Liver TransplantationNCT02489474
Association of Genetic Polymorphism and Acute Kidney Injury After Liver Transplantation
An observational study of Liver Transplantation, run by Yonsei University at 1 site in South Korea.
Trial summary
Some of the liver transplantation recipients experience postoperative acute kidney injury due to various causes including genetic factors. Prevention of postoperative acute kidney injury is essential for postoperative care in liver transplantation recipients. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Transplantation
- How many people
- 124 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jul 2015to 16 Nov 2017
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients scheduled for liver transplantation
Who may be able to join
- 1) adult patients scheduled for liver transplantation
Who cannot join
- Patients on dialysis
- patients not able to read, or understand the consent form
- ethnicity, other than asian
- patients refusal
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, 120-752
About this study
Some of the liver transplantation recipients experience postoperative acute kidney injury due to various causes including genetic factors. Prevention of postoperative acute kidney injury is essential for postoperative care in liver transplantation recipients. The aim of this study is to investigate the relationship between gene polymorphisms which have been known to be associated with postoperative acute kidney injury, and the occurrence of acute kidney injury after liver transplantation.
- Conditions
- Liver Transplantation
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 |
|---|---|---|
| Recipients undergoing liver transplantation | Patients undergoing liver transplantation will be included and followed up during the first 72 hours post-liver transplantation in order to confirm the development of acute kidney injury. The patients will be divided into two groups (AKI group vs. non-AKI group) according to the development of acute kidney injury. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury after liver transplantation
The development of acute kidney injury is defined by the following definition: 50% increase in SCr from the baseline (preoperative value) or a 0.3 mg/dl increase from baseline within 48 h without urine output. The development of acute kidney injury after liver transplantation could correlate with gene polymorphisms, which have been known to be associated with postoperative acute kidney injury.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study start10 Jul 2015
- Primary completion16 Nov 2017
- Study completion16 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies 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
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489474
- Sponsor's protocol ID
- 4-2015-0411
- Status last verified
- Jul 2018
- First submitted
- 1 Jul 2015
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Genetic Polymorphism and Acute Kidney Injury After Liver Transplantation
- ClinicalTrials.gov ID
- NCT02489474
- Acronym / sponsor ID
- 4-2015-0411
- Conditions
- Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 Jul 2015 (actual)
- Primary completion
- 16 Nov 2017 (actual)
- Study completion
- 16 Nov 2017 (actual)
- First posted
- 3 Jul 2015 (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.
Some of the liver transplantation recipients experience postoperative acute kidney injury due to various causes including genetic factors. Prevention of postoperative acute kidney injury is essential for postoperative care in liver transplantation recipients. The aim of this study is to investigate the relationship between gene polymorphisms which have been known to be associated with postoperative acute kidney injury, and the occurrence of acute kidney injury after liver transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recipients undergoing liver transplantation | – | –Patients undergoing liver transplantation will be included and followed up during the first 72 hours post-liver transplantation in order to confirm the development of acute kidney injury. The patients will be divided into two groups (AKI group vs. non-AKI group) according to the development of acute kidney injury. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for liver transplantation
Key inclusion criteria (1 listed)
- 1) adult patients scheduled for liver transplantation
Key exclusion criteria (4 listed)
- Patients on dialysis
- patients not able to read, or understand the consent form
- ethnicity, other than asian
- patients refusal
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
Acute kidney injury after liver transplantation
Time frame: 72 hours
The development of acute kidney injury is defined by the following definition: 50% increase in SCr from the baseline (preoperative value) or a 0.3 mg/dl increase from baseline within 48 h without urine output. The development of acute kidney injury after liver transplantation could correlate with gene polymorphisms, which have been known to be associated with postoperative acute kidney injury.
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 17 Jul 2018.
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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 Liver Transplantation, 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 4 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 17 Jul 2018. 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?
Acute kidney injury after liver transplantation (time frame: 72 hours). 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 17 Jul 2018.