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临床试验/NCT04518332
NCT04518332招募中不适用

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.

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
123
试验地点
1
主要终点
Developmental delay

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
6 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Developmental delay

时间窗: 3 years

Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.

Socioemotional Delay

时间窗: 3 years

Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.

次要结局

  • Postoperative complications(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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