NCT02190487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
Last Updated

July 16, 2014

Status Verified

July 1, 2014

Enrollment Period

1.7 years

First QC Date

July 11, 2014

Last Update Submit

July 14, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Risk factors of acute kidney injury

    after diagnosis of acute kidney injury after operation (usually within 7 days after operation)

Study Arms (1)

TAS group

patients who had thoracic aortic surgery due to dissection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who had thoracic aortic surgery due to dissection

You may qualify if:

  • thoracic aortic surgery due to dissection

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Dissection, Thoracic Aorta

Condition Hierarchy (Ancestors)

Aortic DissectionDissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic Diseases

Study Officials

  • Yon Hee Shim

    Yonsei University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 15, 2014

Study Start

May 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 16, 2014

Record last verified: 2014-07

Locations