NCT06162260

Brief Summary

To explore the risk factors of unplanned return to Intensive Care Unit (ICU) in pediatric liver transplant recipients, and to provide data support for the transfer of pediatric liver transplant recipients from ICU after surgery, so as to avoid unplanned ICU return and reduce the mortality of patients during hospitalization.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,575

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Status
unknown

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

First Submitted

Initial submission to the registry

December 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2024

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

12 months

First QC Date

December 1, 2023

Last Update Submit

December 1, 2023

Conditions

Keywords

readdmission;ICU;transplantation

Outcome Measures

Primary Outcomes (1)

  • Unplanned return to the ICU

    ICU re-entry occurred within the same hospital cycle after the first ICU transfer after liver transplantation

    01/01/2018-31/12/2021

Study Arms (2)

observation group

(1) Liver transplantation was performed between January 1, 2019 and December 31, 2019; (2) Age \< 18 years; (3) The patient was admitted to ICU for the first time due to postoperative monitoring after liver transplantation; (4) Survival on first transfer from ICU.

Procedure: ICU readmission

matched group

(1) Liver transplantation was performed between January 1, 2019 and December 31, 2019; (2) Age \< 18 years; (3) The patient was admitted to ICU for the first time due to postoperative monitoring after liver transplantation; (4) survive the first transfer from ICU; (5) No ICU re-entry occurred in the same hospitalization period after liver transplantation.

Interventions

Children who underwent liver transplantation at Renji Hospital, Shanghai Jiao Tong University School of Medicine from January 1, 2018 to December 31, 2021 and were transferred out of ICU for the first time during the same hospitalization cycle.

observation group

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children who underwent liver transplantation at Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from Jan 1, 2018 to Dec 31, 2021.

You may qualify if:

  • (1) Liver transplantation was performed from January, 2018 to December, 31, 2021.21;
  • (2) Age \< 18 years;
  • (3) The patient was admitted to ICU for the first time due to postoperative monitoring after liver transplantation;
  • (4) Survival on first transfer from ICU.

You may not qualify if:

  • (1) Death during ICU stay after liver transplantation;
  • (2) non-first-time recipients of liver transplantation;
  • (3) Patients with complex conditions who were transferred to ICU for life support (such as mechanical ventilation, CRRT, etc.) before operation;
  • (4) Patients admitted to ICU by appointment for surgical reasons.
  • (5) Patients forcibly transferred from ICU.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2023

First Posted

December 8, 2023

Study Start

December 1, 2023

Primary Completion

November 29, 2024

Study Completion

December 28, 2024

Last Updated

December 8, 2023

Record last verified: 2023-12