Liver TransplantationPMPRPIULTNCT05588271
A New Prediction Mode for Predicting the Risk of Pressure Injury in Patients Undergoing Liver Transplantation
An observational study of Liver Transplantation, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Exposures
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2022to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients undergoing liver transplantation surgery
Who may be able to join
- undergoing liver transplantation surgery (i.e., living-donor liver transplantation and deceased donor liver transplantation)
- patients undergoing the first surgery during their hospitalization
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, 200127
Xiaomei Chen, Master, 8613918964297, xiaomeichen1989@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Transplantation
- Being tested
- Exposures
- Keywords
- Pressure injury, Liver transplantation, Predictive mode
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExposuresOther
This study is an observational study.Exposure factors is patients with pressure injury.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Exposures | |
| Group without PIs | Skin in good condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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
Measured: Within 6 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start20 Oct 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaomei Chen, Master, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588271
- Sponsor's protocol ID
- KY2022-178-B
- Acronym
- PMPRPIULT
- Status last verified
- Dec 2022
- First submitted
- 18 Oct 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Risk Prediction Model for Pressure Injury in Patients Undergoing Liver Transplantation and Development of Prediction Tool
- ClinicalTrials.gov ID
- NCT05588271
- Acronym / sponsor ID
- PMPRPIULT / KY2022-178-B
- Conditions
- Liver Transplantation
- Keywords
- Pressure injury, Liver transplantation, Predictive mode
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with PIs | – | Other: Exposuresstage 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 |
| Group without PIs | – | –Skin in good condition |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing liver transplantation surgery
Key inclusion criteria (2 listed)
- undergoing liver transplantation surgery (i.e., living-donor liver transplantation and deceased donor liver transplantation)
- patients undergoing the first surgery during their hospitalization
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExposuresThis study is an observational study.Exposure factors is patients with pressure injury. | Other | Group with PIs |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
Related trials for Liver Transplantation
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaomei Chen, Master principal investigator
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zheying Chen, Master (008613601853150, tougao2022@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Within 6 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.