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

NCT ID: NCT04518332

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Pediatric Liver Transplantation Developmental Delay Postoperative Complications Socioemotional Delay

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Weifen Yu, MD,PhD

Role: STUDY_DIRECTOR

Renji Hospital, School of Medicine, Shanghai Jiaotong University, China

Locations

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Renji Hospital

Pudong, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dan Huang, M.S.

Role: CONTACT

+86 15921108822

Facility Contacts

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Dan Huang

Role: primary

15921108822

Other Identifiers

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20200808

Identifier Type: -

Identifier Source: org_study_id

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