Acute Kidney Injury; Kidney Diseases	Urologic Diseases; Liver Extracts; Hematinics