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

Dissection of Thoracic Aorta Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190487
• Other study ID #: 3-2011-0076
• Status: Completed
• Phase: N/A
• First received: July 11, 2014
• Last updated: July 14, 2014
• Start date: May 2011
• Est. completion date: January 2013

Study information

• Verified date: July 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• thoracic aortic surgery due to dissection

Exclusion Criteria:

• chronic kidney disease on renal replacement therapy before surgery

• death during or within 24 hours after surgery

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Dissection of Thoracic Aorta

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of acute kidney injury based of RIFLE criteria	serum creatinine, GFR were retrospectively retrieved from electrical medical record upto 7days after surgery.	upto 7 days after surgery	No
Secondary	Risk factors of acute kidney injury	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	after diagnosis of acute kidney injury after operation (usually within 7 days after operation)	No