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

Postoperative Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844219
• Other study ID #: 2013-03-059-001
• Status: Completed
• Phase: N/A
• First received: April 28, 2013
• Last updated: December 24, 2013
• Start date: April 2013
• Est. completion date: September 2013

Study information

• Verified date: December 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Aortic Surgery
• Postoperative Acute Kidney Injury

Intervention

Procedure:
• elective or emergency aortic surgery (including ascending, arch, descending thoracic aorta)

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center, Sungkyunkwan University, School of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of acute kidney injury	abrupt (within 48 hours) reduction in kidney function currently defined as; absolute increase in serum creatinine of more than or equal to 0.3 mg/dl (= 26.4 µmol/l),; a percentage increase in serum creatinine of more than or equal to 50% (1.5-fold from baseline), or; 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	Yes
Secondary	Gray zone range of each risk scoring model	Thresholds with as a sensitivity of < 90% and a specificity of < 90%.	within 48 hours	No
Secondary	Number of patients in the gray zone	Number of patients in the gray zone in each risk scoring model	within 48 hours after aortic surgery	No