Acute Kidney InjuryNCT06750770
Development and Validation of a Clinical Risk Prediction Model for Early Acute Kidney Injury Within 48 Hours After Liver Transplantation
An observational study of Acute Kidney Injury and Liver Transplantation, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
Acute kidney injury (AKI) is a common complication after liver transplantation, with an incidence of 12.7-95%. The occurrence of acute kidney injury after transplantation is related to the poor prognosis of patients, which significantly increases the length of hospital stay, hospitalization costs and mortality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Liver Transplantation, Model
- What is being tested?
- KDIGO CRITERIA
- How many people
- 453 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 15 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion criteria for our study comprised consecutive patients undergoing liver transplantation at Tsinghua University Beijing Changgung Hospital from January 1, 2018, to October 15, 2022. Exclusion criteria were as follows: (1) under 18 years of age (2) post-renal transplant (3) liver combined with other organ transplants (4) preoperative requirement for renal replacement therapy (RRT) (5) patients with second or multiple liver transplants (6) preoperative estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, and (7) patients with severe illness leading to termination of surgery.
Who may be able to join
- patients who underwent liver transplantation in Beijing Tsinghua Changgung Hospital.
Who cannot join
- (1) under 18 years of age (2) post-renal transplant (3) liver combined with other organ transplants (4) preoperative requirement for renal replacement therapy (RRT) (5) patients with second or multiple liver transplants (6) preoperative estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, and (7) patients with severe illness leading to termination of surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a Clinical Risk Prediction Model for Early Acute Kidney Injury After Liver Transplantation
Acute kidney injury (AKI) is a common complication after liver transplantation, with an incidence of 12.7-95%. The occurrence of acute kidney injury after transplantation is related to the poor prognosis of patients, which significantly increases the length of hospital stay, hospitalization costs and mortality of patients. Early recognition of acute kidney injury after transplantation is of great significance. Therefore, by collecting preoperative and intraoperative variables, this study intends to establish and verify a clinical risk prediction model for early AKI after liver transplantation, in order to provide clinicians with a visual prediction tool to identify patients with high risk of early AKI after liver transplantation immediately after the operation, so as to start clinical intervention as soon as possible and improve the prognosis of patients.
- Conditions
- Acute Kidney Injury, Liver Transplantation, Model
- Being tested
- KDIGO CRITERIA
- Keywords
- acute kidney injury, liver transplantation, model, validation
- 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.
KDIGO CRITERIADiagnostic test
2012 KDIGO DIAGNOSTIC CRITERIA
| Study group | Role | What they receive |
|---|---|---|
| AKI group | Participants who were diagnosed acute kidney injury(AKI) Receives: Diagnostic Test: KDIGO CRITERIA | |
| Non-AKI group | Participants who were not diagnosed AKI Receives: Diagnostic Test: KDIGO CRITERIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
KDIGO criteria (Kidney Disease: Improving Global Outcomes) used to evaluate postoperative AKI in liver transplant patients.
Diagnosed according to 2012 KDIGO criteria: serum creatinine rise ≥50% or ≥26.5 µmol/L within 48 hours post-surgery. Baseline creatinine was the most recent preoperative value, with kidney function assessed by eGFR.
Measured: 48 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jan 2018
- Primary completion15 Oct 2022
- Study completion15 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 Beijing Tsinghua Chang Gung 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
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750770
- Sponsor's protocol ID
- 22216-4-01
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Clinical Risk Prediction Model for Early Acute Kidney Injury After Liver Transplantation
- ClinicalTrials.gov ID
- NCT06750770
- Acronym / sponsor ID
- 22216-4-01
- Conditions
- Acute Kidney Injury, Liver Transplantation, Model
- Keywords
- acute kidney injury, liver transplantation, model, validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 27 Dec 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.
Acute kidney injury (AKI) is a common complication after liver transplantation, with an incidence of 12.7-95%. The occurrence of acute kidney injury after transplantation is related to the poor prognosis of patients, which significantly increases the length of hospital stay, hospitalization costs and mortality of patients. Early recognition of acute kidney injury after transplantation is of great significance. Therefore, by collecting preoperative and intraoperative variables, this study intends to establish and verify a clinical risk prediction model for early AKI after liver transplantation, in order to provide clinicians with a visual prediction tool to identify patients with high risk of early AKI after liver transplantation immediately after the operation, so as to start clinical intervention as soon as possible and improve the prognosis of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI group | – | Diagnostic Test: KDIGO CRITERIAParticipants who were diagnosed acute kidney injury(AKI) |
| Non-AKI group | – | Diagnostic Test: KDIGO CRITERIAParticipants who were not diagnosed AKI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion criteria for our study comprised consecutive patients undergoing liver transplantation at Tsinghua University Beijing Changgung Hospital from January 1, 2018, to October 15, 2022. Exclusion criteria were as follows: (1) under 18 years of age (2) post-renal transplant (3) liver combined with other organ transplants (4) preoperative requirement for renal replacement therapy (RRT) (5) patients with second or multiple liver transplants (6) preoperative estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, and (7) patients with severe illness leading to termination of surgery.
Key inclusion criteria (1 listed)
- patients who underwent liver transplantation in Beijing Tsinghua Changgung Hospital.
Key exclusion criteria (1 listed)
- (1) under 18 years of age (2) post-renal transplant (3) liver combined with other organ transplants (4) preoperative requirement for renal replacement therapy (RRT) (5) patients with second or multiple liver transplants (6) preoperative estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, and (7) patients with severe illness leading to termination of 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 |
|---|---|---|
| KDIGO CRITERIA2012 KDIGO DIAGNOSTIC CRITERIA | Diagnostic test | AKI group, Non-AKI group |
Primary outcome
KDIGO criteria (Kidney Disease: Improving Global Outcomes) used to evaluate postoperative AKI in liver transplant patients.
Time frame: 48 hours post-surgery
Diagnosed according to 2012 KDIGO criteria: serum creatinine rise ≥50% or ≥26.5 µmol/L within 48 hours post-surgery. Baseline creatinine was the most recent preoperative value, with kidney function assessed by eGFR.
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 27 Dec 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 Liver Transplantation, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
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 27 Dec 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 China. 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?
KDIGO criteria (Kidney Disease: Improving Global Outcomes) used to evaluate postoperative AKI in liver transplant patients. (time frame: 48 hours post-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 27 Dec 2024.