Liver TransplantationNCT06162260
Unplanned ICU Readmission for Pediatric Liver Transplantation
An observational study of Liver Transplantation, run by RenJi Hospital.
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… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- ICU readmission
- Type of treatment
- Surgery or procedure
- How many people
- 1,575 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 28 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children who underwent liver transplantation at Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from Jan 1, 2018 to Dec 31, 2021.
Who may be able to join
- (1) Liver transplantation was performed from January, 2018 to December, 31, 2021.21;
- (2) Age < 18 years;
- (3) The patient was admitted to ICU for the first time due to postoperative monitoring after liver transplantation;
- (4) Survival on first transfer from ICU.
Who cannot join
- (1) Death during ICU stay after liver transplantation;
- (2) non-first-time recipients of liver transplantation;
- (3) Patients with complex conditions who were transferred to ICU for life support (such as mechanical ventilation, CRRT, etc.) before operation;
- (4) Patients admitted to ICU by appointment for surgical reasons.
- (5) Patients forcibly transferred from ICU.
About this study
Official title: Analyse Des Facteurs de Risque Pour la réintégration Non planifiée Post-opératoire de Patients transplantés du Foie Chez l'Enfant
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.
Read the 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 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.
- Conditions
- Liver Transplantation
- Being tested
- ICU readmission
- Keywords
- readdmission;ICU;transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU readmissionProcedure or surgery
Children who underwent liver transplantation at Renji Hospital, Shanghai Jiao Tong University School of Medicine from January 1, 2018 to December 31, 2021 and were transferred out of ICU for the first time during the same hospitalization cycle.
| Study group | Role | What they receive |
|---|---|---|
| observation group | (1) Liver transplantation was performed between January 1, 2019 and December 31, 2019; (2) Age < 18 years; (3) The patient was admitted to ICU for the first time due to postoperative monitoring after liver transplantation; (4) Survival on first transfer from ICU. Receives: Procedure: ICU readmission | |
| matched group | (1) Liver transplantation was performed between January 1, 2019 and December 31, 2019; (2) Age < 18 years; (3) The patient was admitted to ICU for the first time due to postoperative monitoring after liver transplantation; (4) survive the first transfer from ICU; (5) No ICU re-entry occurred in the same hospitalization period after liver transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned return to the ICU
ICU re-entry occurred within the same hospital cycle after the first ICU transfer after liver transplantation
Measured: 01/01/2018-31/12/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Dec 2023 (estimated)
- Primary completion29 Nov 2024 (estimated)
- Study completion28 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
- 1,575 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162260
- Sponsor's protocol ID
- gaoleiqing
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyse Des Facteurs de Risque Pour la réintégration Non planifiée Post-opératoire de Patients transplantés du Foie Chez l'Enfant
- ClinicalTrials.gov ID
- NCT06162260
- Acronym / sponsor ID
- gaoleiqing
- Conditions
- Liver Transplantation
- Keywords
- readdmission;ICU;transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,575 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 29 Nov 2024 (estimated)
- Study completion
- 28 Dec 2024 (estimated)
- First posted
- 8 Dec 2023 (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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observation group | – | Procedure: ICU readmission(1) Liver transplantation was performed between January 1, 2019 and December 31, 2019; (2) Age < 18 years; (3) The patient was admitted to ICU for the first time due to postoperative monitoring after liver transplantation; (4) Survival on first transfer from ICU. |
| matched group | – | –(1) Liver transplantation was performed between January 1, 2019 and December 31, 2019; (2) Age < 18 years; (3) The patient was admitted to ICU for the first time due to postoperative monitoring after liver transplantation; (4) survive the first transfer from ICU; (5) No ICU re-entry occurred in the same hospitalization period after liver transplantation. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children who underwent liver transplantation at Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from Jan 1, 2018 to Dec 31, 2021.
Key inclusion criteria (4 listed)
- (1) Liver transplantation was performed from January, 2018 to December, 31, 2021.21;
- (2) Age < 18 years;
- (3) The patient was admitted to ICU for the first time due to postoperative monitoring after liver transplantation;
- (4) Survival on first transfer from ICU.
Key exclusion criteria (5 listed)
- (1) Death during ICU stay after liver transplantation;
- (2) non-first-time recipients of liver transplantation;
- (3) Patients with complex conditions who were transferred to ICU for life support (such as mechanical ventilation, CRRT, etc.) before operation;
- (4) Patients admitted to ICU by appointment for surgical reasons.
- (5) Patients forcibly transferred from ICU.
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 |
|---|---|---|
| ICU readmissionChildren who underwent liver transplantation at Renji Hospital, Shanghai Jiao Tong University School of Medicine from January 1, 2018 to December 31, 2021 and were transferred out of ICU for the first time during the same hospitalization cycle. | Procedure or surgery | observation group |
Primary outcome
Unplanned return to the ICU
Time frame: 01/01/2018-31/12/2021
ICU re-entry occurred within the same hospital cycle after the first ICU transfer after liver transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by RenJi Hospital.
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 4 inclusion and 5 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 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned return to the ICU (time frame: 01/01/2018-31/12/2021). 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 8 Dec 2023.