A New Prediction Mode for Predicting the Risk of Pressure Injury in Patients Undergoing Liver Transplantation (PMPRPIULT)

December 26, 2022 updated by: RenJi Hospital

Establishment of Risk Prediction Model for Pressure Injury in Patients Undergoing Liver Transplantation and Development of Prediction Tool

Pediatric population is at a high-risk of pressure injury (PI). Patients undergoing liver transplantation are more prone to PIs compared with other types of surgery. However, there is a lack of sensitive and specific assessment tools for the risk of PI in patients undergoing liver transplantation. How to accurately predict the incidence of PI in patients undergoing liver transplantation is needs to be urgently eliminated. The study is conducted in the Renji Hospital, School of Medicine, Shanghai Jiaotong University which is the largest liver transplantation center in China.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Data of 1200 eligible patients undergoing liver transplantation between July 2018 and June 2021 are selected.The sample size was randomly divided into 70% discovery set and 30% validation set according to 7:3. 70% of the discovery dataset are used for the establishment of risk prediction model. The univariate analysis is used to evaluate PI-associated risk factors. In addition, a multivariate logistic regression model is developed using selected variables and P<0.05 in the univariate analysis is used to identify independent risk factors for PIs. The odds ratio for each independent variable is determined with a 95% confidence interval. Finally, a nomogram of predictive model is generated on the basis of the results of multivariate analysis.Discrimination capability, calibration degree, and clinical value will be used to verify the efficacy of the prediction model. This study develops and validates a prediction model for predicting the risk of PI in patients undergoing liver transplantation. Using this prediction model, we will develop decision-support systems to prevent PI in the future.

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiaotong University
        • Contact:

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
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients undergoing liver transplantation surgery

Description

Inclusion Criteria:

  • undergoing liver transplantation surgery (i.e., living-donor liver transplantation and deceased donor liver transplantation)
  • patients undergoing the first surgery during their hospitalization

Exclusion Criteria:

  • a history of PI before undergoing surgery
  • patients with skin disease that could affect observation of skin and the outcome
  • patients who died during surgery

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group with PIs
stage 1pressure injury: non-blanchable erythema of intact skin; stage 2 pressure injury: partial-thickness skin loss with exposed dermis; stage 3 pressure injury: full-thickness skin loss; stage 4 pressure injury: full-thickness skin and tissue loss; unstageable pressure injury: obscured full-thickness skin and tissue loss; deep tissue pressure injury: persistent non-blanchable deep red, maroon or purple discoloration
Other: Exposures
This study is an observational study.Exposure factors is patients with pressure injury.
Group without PIs
Skin in good condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
According to The National Pressure Ulcer Advisory Panel (NPUAP) defined the definition and stage of Pressure Injury to Judge whether pressure injury occurs on skin under pressure.
Time Frame: Within 6 hours after operation

Definition:A pressure injury is localized damage to the skin and underlying soft tissue usually over a bony prominence or related to a medical or other device. The injury can present as intact skin or an open ulcer and may be painful. The injury occurs as a result of intense and/or prolonged pressure or pressure in combination with shear. The tolerance of soft tissue for pressure and shear may also be affected by microclimate, nutrition, perfusion, co-morbidities and condition of the soft tissue.

NPUAP Pressure Injury Stages:stage 1pressure injury: non-blanchable erythema of intact skin; stage 2 pressure injury: partial-thickness skin loss with exposed dermis; stage 3 pressure injury: full-thickness skin loss; stage 4 pressure injury: full-thickness skin and tissue loss; unstageable pressure injury: obscured full-thickness skin and tissue loss; deep tissue pressure injury: persistent non-blanchable deep red, maroon or purple discoloration
Within 6 hours after operation

Collaborators and Investigators

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

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Xiaomei Chen, Master, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

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)

October 20, 2022

Primary Completion (Anticipated)

December 30, 2024

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 20, 2022

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 26, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2022-178-B

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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