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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01844219
Enrollment
375
Registered
2013-05-01
Start date
2013-04-30
Completion date
2013-09-30
Last updated
2013-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Surgery, Postoperative Acute Kidney Injury

Keywords

aortic surgery, acute kidney injury, gray zone approach

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%).

Interventions

PROCEDUREelective or emergency aortic surgery (including ascending, arch, descending thoracic aorta)

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
presence of acute kidney injurywithin 48 hour after aortic surgery1. 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

MeasureTime frameDescription
Gray zone range of each risk scoring modelwithin 48 hoursThresholds with as a sensitivity of \< 90% and a specificity of \< 90%.
Number of patients in the gray zonewithin 48 hours after aortic surgeryNumber of patients in the gray zone in each risk scoring model

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026