NCT05825703

Brief Summary

The primary goal of the study is to identify incidence and risk factors for PPMV in pediatric patients undergoing liver transplantation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

April 30, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

April 24, 2023

Status Verified

September 1, 2022

Enrollment Period

15 days

First QC Date

April 1, 2023

Last Update Submit

April 20, 2023

Conditions

Pediatric Liver Transplantation

Keywords

Pediatric Liver TransplantationPost-operative Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • Number of participants with post-operative mechanical ventilation

    To identify risk factors for prolonged post-operative mechanical ventilation (PPMV) in pediatric patients undergoing liver transplantation.

    24 hours

Secondary Outcomes (4)

  • Incidence of PPMV

    24 hours

  • total duration of icu stay and length of stay in hospital.

    From the day of admission to discharge or death, whichever comes first,upto 12 weeks

  • incidence of tracheostomy/re-intubation

    28 days post-op

  • incidence of 28 day mortality

    28 days post-op

Study Arms (2)

PPMV

GROUP OF PATIENT POPULATION WHO HAD PROLONGED POST-OPERATIVE MECHANICAL VENTILATION

NON PPMV

GROUP OF PATIENT POPULATION WHO DID NOT HAVE PROLONGED POST-OPERATIVE MECHANICAL VENTILATION

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All Pediatric patients aged \<17 years underwent liver transplant between 2010- March 2022 in the institute will be included in the study.

You may qualify if:

  • All Pediatric patients aged \<17 years underwent liver transplant between 2010- March 2022 in the institute will be included in the study.

You may not qualify if:

  • Patients who required mechanical ventilation during the 48 hr preceding surgery.
  • Older than 18 yr at the time of transplantation
  • Acute liver failure
  • Acute on chronic liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ILBS

New Delhi, 110070, India

Location

Study Design

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

Study Record Dates

First Submitted

April 1, 2023

First Posted

April 24, 2023

Study Start

April 30, 2023

Primary Completion

May 15, 2023

Study Completion

May 30, 2023

Last Updated

April 24, 2023

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)