Accuracy of Pre-existing Risk Scoring Models for Predicting Acute Kidney Injury in Patients Who Underwent Aortic Surgery Using a Gray Zone Approach

December 24, 2013 updated by: Jong Hwan Lee, Samsung Medical Center
Acute kidney injury after cardiac surgery has been reported to increase morbidity and mortality. Several risk scoring models for prediction of aortic kidney injury after cardiac surgery have been developed. However, predictive accuracy of these models is stil unclear. The aim of this study is to evaluate the accuracy of four pre-existing prediction models using a gray zone approach in patients who underwent aortic surgery in our institution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute kidney injury after cardiac surgery has been reported to increase morbidity and mortality. Several risk scoring models for prediction of aortic kidney injury after cardiac surgery have been developed. However, predictive accuracy of these models is stil unclear. The aim of this study is to evaluate the accuracy of four pre-existing prediction models (AKICS, Wijeysundera, Mehta, and Thakar model)using a gray zone approach in patients who underwent aortic surgery in our institution. Based on receiver operating characteristic (ROC) curve analysis, we will construct a gray zone using the cut-off values with a sensitivity of < 90%, and a specificity of < 90% (diagnostic tolerance of 10%).

Study Type

Observational

Enrollment (Actual)

375

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center, Sungkyunkwan University, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Those who underwent elective or emergency aortic surgery in Samsung Medical Center during between 2004 and 2010.

Description

Inclusion Criteria:

  • Those who underwent elective or emergency aortic surgery in Samsung Medical Center during between 2004 and 2010.

Exclusion Criteria:

  • missing laboratory data
  • preoperative hemodialysis
  • death during or within 48 hours after surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who underwent aortic surgery
Patients who underwent aortic surgery in Samsung Medical Center during the period between 2004 and 2010
Procedure: elective or emergency aortic surgery (including ascending, arch, descending thoracic aorta)
Other Names:
  • graft interposition of thoracic aorta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of acute kidney injury
Time Frame: within 48 hour after aortic surgery
  1. abrupt (within 48 hours) reduction in kidney function currently defined as
  2. absolute increase in serum creatinine of more than or equal to 0.3 mg/dl (≥ 26.4 μmol/l),
  3. a percentage increase in serum creatinine of more than or equal to 50% (1.5-fold from baseline), or
  4. a reduction in urine output (documented oliguria of less than 0.5 ml/kg per hour for more than six hours)
within 48 hour after aortic surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gray zone range of each risk scoring model
Time Frame: within 48 hours
Thresholds with as a sensitivity of < 90% and a specificity of < 90%.
within 48 hours
Number of patients in the gray zone
Time Frame: within 48 hours after aortic surgery
Number of patients in the gray zone in each risk scoring model
within 48 hours after aortic surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

April 28, 2013

First Submitted That Met QC Criteria

April 30, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Estimate)

December 25, 2013

Last Update Submitted That Met QC Criteria

December 24, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-03-059-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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