Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Thoracic Aortic Surgery

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01401218
Collaborator
(none)
799
1
14.1
56.8

Study Details

Study Description

Brief Summary

Postoperative acute kidney injury (AKI) is still one of the serious complications of thoracic aortic surgery, with incidence of 8 to 50 percent. Postoperative AKI significantly increases the morbidity and mortality of patients undergoing thoracic aortic surgery. Previous studies for AKI after DHCA reported confounding results due to different criteria of AKI. Therefore, the investigators tried to evaluate the incidence and risk factors of AKI after thoracic aortic surgery according to the diagnostic criteria and staging system of AKI reported from acute kidney injury network. The investigators also tried to develop a risk model with scoring system of AKI and evaluate the performance of the risk model.

Condition or Disease Intervention/Treatment Phase
  • Other: Electronic Medical Record (EMR) Review

Detailed Description

Significant improvement of morbidity and mortality has been achieved during last three decades since developing deep hypothermic circulatory arrest (DHCA). However,postoperative acute kidney injury (AKI) is still one of the serious complications of thoracic aortic surgery, with incidence of 8 to 50 percent. Postoperative AKI significantly increases the morbidity and mortality of patients undergoing thoracic aortic surgery. Previous studies for AKI after DHCA reported confounding results due to different criteria of AKI. Therefore, the investigators tried to evaluate the incidence and risk factors of AKI after thoracic aortic surgery according to the diagnostic criteria and staging system of AKI reported from acute kidney injury network (2007). The investigators also tried to develop a risk model with scoring system of AKI and evaluate the performance of the risk model.

Study Design

Study Type:
Observational
Actual Enrollment :
799 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Thoracic Aortic Surgery
Study Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
thoracic aortic surgery group

patients who underwent thoracic aortic surgery

Other: Electronic Medical Record (EMR) Review
measurements of potential risk factors of acute kidney injury through the patients' previous medical record review. potential risk factors include previous history of hypertension, diabetes, cerebrovascular events, peripheral arterial disease, chronic obstructive pulmonary disease, recent myocardial infarction, coronary artery disease; preoperative glomerular filtration rate, preoperative creatinine level, preoperative cardiac ejection fraction reported on echocardiography, use of preoperative inotropics, use of deep hypothermic cardiac arrest, intraoperative colloid use, intraoperative blood product transfusion, total time of cardiopulmonary bypass,
Other Names:
  • Electronic Medical Record (EMR)
  • Outcome Measures

    Primary Outcome Measures

    1. presence of Acute kidney injury [1 time, within 48 hours of aortic surgery]

      diagnosis of AKI if the record of patient meet one of the below criteria 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients who underwent thoracic aortic surgery during 1994 to 2010 period
    Exclusion Criteria:
    • patients who had previous renal failure before aortic surgery

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    • Principal Investigator: Sangmin M. Lee, M.D.,Ph.D., Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sangmin M. Lee, Professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT01401218
    Other Study ID Numbers:
    • 2011-06-077
    First Posted:
    Jul 25, 2011
    Last Update Posted:
    Dec 25, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by Sangmin M. Lee, Professor, Samsung Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 25, 2013