Clinical trial NCT04518332: Intraoperative Cerebral and Renal Tissue Oxygen Saturation and Pediatric Living Donor Liver Transplantation Prognosis.
Official title: Association of Intraoperative Cerebral and Renal Tissue Oxygen Saturation With Developmental and Socioemotional Delay and Postoperative Complications After Living Donor Liver Transplantation for Children: an Observational Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Liver Transplantation
Developmental Delay
Postoperative Complications
Socioemotional Delay
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 123
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll patients aged from 6 to 36 months old who are scheduled for elective standard living-donor liver transplantation and have signed informed consent before the surgery.

Brief summary: This rSO2 study is a prospective clinical study. The purpose of the rSO2 study is to investigate whether there is a correlation between the intraoperative cerebral and renal tissue oxygen saturation and the incidence of developmental and socioemotional delay after living donor liver transplantation for children. This study will also investigate whether intraoperative cerebral and renal tissue oxygen saturation are related to postoperative complications.

Detailed description: There is high incidence of developmental and socioemotional delay and postoperative complications in pediatric living donor liver transplantation patients. In this prospective observational clinical study, the investigators aim to investigate the correlation between the intraoperative cerebral and renal tissue oxygen saturation and the incidence of developmental and socioemotional delay and postoperative complications. This study will enroll patients aged from 6 to 36 months old who are scheduled for elective standard living-donor liver transplantation and have signed informed consent before the surgery.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients (6 months\< the Moon's age \<36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital.

Exclusion Criteria:

* Forehead skin infection, A history of liver transplantation, Multivisceral transplantation, Refused to participate the study

Primary outcomes:
measure: Developmental delay
timeFrame: 10days
measure: Developmental delay
timeFrame: 1 month
measure: Developmental delay
timeFrame: 3 months
measure: Developmental delay
timeFrame: 6 months
measure: Developmental delay
timeFrame: 1 year
measure: Developmental delay
timeFrame: 2 years
measure: Developmental delay
timeFrame: 3 years
measure: Socioemotional Delay
timeFrame: 10days
measure: Socioemotional Delay
timeFrame: 1 month
measure: Socioemotional Delay
timeFrame: 3 months
measure: Socioemotional Delay
timeFrame: 6 months
measure: Socioemotional Delay
timeFrame: 1 year
measure: Socioemotional Delay
timeFrame: 2 years
measure: Socioemotional Delay
timeFrame: 3 years
Secondary outcomes:
measure: Postoperative complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Pudong
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University, China
name: Weifen Yu, MD,PhD
role: STUDY_DIRECTOR
References: