Renal FunctionNCT02080065
Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Liver Transplantation
An observational study of Renal Function and Liver Transplantation, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The incidence of acute kidney injury after liver transplantation has been reported to be 17 to 95 percent, but no definite treatment has been reported yet. Therefore, it is important to identify and prevent reversible risk factors for acute kidney injury after liver transplantation. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Renal Function, Liver Transplantation
- What is being tested?
- living donor liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 573 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent living donor liver transplantation between 2010 and 2013
Who may be able to join
- Patients who underwent living donor liver transplantation between 2010 and 2013 in Samsung Medical Center
Who cannot join
- Incomplete data regarding pre- and postoperative creatinine and estimated Glomerular Filtration Rate
- patient who underwent retransplantation
Trial locations and contacts
1 site in 1 country.
About this study
The incidence of acute kidney injury after liver transplantation has been reported to be 17 to 95 percent, but no definite treatment has been reported yet. Therefore, it is important to identify and prevent reversible risk factors for acute kidney injury after liver transplantation. Previous studies have reported several preoperative clinical risk factors, but preoperative medication and intraoperative colloid administration and hemodynamic parameters have not been evaluated. Therefore, we attempt to evaluate perioperative risk factors and develop simplified clinical risk scoring model.
Read the detailed description
Ischemia/reperfusion injury occurs during graft harvesting, cold storage, and surgical procedures in liver transplantation. Ischemia/reperfusion injury in liver graft results in major organ damage including kidney, lung and heart as well as graft dysfunction. Graft dysfunction and renal injury after liver transplantation are major clinical issues and are associated with prognosis and low survival rate. The incidence of acute kidney injury after liver transplantation has been reported to be 17 to 95 percent, but no definite treatment has been reported yet. Therefore, it is important to identify and prevent reversible risk factors for acute kidney injury after liver transplantation. Previous studies have reported several preoperative clinical risk factors, but perioperative medication, metabolic variables (albumin, glucose, uric acid), intraoperative colloid administration and hemodynamic parameters have not been evaluated. In addition, a neutrophil-lymphocyte ratio (NLR), which has been reported to be related to systemic inflammation and associated with prognosis of cardiac and cancer patients, might be related to the development of AKI after LDLT. Therefore, we attempt to evaluate these perioperative risk factors and develop simplified clinical risk scoring model.
- Conditions
- Renal Function, Liver Transplantation
- Being tested
- living donor liver transplantation
- Keywords
- risk factor, acute kidney injury, liver transplantation, postoperative renal function
- 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.
living donor liver transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| liver transplantation | patients who underwent living donor liver transplantation during between 2007 and 2013 Receives: Procedure: living donor liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute kidney injury as defined by RIFLE criteria
acute kidney injury as defined by RIFLE criteria
Measured: during 7 days after transplantation
Secondary outcomes (4)
incidence of renal replacement therapy
renal replacement therapy
Measured: during one month after transplantation
incidence of acute rejection of graft
incidence of acute rejection of graft
Measured: during one month after transplantation
incidence of initial poor graft function
incidence of initial poor graft function
Measured: during one month after transplantation
incidence of retransplantation
incidence of retransplantation
Measured: during one month after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FunctionStudies 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
- 573 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WonHo Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080065
- Sponsor's protocol ID
- 2013-12-080
- Status last verified
- Aug 2015
- First submitted
- 4 Mar 2014
- Last updated
- 28 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Liver Transplantation
- ClinicalTrials.gov ID
- NCT02080065
- Acronym / sponsor ID
- 2013-12-080
- Conditions
- Renal Function, Liver Transplantation
- Keywords
- risk factor, acute kidney injury, liver transplantation, postoperative renal function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 573 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Mar 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.
The incidence of acute kidney injury after liver transplantation has been reported to be 17 to 95 percent, but no definite treatment has been reported yet. Therefore, it is important to identify and prevent reversible risk factors for acute kidney injury after liver transplantation. Previous studies have reported several preoperative clinical risk factors, but preoperative medication and intraoperative colloid administration and hemodynamic parameters have not been evaluated. Therefore, we attempt to evaluate perioperative risk factors and develop simplified clinical risk scoring model.
Detailed description
Ischemia/reperfusion injury occurs during graft harvesting, cold storage, and surgical procedures in liver transplantation. Ischemia/reperfusion injury in liver graft results in major organ damage including kidney, lung and heart as well as graft dysfunction. Graft dysfunction and renal injury after liver transplantation are major clinical issues and are associated with prognosis and low survival rate. The incidence of acute kidney injury after liver transplantation has been reported to be 17 to 95 percent, but no definite treatment has been reported yet. Therefore, it is important to identify and prevent reversible risk factors for acute kidney injury after liver transplantation. Previous studies have reported several preoperative clinical risk factors, but perioperative medication, metabolic variables (albumin, glucose, uric acid), intraoperative colloid administration and hemodynamic parameters have not been evaluated. In addition, a neutrophil-lymphocyte ratio (NLR), which has been reported to be related to systemic inflammation and associated with prognosis of cardiac and cancer patients, might be related to the development of AKI after LDLT. Therefore, we attempt to evaluate these perioperative risk factors and develop simplified clinical risk scoring model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver transplantation | – | Procedure: living donor liver transplantationpatients who underwent living donor liver transplantation during between 2007 and 2013 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent living donor liver transplantation between 2010 and 2013
Key inclusion criteria (1 listed)
- Patients who underwent living donor liver transplantation between 2010 and 2013 in Samsung Medical Center
Key exclusion criteria (2 listed)
- Incomplete data regarding pre- and postoperative creatinine and estimated Glomerular Filtration Rate
- patient who underwent retransplantation
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 |
|---|---|---|
| living donor liver transplantation | Procedure or surgery | liver transplantation |
Primary outcome
acute kidney injury as defined by RIFLE criteria
Time frame: during 7 days after transplantation
acute kidney injury as defined by RIFLE criteria
4 secondary outcomes
incidence of renal replacement therapy
Time frame: during one month after transplantation
incidence of acute rejection of graft
Time frame: during one month after transplantation
incidence of initial poor graft function
Time frame: during one month after transplantation
incidence of retransplantation
Time frame: during one month after transplantation
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 28 Aug 2015.
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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 Renal Function and Liver Transplantation, 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 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 28 Aug 2015. 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 as defined by RIFLE criteria (time frame: during 7 days after transplantation). 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 28 Aug 2015.