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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 549

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: March 16, 2011
• First Submitted That Met QC Criteria: March 17, 2011
• First Posted (Estimate): March 18, 2011

Study Record Updates

• Last Update Posted (Estimate): February 10, 2015
• Last Update Submitted That Met QC Criteria: February 9, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Validation; Acute renal failure; Development; Liver Surgery; Pre- and intra-operative predictors; Prediction score; Clinical consequences; Decision curve analysis; predictors of acute renal failure after liver resection
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: StV 33-2009