NCT06598228

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

September 12, 2024

Last Update Submit

September 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Graft survival

    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

Study Arms (3)

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

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

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

Interventions

no intervention

the group with persistent acute kidney injurythe group with transient acute kidney injurythe group without acute kidney injury

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin First Central Hospital

Tianjin, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the pediatric organ transplant unit

Study Record Dates

First Submitted

September 12, 2024

First Posted

September 19, 2024

Study Start

July 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

September 23, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations