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

July 21, 2011
December 24, 2013
July 2011
September 2012   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01401218 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Thoracic Aortic Surgery
Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Thoracic Aortic Surgery

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

patients who underwent thoracic aortic surgery durung 1994 to 2010 period

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)
thoracic aortic surgery group
patients who underwent thoracic aortic surgery
Intervention: Other: Electronic Medical Record (EMR) Review
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
799
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients who underwent thoracic aortic surgery during 1994 to 2010 period

Exclusion Criteria:

  • patients who had previous renal failure before aortic surgery
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01401218
2011-06-077
No
Sangmin M. Lee, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Sangmin M. Lee, M.D.,Ph.D. Samsung Medical Center
Samsung Medical Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP