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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
Sponsor:
Information provided by (Responsible Party):
Ksenija Slankamenac, University of Zurich

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 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

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



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



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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

Information from the National Library of Medicine

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


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

Publications of Results:
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    Key Record Dates
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