Incidence and Risk Factors of Acute Kidney Injury After Thoracic Aortic Surgery Due to Dissection

Completed

• Conditions: Dissection of Thoracic Aorta

• Registration Number: NCT02190487
• Lead Sponsor: Yonsei University

Brief Summary

Acute kidney injury (AKI) is one of the most frequently encountered and prognostically significant complications after cardiovascular surgery. However, there is no definitive treatment to intervene after development of AKI, therefore, preventive strategy has been the major issue. By this time, incidence of AKI after cardiovascular surgery has been reported 3-50% based on the studies with various definition of AKI and different patient cohorts. Development of unified definition for AKI in the early 2000s opened a new era in AKI study.

According to the previous studies, aortic surgery, especially thoracic aortic surgery was known to be highly prevalent of AKI, which was considered to be caused by use of total circulatory arrest (TCA), relatively high number of emergency cases, combined malperfusion syndrome before surgery and relatively complicated surgical procedure. However, there has not been many studies of AKI in thoracic aortic surgery because of its low incidence and urgent clinical presentation of aortic pathology, which hinder large randomized controlled study. Moreover, there are conflicting reports of incidence and risk factors of AKI after thoracic aortic surgery, no conclusive result has been made. Therefore, this study was designed to investigate the incidence and risk factors after thoracic aortic surgery only due to dissection.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-07
• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-11
• Last Update Submitted: 2014-07-14
• Study First Posted: 2014-07-15
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• thoracic aortic surgery due to dissection

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Exclusion Criteria

• chronic kidney disease on renal replacement therapy before surgery
• death during or within 24 hours after surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of acute kidney injury based of RIFLE criteria	upto 7 days after surgery	serum creatinine, GFR were retrospectively retrieved from electrical medical record upto 7days after surgery.

Secondary Outcome Measures

Name	Time	Method
Risk factors of acute kidney injury	after diagnosis of acute kidney injury after operation (usually within 7 days after operation)	* age, sex, comorbidities; * serum creatinine, hemoglobin,mean arterial blood pressure; * CPB duration, aorta cross clamping duration, total circulatory arrest duration, operative procedures performed, amount of transfused blood components; * serum creatinine upto 7 days after surgery, mean arterial pressure, cardiac index, amount of transfused blood components in intensive care unit, ventiltor duration, ICU stay duration, renal replacement therapy, 30-day mortality

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of