Aortic SurgeryNCT01844219
Accuracy of Pre-existing Risk Scoring Models for Predicting Acute Kidney Injury in Patients Who Underwent Aortic Surgery Using a Gray Zone Approach
An observational study of Aortic Surgery and Postoperative Acute Kidney Injury, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Acute kidney injury after cardiac surgery has been reported to increase morbidity and mortality. Several risk scoring models for prediction of aortic kidney injury after cardiac surgery have been developed. However, predictive accuracy of these models is stil unclear. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Surgery, Postoperative Acute Kidney Injury
- What is being tested?
- elective or emergency aortic surgery (including ascending, arch, descending thoracic aorta)
- Type of treatment
- Surgery or procedure
- How many people
- 375 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Sep 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: Those who underwent elective or emergency aortic surgery in Samsung Medical Center during between 2004 and 2010.
Who may be able to join
- Those who underwent elective or emergency aortic surgery in Samsung Medical Center during between 2004 and 2010.
Who cannot join
- missing laboratory data
- preoperative hemodialysis
- death during or within 48 hours after surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center, Sungkyunkwan University, School of Medicine
Seoul, 135-710
About this study
Acute kidney injury after cardiac surgery has been reported to increase morbidity and mortality. Several risk scoring models for prediction of aortic kidney injury after cardiac surgery have been developed. However, predictive accuracy of these models is stil unclear. The aim of this study is to evaluate the accuracy of four pre-existing prediction models using a gray zone approach in patients who underwent aortic surgery in our institution.
Read the detailed description
Acute kidney injury after cardiac surgery has been reported to increase morbidity and mortality. Several risk scoring models for prediction of aortic kidney injury after cardiac surgery have been developed. However, predictive accuracy of these models is stil unclear. The aim of this study is to evaluate the accuracy of four pre-existing prediction models (AKICS, Wijeysundera, Mehta, and Thakar model)using a gray zone approach in patients who underwent aortic surgery in our institution. Based on receiver operating characteristic (ROC) curve analysis, we will construct a gray zone using the cut-off values with a sensitivity of < 90%, and a specificity of < 90% (diagnostic tolerance of 10%).
- Conditions
- Aortic Surgery, Postoperative Acute Kidney Injury
- Being tested
- elective or emergency aortic surgery (including ascending, arch, descending thoracic aorta)
- Keywords
- aortic surgery, acute kidney injury, gray zone approach
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elective or emergency aortic surgery (including ascending, arch, descending thoracic aorta)Procedure or surgery
Also called graft interposition of thoracic aorta
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent aortic surgery | Patients who underwent aortic surgery in Samsung Medical Center during the period between 2004 and 2010 Receives: Procedure: elective or emergency aortic surgery (including ascending, arch, descending thoracic aorta) |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of acute kidney injury
- abrupt (within 48 hours) reduction in kidney function currently defined as
- absolute increase in serum creatinine of more than or equal to 0.3 mg/dl (≥ 26.4 μmol/l),
- a percentage increase in serum creatinine of more than or equal to 50% (1.5-fold from baseline), or
- a reduction in urine output (documented oliguria of less than 0.5 ml/kg per hour for more than six hours)
Measured: within 48 hour after aortic surgery
Secondary outcomes (2)
Gray zone range of each risk scoring model
Thresholds with as a sensitivity of < 90% and a specificity of < 90%.
Measured: within 48 hours
Number of patients in the gray zone
Number of patients in the gray zone in each risk scoring model
Measured: within 48 hours after aortic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic SurgeryStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hwan Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844219
- Sponsor's protocol ID
- 2013-03-059-001
- Status last verified
- Dec 2013
- First submitted
- 28 Apr 2013
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Pre-existing Risk Scoring Models for Predicting Acute Kidney Injury in Patients Who Underwent Aortic Surgery Using a Gray Zone Approach
- ClinicalTrials.gov ID
- NCT01844219
- Acronym / sponsor ID
- 2013-03-059-001
- Conditions
- Aortic Surgery, Postoperative Acute Kidney Injury
- Keywords
- aortic surgery, acute kidney injury, gray zone approach
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 1 May 2013 (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 after cardiac surgery has been reported to increase morbidity and mortality. Several risk scoring models for prediction of aortic kidney injury after cardiac surgery have been developed. However, predictive accuracy of these models is stil unclear. The aim of this study is to evaluate the accuracy of four pre-existing prediction models using a gray zone approach in patients who underwent aortic surgery in our institution.
Detailed description
Acute kidney injury after cardiac surgery has been reported to increase morbidity and mortality. Several risk scoring models for prediction of aortic kidney injury after cardiac surgery have been developed. However, predictive accuracy of these models is stil unclear. The aim of this study is to evaluate the accuracy of four pre-existing prediction models (AKICS, Wijeysundera, Mehta, and Thakar model)using a gray zone approach in patients who underwent aortic surgery in our institution. Based on receiver operating characteristic (ROC) curve analysis, we will construct a gray zone using the cut-off values with a sensitivity of < 90%, and a specificity of < 90% (diagnostic tolerance of 10%).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent aortic surgery | – | Procedure: elective or emergency aortic surgery (including ascending, arch, descending thoracic aorta)Patients who underwent aortic surgery in Samsung Medical Center during the period between 2004 and 2010 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Those who underwent elective or emergency aortic surgery in Samsung Medical Center during between 2004 and 2010.
Key inclusion criteria (1 listed)
- Those who underwent elective or emergency aortic surgery in Samsung Medical Center during between 2004 and 2010.
Key exclusion criteria (3 listed)
- missing laboratory data
- preoperative hemodialysis
- death during or within 48 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elective or emergency aortic surgery (including ascending, arch, descending thoracic aorta)Also: graft interposition of thoracic aorta | Procedure or surgery | Patients who underwent aortic surgery |
Primary outcome
presence of acute kidney injury
Time frame: within 48 hour after aortic surgery
1. abrupt (within 48 hours) reduction in kidney function currently defined as 2. absolute increase in serum creatinine of more than or equal to 0.3 mg/dl (≥ 26.4 μmol/l), 3. a percentage increase in serum creatinine of more than or equal to 50% (1.5-fold from baseline), or 4. a reduction in urine output (documented oliguria of less than 0.5 ml/kg per hour for more than six hours)
2 secondary outcomes
Gray zone range of each risk scoring model
Time frame: within 48 hours
Number of patients in the gray zone
Time frame: within 48 hours after aortic surgery
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 25 Dec 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aortic Surgery and Postoperative Acute Kidney Injury, run by Samsung Medical Center 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 3 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 25 Dec 2013. 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?
presence of acute kidney injury (time frame: within 48 hour after aortic 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 25 Dec 2013; AzTrials last refreshed its copy on 6 Nov 2026.