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

NCT ID: NCT05588271

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-20

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Liver Transplantation

Keywords

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Pressure injury Liver transplantation Predictive mode

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Exposures

Intervention Type OTHER

This study is an observational study.Exposure factors is patients with pressure injury.

Group without PIs

Skin in good condition

No interventions assigned to this group

Interventions

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Exposures

This study is an observational study.Exposure factors is patients with pressure injury.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaomei Chen, Master

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

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Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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zheying Chen, Master

Role: CONTACT

Phone: 008613601853150

Email: [email protected]

Xiaomei Chen, Master

Role: CONTACT

Phone: 008613918964297

Email: [email protected]

Facility Contacts

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Xiaomei Chen, Master

Role: primary

Other Identifiers

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KY2022-178-B

Identifier Type: -

Identifier Source: org_study_id