Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Thoracic Aortic Surgery
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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 |
- 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
- 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)
| Estimated Enrollment: | 800 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated 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 |
patients who underwent thoracic aortic surgery durung 1994 to 2010 period
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| Contact: Sangmin M. Lee, M.D.,Ph.D. | 82-2-3410-0362 | sangminm.lee@samsung.com |
| Contact: Won Ho Kim, M.D. | 82-2-3410-1994 | bullet57@naver.com |
| Korea, Republic of | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Contact: Sangmin M. Lee, M.D.,Ph.D. 82-2-3410-0362 sangminm.lee@samsung.com | |
| Contact: Won Ho Kim, M.D. 82-2-3410-1994 bullet57@naver.com | |
| Sub-Investigator: Sangmin M. Lee, M.D.,Ph.D. | |
| 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: | February 15, 2012 |
| 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 Renal Insufficiency Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013