Intraoperative Cerebral and Renal Tissue Oxygen Saturation and Pediatric Living Donor Liver Transplantation Prognosis.

Postoperative Complications Clinical Trial

— rSO2-LDLT  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04518332
• Other study ID #: 20200808
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2021
• Source: RenJi Hospital
• Contact: Dan Huang, M.S.
• Phone: +86 15921108822
• Email: huangdan363[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 123
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Developmental Delay
• Pediatric Liver Transplantation
• Postoperative Complications
• Socioemotional Delay

Locations

Country	Name	City	State
China	Renji Hospital	Pudong	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Developmental delay	Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.	10days
Primary	Developmental delay	Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.	1 month
Primary	Developmental delay	Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.	3 months
Primary	Developmental delay	Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.	6 months
Primary	Developmental delay	Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.	1 year
Primary	Developmental delay	Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.	2 years
Primary	Developmental delay	Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.	3 years
Primary	Socioemotional Delay	Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.	10days
Primary	Socioemotional Delay	Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.	1 month
Primary	Socioemotional Delay	Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.	3 months
Primary	Socioemotional Delay	Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.	6 months
Primary	Socioemotional Delay	Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.	1 year
Primary	Socioemotional Delay	Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.	2 years
Primary	Socioemotional Delay	Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.	3 years
Secondary	Postoperative complications	Postoperative complications including Cardiovascular system, respiratory system, digestive system, urinary system, blood system will be screened.	30 days