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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sangmin M. Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01401218
First received: July 21, 2011
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

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 Intervention
Thoracic Aortic Surgery
Other: Electronic Medical Record (EMR) Review

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Thoracic Aortic Surgery

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • presence of Acute kidney injury [ Time Frame: 1 time, within 48 hours of aortic surgery ] [ Designated as safety issue: Yes ]

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

    1. 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)


Enrollment: 799
Study Start Date: July 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Electronic Medical Record (EMR)

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients who underwent thoracic aortic surgery durung 1994 to 2010 period

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01401218

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Sangmin M. Lee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01401218     History of Changes
Other Study ID Numbers: 2011-06-077
Study First Received: July 21, 2011
Last Updated: December 24, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
thoracic aortic surgery
acute kidney injury

Additional relevant MeSH terms:
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 26, 2014