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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04518332
Other study ID # 20200808
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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