Intraoperative Cerebral and Renal Tissue Oxygen Saturation and Pediatric Living Donor Liver Transplantation Prognosis. (rSO2-LDLT)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Developmental Delay; Pediatric Liver Transplantation; Socioemotional Delay

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.

• Study Type: Observational
• Enrollment (Anticipated): 123

Contacts and Locations

• Study Contact: Name: Dan Huang, M.S.; Phone Number: +86 15921108822; Email: huangdan363@163.com

Study Locations

• China
  • Shanghai
    • Pudong, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital
      • Contact: Dan Huang; Phone Number: 15921108822; Email: huangdan@renji.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Developmental delay	Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.	10days
Developmental delay	Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.	1 month
Developmental delay	Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.	3 months
Developmental delay	Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.	6 months
Developmental delay	Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.	1 year
Developmental delay	Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.	2 years
Developmental delay	Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.	3 years
Socioemotional Delay	Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.	10days
Socioemotional Delay	Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.	1 month
Socioemotional Delay	Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.	3 months
Socioemotional Delay	Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.	6 months
Socioemotional Delay	Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.	1 year
Socioemotional Delay	Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.	2 years
Socioemotional Delay	Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Postoperative complications including Cardiovascular system, respiratory system, digestive system, urinary system, blood system will be screened.	30 days

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Director: Weifen Yu, MD,PhD, Renji Hospital, School of Medicine, Shanghai Jiaotong University, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: August 16, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (ACTUAL): August 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 26, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 20200808

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No