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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

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01844219
Collaborator
(none)
375
Enrollment
1
Location
5
Duration (Months)
74.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: elective or emergency aortic surgery (including ascending, arch, descending thoracic aorta)

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 Design

Study Type:
Observational
Actual Enrollment :
375 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. presence of acute kidney injury [within 48 hour after aortic surgery]

      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)

    Secondary Outcome Measures

    1. Gray zone range of each risk scoring model [within 48 hours]

      Thresholds with as a sensitivity of < 90% and a specificity of < 90%.

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center, Sungkyunkwan University, School of Medicine Seoul Korea, Republic of 135-710

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jong Hwan Lee, Assistant Professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT01844219
    Other Study ID Numbers:
    • 2013-03-059-001
    First Posted:
    May 1, 2013
    Last Update Posted:
    Dec 25, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by Jong Hwan Lee, Assistant Professor, Samsung Medical Center
    aortic surgery
    acute kidney injury
    gray zone approach
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Wounds and Injuries

    Study Results

    No Results Posted as of Dec 25, 2013