Acute Kidney Injury and Recovery Mode in Pediatric Liver Transplantation

September 19, 2024 updated by: Wei Gao, Tianjin First Central Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China
        • Tianjin First Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • Patients who received a liver transplant for the first time.
  • Patients who were younger than 18 years of age at the time of transplant.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
the group without acute kidney injury
Patients not diagnosed with acute kidney injury according to KDIGO(Kidney Disease: Improving Global Outcomes) criteria
Other: No Intervention: Observational Cohort
no intervention
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
Other: No Intervention: Observational Cohort
no intervention
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
Other: No Intervention: Observational Cohort
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin First Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20240903-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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