Acute Kidney InjuryNCT06340607
Neohepatic Albumin-Bilirubin Scores on Renal Outcomes in Living-donor Liver Transplantation Recipients
An observational study of Acute Kidney Injury and Chronic Kidney Diseases, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This study investigates the association between post-reperfusion (neohepatic) ALBI scores and post-LT renal outcomes in living-donor LT (LDLT) recipients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury, Chronic Kidney Diseases, Graft Failure
- How many people
- 3,422 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jan 2012to 31 Dec 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: living donor liver transplantation recipients at Asan Medical Center, Seoul, Korea from January 2012 to December 2019
Who may be able to join
- living donor liver transplantation recipients (≥18 years)
Who cannot join
- preoperative serum creatinine (sCr) > 1.4 mg/dL, diagnosed CKD or hepatorenal syndrome (HRS), or hemodialysis at baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Neohepatic Albumin-Bilirubin Scores on Renal Outcomes Following Living-donor Liver Transplantation: Propensity Score Analysis
This study investigates the association between post-reperfusion (neohepatic) ALBI scores and post-LT renal outcomes in living-donor LT (LDLT) recipients.
Read the detailed description
Acute kidney injury (AKI) after liver transplantation (LT) significantly affects patient and graft outcomes. The Albumin-Bilirubin (ALBI) score, an objective and sensitive index of liver function, has potential applicability in predicting outcomes following LT. This study investigates the association between post-reperfusion (neohepatic) ALBI scores and post-LT renal outcomes in living-donor LT (LDLT) recipients.
- Conditions
- Acute Kidney Injury, Chronic Kidney Diseases, Graft Failure
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
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 with neohepatic ALBI ≥ -1.615 | The ALBI score was calculated using the formula: (log10bilirubin × 0.66) + (albumin × -0.085), where bilirubin is measured in μmol/L and albumin in g/L. Recipients with neohepatic (post-reperfusion) ALBI ≥ -1.615 | |
| Recipients with neohepatic ALBI < -1.615 | Recipients with neohepatic (post-reperfusion) ALBI < -1.615 |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute kidney injury
determined by change in sCr according to the Kidney Disease: Improving Global Outcomes (KDIGO) definition (increase in sCr of ≥26.5 mmol litre-1 within 48h or ≥1.5 times baseline within 7 days after surgery
Measured: within 7 days after surgery
Secondary outcomes (2)
chronic kidney injury
when renal function assessed by calculating estimated serum glomerular filtration using the abbreviated modification of diet in renal disease equation was <60 mL/min/1.73 m2 for 3 months or more, irrespective of cause
Measured: within 1 year after surgery
graft failure
graft failure
Measured: the graft failure at overall period (calculated from the date of surgery to the last follow-up) from the date of surgery (up to 10 years)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start5 Jan 2012
- Primary completion5 Jan 2020
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Asan 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
- 3,422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Gol Song, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340607
- Sponsor's protocol ID
- 2023-0561
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neohepatic Albumin-Bilirubin Scores on Renal Outcomes Following Living-donor Liver Transplantation: Propensity Score Analysis
- ClinicalTrials.gov ID
- NCT06340607
- Acronym / sponsor ID
- 2023-0561
- Conditions
- Acute Kidney Injury, Chronic Kidney Diseases, Graft Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,422 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 5 Jan 2012 (actual)
- Primary completion
- 5 Jan 2020 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Apr 2024 (actual)
- 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.
This study investigates the association between post-reperfusion (neohepatic) ALBI scores and post-LT renal outcomes in living-donor LT (LDLT) recipients.
Detailed description
Acute kidney injury (AKI) after liver transplantation (LT) significantly affects patient and graft outcomes. The Albumin-Bilirubin (ALBI) score, an objective and sensitive index of liver function, has potential applicability in predicting outcomes following LT. This study investigates the association between post-reperfusion (neohepatic) ALBI scores and post-LT renal outcomes in living-donor LT (LDLT) recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recipients with neohepatic ALBI ≥ -1.615 | – | –The ALBI score was calculated using the formula: (log10bilirubin × 0.66) + (albumin × -0.085), where bilirubin is measured in μmol/L and albumin in g/L. Recipients with neohepatic (post-reperfusion) ALBI ≥ -1.615 |
| Recipients with neohepatic ALBI < -1.615 | – | –Recipients with neohepatic (post-reperfusion) ALBI < -1.615 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- living donor liver transplantation recipients at Asan Medical Center, Seoul, Korea from January 2012 to December 2019
Key inclusion criteria (1 listed)
- living donor liver transplantation recipients (≥18 years)
Key exclusion criteria (1 listed)
- preoperative serum creatinine (sCr) > 1.4 mg/dL, diagnosed CKD or hepatorenal syndrome (HRS), or hemodialysis at baseline
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
Time frame: within 7 days after surgery
determined by change in sCr according to the Kidney Disease: Improving Global Outcomes (KDIGO) definition (increase in sCr of ≥26.5 mmol litre-1 within 48h or ≥1.5 times baseline within 7 days after surgery
2 secondary outcomes
chronic kidney injury
Time frame: within 1 year after surgery
graft failure
Time frame: the graft failure at overall period (calculated from the date of surgery to the last follow-up) from the date of surgery (up to 10 years)]
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 1 Apr 2024.
- Individual participant dataSharing planned: No
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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 Acute Kidney Injury and Chronic Kidney Diseases, run by Asan 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 1 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 1 Apr 2024. 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 (time frame: within 7 days after 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 1 Apr 2024.