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

NCT01401218 | Completed

• 1 other identifier: 2011-06-077
• Study Type: observational
• Target: 799
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Aortic Surgery

Keywords

thoracic aortic surgery; acute kidney injury

Outcome Measures

Primary Outcomes (1)

• presence of Acute kidney injury

  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)

  1 time, within 48 hours of aortic surgery

Study Arms (1)

thoracic aortic surgery group

patients who underwent thoracic aortic surgery

Other: Electronic Medical Record (EMR) Review

Interventions

Electronic Medical Record (EMR) Review OTHER

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,

Also known as: Electronic Medical Record (EMR)

thoracic aortic surgery group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who underwent thoracic aortic surgery durung 1994 to 2010 period

You may qualify if:

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

You may not qualify if:

• patients who had previous renal failure before aortic surgery

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Electronic Health Records

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sangmin M. Lee, M.D.,Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 25, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 25, 2013

Record last verified: 2013-12

Locations

KR (1)