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

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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04518332

Acronym

rSO2-LDLT

Enrollment

123

Registered

2020-08-19

Start date

2020-09-01

Completion date

2024-12-31

Last updated

2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 36 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Developmental delay	10days	Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.
Socioemotional Delay	10days	Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.

Secondary

Measure	Time frame	Description
Postoperative complications	30 days	Postoperative complications including Cardiovascular system, respiratory system, digestive system, urinary system, blood system will be screened.

Countries

China

Contacts

Primary ContactDan Huang, M.S.

huangdan363@163.com+86 15921108822

Outcome results