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

Completed

• Conditions: Aortic Surgery; Postoperative Acute Kidney Injury
• Interventions: Procedure: elective or emergency aortic surgery (including ascending, arch, descending thoracic aorta)

• Registration Number: NCT01844219
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

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%).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-28
• Study First Submitted QC: 2013-04-30
• Study First Posted: 2013-05-01
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-24
• Last Update Posted: 2013-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who underwent aortic surgery	elective or emergency aortic surgery (including ascending, arch, descending thoracic aorta)	Patients who underwent aortic surgery in Samsung Medical Center during the period between 2004 and 2010

Primary Outcome Measures

Name	Time	Method
presence of acute kidney injury	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)

Secondary Outcome Measures

Name	Time	Method
Gray zone range of each risk scoring model	within 48 hours	Thresholds with as a sensitivity of \< 90% and a specificity of \< 90%.
Number of patients in the gray zone	within 48 hours after aortic surgery	Number of patients in the gray zone in each risk scoring model

Trial Locations

Locations (1)

Samsung Medical Center, Sungkyunkwan University, School of Medicine; 🇰🇷 Seoul, Korea, Republic of