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

Thoracic Aortic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401218
• Other study ID #: 2011-06-077
• Status: Completed
• Phase: N/A
• First received: July 21, 2011
• Last updated: December 24, 2013
• Start date: July 2011
• Est. completion date: September 2012

Study information

• Verified date: December 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 799
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patients who had previous renal failure before aortic surgery

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Thoracic Aortic Surgery

Intervention

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,

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of Acute kidney injury	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)	1 time, within 48 hours of aortic surgery	Yes