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

July 14, 2014 updated by: Yonsei University

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who had thoracic aortic surgery due to dissection

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
TAS group
patients who had thoracic aortic surgery due to dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of acute kidney injury based of RIFLE criteria
Time Frame: upto 7 days after surgery
serum creatinine, GFR were retrospectively retrieved from electrical medical record upto 7days after surgery.
upto 7 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors of acute kidney injury
Time Frame: 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
after diagnosis of acute kidney injury after operation (usually within 7 days after operation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Yon Hee Shim, Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (Estimate)

July 15, 2014

Study Record Updates

Last Update Posted (Estimate)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 14, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 3-2011-0076

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dissection of Thoracic Aorta

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