- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02190487
Incidence and Risk Factors of Acute Kidney Injury After Thoracic Aortic Surgery Due to Dissection
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
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of
- Gangnam Severance Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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TAS group
patients who had thoracic aortic surgery due to dissection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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incidence of acute kidney injury based of RIFLE criteria
Time Frame: upto 7 days after surgery
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serum creatinine, GFR were retrospectively retrieved from electrical medical record upto 7days after surgery.
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upto 7 days after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Risk factors of acute kidney injury
Time Frame: after diagnosis of acute kidney injury after operation (usually within 7 days after operation)
|
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after diagnosis of acute kidney injury after operation (usually within 7 days after operation)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yon Hee Shim, Yonsei University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 3-2011-0076
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Clinical Trials on Dissection of Thoracic Aorta
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Baylor Research InstituteMedtronicTerminatedDissection of Thoracic AortaUnited States
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Xijing HospitalChanghai HospitalCompletedAorta Thoracic Ascending Dissection | Dissection of Descending AortaChina
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Assistance Publique - Hôpitaux de ParisNot yet recruitingChronic Dissection of Thoracic Aorta (Disorder)France
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W.L.Gore & AssociatesCMIC Co, Ltd. JapanRecruiting
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Vascutek Ltd.Federation of Medical SpecialtiesCompletedAneurysm Thoracic | Dissection of Thoracic Aorta | Pathology of the Thoracic Aorta | Pseudo-aneurysm, Thoracic | Intramural Haematoma of Thoracic Aorta | Penetrating Ulcer of Aorta (Disorder) | Rupture of the IsthmusFrance
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Ruijin HospitalRecruitingAscending Aortic DissectionChina
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Wuhan Asia Heart HospitalFu Wai Hospital, Beijing, ChinaCompletedDissection of Aorta, Thoracic | Aneurysm of Aorta, ThoracicChina
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Gangnam Severance HospitalCompletedDissecting Aneurysm of the Thoracic Aorta | Chronic Dissecting Aneurysm of Thoracic Aorta | Chronic Nontraumatic Dissection of Thoracic AortaKorea, Republic of
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Vascutek Ltd.RecruitingAortic Aneurysm | Aortic Diseases | Aortic Aneurysm and Dissection | Aneurysmal Disease | Aneurysm of Aorta, Thoracic | Aorta, Thoracic PathologiesUnited States, United Kingdom, Germany, Austria, Netherlands, Switzerland
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Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceCompleted