Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06162260 |
| Other study ID # |
gaoleiqing |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2023 |
| Est. completion date |
December 28, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
RenJi Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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 6.1%. The average length of stay of the re-entry
patients was 2.5 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 5.8% (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 (P<0.001) and a lower cumulative survival rate of 1 month to 2 years (P<0.001).
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 PICU's
return were found. For example, Angela S statistically analyzed 117,923 children admitted to
73 PICUs from 2005 to 2008. The ICU re-entry rate was 3.7%, of which 38%(1.4%) 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 Kotsakis's study showed that younger age, lower body weight, longer first
ICU stay, and non-target time transfer (06:00-11:59) were among the factors affecting
children's 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 don't 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.
