Postoperative Acute Kidney InjuryNCT06598228
Acute Kidney Injury and Recovery Mode in Pediatric Liver Transplantation
An observational study of Postoperative Acute Kidney Injury and Pediatric Liver Transplantation, run by Tianjin First Central Hospital at 1 site in China.
Trial summary
Acute kidney injury (AKI) is a common complication after pediatric liver transplantation (PLT), and renal impairment after LT has proven to be related with increased graft failure and mortality. The recovery mode of kidney injury after PLT has not been systematically studied. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Postoperative Acute Kidney Injury, Pediatric Liver Transplantation
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Sep 2024
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study was conducted on pediatric patients (aged ≤18 years) who received liver transplantation at Tianjin First Central Hospital in China between January 1, 2014 and December 31, 2018
Who may be able to join
- Patients who received a liver transplant for the first time.
- Patients who were younger than 18 years of age at the time of transplant.
Who cannot join
- Patients with incomplete clinical data.
- Patients with less than 5 years of follow-up.
- Patients who have combined multiple solid organ transplants.
- Patients with preoperative renal impairment (eGFR<60ml/min/1.73 m2 or prior renal replacement therapy).
Trial locations and contacts
1 site in 1 country.
About this study
Acute kidney injury (AKI) is a common complication after pediatric liver transplantation (PLT), and renal impairment after LT has proven to be related with increased graft failure and mortality. The recovery mode of kidney injury after PLT has not been systematically studied. Therefore, in this study the investigators aimed to systematically evaluate prognosis of AKI after PLT, combine the recovery mode of AKI with related risk factors, and establish a relationship between AKI and CKD.
- Being tested
- No Intervention: Observational Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| the group without acute kidney injury | Patients not diagnosed with acute kidney injury according to KDIGO(Kidney Disease: Improving Global Outcomes) criteria Receives: Other: No Intervention: Observational Cohort | |
| the group with transient acute kidney injury | Patients diagnosed with acute kidney injury according to KDIGO(Kidney Disease: Improving Global Outcomes) criteria and recovered within 48h Receives: Other: No Intervention: Observational Cohort | |
| the group with persistent acute kidney injury | Patients diagnosed with acute kidney injury according to KDIGO(Kidney Disease: Improving Global Outcomes) criteria and sustained over 48h Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft survival
Loss of graft is defined as patient death or secondary transplantation
Measured: Based on the most recent follow-up before December 31, 2023. The investigators collected clinical data of patients from 2014 to 2018, and followed enrolled participants until at least 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jul 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin First Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Gao, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598228
- Sponsor's protocol ID
- 20240903-1
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 23 Sep 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 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury and Recovery Mode in Pediatric Liver Transplantation
- ClinicalTrials.gov ID
- NCT06598228
- Acronym / sponsor ID
- 20240903-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Tianjin First Central HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 19 Sep 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 pediatric liver transplantation (PLT), and renal impairment after LT has proven to be related with increased graft failure and mortality. The recovery mode of kidney injury after PLT has not been systematically studied. Therefore, in this study the investigators aimed to systematically evaluate prognosis of AKI after PLT, combine the recovery mode of AKI with related risk factors, and establish a relationship between AKI and CKD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the group without acute kidney injury | – | Other: No Intervention: Observational CohortPatients not diagnosed with acute kidney injury according to KDIGO(Kidney Disease: Improving Global Outcomes) criteria |
| the group with transient acute kidney injury | – | Other: No Intervention: Observational CohortPatients diagnosed with acute kidney injury according to KDIGO(Kidney Disease: Improving Global Outcomes) criteria and recovered within 48h |
| the group with persistent acute kidney injury | – | Other: No Intervention: Observational CohortPatients diagnosed with acute kidney injury according to KDIGO(Kidney Disease: Improving Global Outcomes) criteria and sustained over 48h |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study was conducted on pediatric patients (aged ≤18 years) who received liver transplantation at Tianjin First Central Hospital in China between January 1, 2014 and December 31, 2018
Key inclusion criteria (2 listed)
- Patients who received a liver transplant for the first time.
- Patients who were younger than 18 years of age at the time of transplant.
Key exclusion criteria (4 listed)
- Patients with incomplete clinical data.
- Patients with less than 5 years of follow-up.
- Patients who have combined multiple solid organ transplants.
- Patients with preoperative renal impairment (eGFR<60ml/min/1.73 m2 or prior renal replacement therapy).
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 |
|---|---|---|
| No Intervention: Observational Cohortno intervention | Other | the group with persistent acute kidney injury, the group with transient acute kidney injury, the group without acute kidney injury |
Primary outcome
Graft survival
Time frame: Based on the most recent follow-up before December 31, 2023. The investigators collected clinical data of patients from 2014 to 2018, and followed enrolled participants until at least 5 years after surgery
Loss of graft is defined as patient death or secondary 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 23 Sep 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 Postoperative Acute Kidney Injury and Pediatric Liver Transplantation, run by Tianjin First Central 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 2 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 23 Sep 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?
Graft survival (time frame: Based on the most recent follow-up before December 31, 2023. The investigators collected clinical data of patients from 2014 to 2018, and followed enrolled participants until at least 5 years 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 23 Sep 2024.