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

Recruiting

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

• Registration Number: NCT04518332
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Study First Submitted: 2020-08-16
• Study First Submitted QC: 2020-08-18
• Study First Posted: 2020-08-19
• Study Start: 2020-09-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-26
• Last Update Posted: 2021-10-04
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 123

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Developmental delay	3 years	Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.
Socioemotional Delay	3 years	Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	30 days	Postoperative complications including Cardiovascular system, respiratory system, digestive system, urinary system, blood system will be screened.

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Pudong, Shanghai, China