Dissection of Thoracic AortaNCT02190487
Incidence and Risk Factors of Acute Kidney Injury After Thoracic Aortic Surgery Due to Dissection
An observational study of Dissection of Thoracic Aorta, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dissection of Thoracic Aorta
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who had thoracic aortic surgery due to dissection
Who may be able to join
- thoracic aortic surgery due to dissection
Who cannot join
- chronic kidney disease on renal replacement therapy before surgery
- death during or within 24 hours after surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dissection of Thoracic Aorta
- Medical subject headings
- Dissection, Thoracic Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TAS group | patients who had thoracic aortic surgery due to dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of acute kidney injury based of RIFLE criteria
serum creatinine, GFR were retrospectively retrieved from electrical medical record upto 7days after surgery.
Measured: upto 7 days after surgery
Secondary outcomes (1)
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
Measured: after diagnosis of acute kidney injury after operation (usually within 7 days after operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startMay 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dissection of Thoracic AortaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yon Hee Shim, Study director, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190487
- Sponsor's protocol ID
- 3-2011-0076
- Status last verified
- Jul 2014
- First submitted
- 11 Jul 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of Acute Kidney Injury After Thoracic Aortic Surgery Due to Dissection
- ClinicalTrials.gov ID
- NCT02190487
- Acronym / sponsor ID
- 3-2011-0076
- Conditions
- Dissection of Thoracic Aorta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAS group | – | –patients who had thoracic aortic surgery due to dissection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had thoracic aortic surgery due to dissection
Key inclusion criteria (1 listed)
- thoracic aortic surgery due to dissection
Key exclusion criteria (2 listed)
- chronic kidney disease on renal replacement therapy before surgery
- death during or within 24 hours after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Risk factors of acute kidney injury
Time frame: after diagnosis of acute kidney injury after operation (usually within 7 days after operation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yon Hee Shim study director
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dissection of Thoracic Aorta, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of acute kidney injury based of RIFLE criteria (time frame: upto 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.