Skip to main content
OpenTrials
Completed

NCT Number: NCT01844219

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aortic Surgery Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Postoperative Acute Kidney Injury Renal Insufficiency Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center, Sungkyunkwan University, School of Medicine

Seoul, 135-710, South Korea

About this study

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%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Other names: graft interposition of thoracic aorta

Primary outcomes

  1. presence of acute kidney injury

    Time frame: 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 outcomes

  1. 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%.

  2. 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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 1, 2013
Registry last updated
Dec 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.