Long-term Renal DysfunctionNCT02220283
Comparison of the Effects of Open and Endovascular Aortic Aneurysm Repair on Long-term Renal Function
An observational study of Long-term Renal Dysfunction, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Compare the renal complication of endovascular and open repair of acute aortic dissection by including patient treated at NTUH in 2010~2013. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Long-term Renal Dysfunction
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2014to Jun 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient underwent endovascular and open repair of aortic aneurysm at NTUH in 2010~2013
Patient underwent endovascular and open repair of aortic aneurysm at NTUH in 2010~2013 Age > 20 years old
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chun-Fu Lai, MD, +886-2-23123456 ext. 63921, d95421011@ntu.edu.tw
About this study
Compare the renal complication of endovascular and open repair of acute aortic dissection by including patient treated at NTUH in 2010~2013.
- Conditions
- Long-term Renal Dysfunction
- Keywords
- Acute kidney injury,aortic dissection
- Medical subject headings
- Acute Kidney Injury, Aortic Dissection
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term change of renal function (eGFR) after operation of aortic aneurysm
Measured: 30 days
Secondary outcomes (1)
Survival after operation of aortic aneurysm
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-term Renal DysfunctionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Fu Lai, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220283
- Sponsor's protocol ID
- 201405032RINB
- Status last verified
- Aug 2014
- First submitted
- 18 Aug 2014
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Open and Endovascular Aortic Aneurysm Repair on Long-term Renal Function
- ClinicalTrials.gov ID
- NCT02220283
- Acronym / sponsor ID
- 201405032RINB
- Conditions
- Long-term Renal Dysfunction
- Keywords
- Acute kidney injury,aortic dissection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 19 Aug 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.
Compare the renal complication of endovascular and open repair of acute aortic dissection by including patient treated at NTUH in 2010~2013.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient underwent endovascular and open repair of aortic aneurysm at NTUH in 2010~2013
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
Long-term change of renal function (eGFR) after operation of aortic aneurysm
Time frame: 30 days
1 secondary outcome
Survival after operation of aortic aneurysm
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 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.
Chun-Fu Lai, MD principal investigator
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 Long-term Renal Dysfunction, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 19 Aug 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Fu Lai, DM (+886-2-23123456 ext. 63921, d95421011@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term change of renal function (eGFR) after operation of aortic aneurysm (time frame: 30 days). 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 19 Aug 2014.