Clinical trial NCT05588271: A New Prediction Mode for Predicting the Risk of Pressure Injury in Patients Undergoing Liver Transplantation
Official title: Establishment of Risk Prediction Model for Pressure Injury in Patients Undergoing Liver Transplantation and Development of Prediction Tool
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplantation
Keywords: Pressure injury
Liver transplantation
Predictive mode
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing liver transplantation surgery

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Within 6 hours after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Xiaomei Chen, Master
role: PRINCIPAL_INVESTIGATOR
References: