Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162260
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-12-01
Brief Title:
Unplanned ICU Readmission for Pediatric Liver Transplantation
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
Analyse Des Facteurs de Risque Pour la réintégration Non planifiée Post-opératoire de Patients transplantés du Foie Chez lEnfant
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To explore the risk factors of unplanned return to Intensive Care Unit ICU in pediatric liver transplant recipients and to provide data support for the transfer of pediatric liver transplant recipients from ICU after surgery so as to avoid unplanned ICU return and reduce the mortality of patients during hospitalization
Detailed Description:
In recent years with the progress of medical level pediatric liver transplantation has been used in a variety of pediatric end-stage liver diseases such as intrahepatic cholestasis metabolic diseases acute liver failure liver tumors and other diseases It is the only effective way to treat pediatric end-stage liver diseases The maturity of surgical techniques and the application of immunosuppressants have greatly improved the overall survival rate of children after liver transplantation In some developed countries the 1-year and 5-year survival rates of children after liver transplantation can reach more than 80 Pediatric liver transplantation is difficult and the postoperative condition is complicated and changes rapidly which requires Intensive Care Unit ICU for intensive monitoring However unplanned reentry to the ICU occurs in some pediatric liver transplant recipients who have been transferred out of the ICU and need to be transferred again because of a change in their condition Unplanned ICU return leads to increased mortality longer hospital stay and higher hospital costs For example Rosenberg et al 5 reported that the comprehensive ICU re-entry rate was 4-14 average 7 the average length of stay was more than twice that of non-re-entrants and the mortality rate was 2-10 times that of non-re-entrants Kramer et al 8 analyzed 229375 patients in 97 intensive care units from 2001 to 2009 and the re-entry rate was 61 The average length of stay of the re-entry patients was 25 times higher than that of the non-re-entry patients and the mortality rate was 4 times higher than that of the non-re-entry patients Therefore unplanned ICU re-entry is a rare but serious event which has important clinical significance for the study of unplanned ICU re-entry
There are significant differences in ICU re-entry rates among liver transplant recipients in different studies Young Gon Son et al reported that 58 68 patients 1181 patients of the enrolled patients underwent ICU re-entry after liver transplantation A case-control study at a Canadian medical center showed that 14 of 369 patients who received liver transplants at the center between 2005 and 2012 had ICU re-entry They had a longer first hospital stay P0001 and a lower cumulative survival rate of 1 month to 2 years P0001 The study by Mark et al showed that ICU re-entry occurred in 34 of 167 liver transplant recipients Several studies of risk factors for ICU return after liver transplantation have also shown mixed results For example Levy et al showed that older age and more intraoperative blood transfusion in liver transplant recipients were positively associated with ICU return Filipe et al showed that more than 20 breaths per minute at ICU discharge after liver transplantation was an independent risk factor for ICU return during the same hospitalization At present studies on ICU re-entry rate and risk factors after liver transplantation mostly focus on adult liver transplant recipients There are no reports on risk factors for ICU return after liver transplantation in children Some reports of PICUs return were found For example Angela S statistically analyzed 117923 children admitted to 73 PICUs from 2005 to 2008 The ICU re-entry rate was 37 of which 3814 occurred early ICU re-entry within 48 hours Patient characteristics strongly associated with an increased risk of early readmission included age 6 months acute respiratory and renal disease and underlying chronic conditions such as liver disease bone marrow transplantation and airway stenosis Afrothite Kotsakiss study showed that younger age lower body weight longer first ICU stay and non-target time transfer 0600-1159 were among the factors affecting childrens ICU return Can these conditions and risk factors for PICU re-entry and ICU re-entry in adult liver transplant recipients be applied to analyze ICU re-entry in pediatric liver transplant recipients We dont know Because there is a significant physiological difference between adults and children liver transplantation is difficult to apply PICU reentry cause analysis due to the difficulty of operation and the uniqueness of immunosuppressive therapy In other words risk factors for postoperative ICU return in pediatric liver transplant recipients may differ from those in adult liver transplant recipients and other children Therefore a separate analysis of risk factors for unplanned ICU return after liver transplantation in children is necessary
There are significant differences in ICU re-entry rates among liver transplant recipients in different studies Young Gon Son et al reported that 58 68 patients 1181 patients of the enrolled patients underwent ICU re-entry after liver transplantation A case-control study at a Canadian medical center showed that 14 of 369 patients who received liver transplants at the center between 2005 and 2012 had ICU re-entry They had a longer first hospital stay P0001 and a lower cumulative survival rate of 1 month to 2 years P0001 The study by Mark et al showed that ICU re-entry occurred in 34 of 167 liver transplant recipients Several studies of risk factors for ICU return after liver transplantation have also shown mixed results For example Levy et al showed that older age and more intraoperative blood transfusion in liver transplant recipients were positively associated with ICU return Filipe et al showed that more than 20 breaths per minute at ICU discharge after liver transplantation was an independent risk factor for ICU return during the same hospitalization At present studies on ICU re-entry rate and risk factors after liver transplantation mostly focus on adult liver transplant recipients There are no reports on risk factors for ICU return after liver transplantation in children Some reports of PICUs return were found For example Angela S statistically analyzed 117923 children admitted to 73 PICUs from 2005 to 2008 The ICU re-entry rate was 37 of which 3814 occurred early ICU re-entry within 48 hours Patient characteristics strongly associated with an increased risk of early readmission included age 6 months acute respiratory and renal disease and underlying chronic conditions such as liver disease bone marrow transplantation and airway stenosis Afrothite Kotsakiss study showed that younger age lower body weight longer first ICU stay and non-target time transfer 0600-1159 were among the factors affecting childrens ICU return Can these conditions and risk factors for PICU re-entry and ICU re-entry in adult liver transplant recipients be applied to analyze ICU re-entry in pediatric liver transplant recipients We dont know Because there is a significant physiological difference between adults and children liver transplantation is difficult to apply PICU reentry cause analysis due to the difficulty of operation and the uniqueness of immunosuppressive therapy In other words risk factors for postoperative ICU return in pediatric liver transplant recipients may differ from those in adult liver transplant recipients and other children Therefore a separate analysis of risk factors for unplanned ICU return after liver transplantation in children is necessary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None