rSO2-LDLT: Intraoperative Cerebral and Renal Tissue Oxygen Saturation and Pediatric Living Donor Liver Transplantation Prognosis.

• Sponsor: RenJi Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04518332
• Collaborator: (none)
• Enrollment: 123
• Location: 1
• Anticipated Duration (Months): 52
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Liver Transplantation; Developmental Delay; Postoperative Complications; Socioemotional Delay

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 Design

• Study Type: Observational
• Anticipated Enrollment: 123 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: 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.
• Actual Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Outcome Measures

Primary Outcome Measures

1. Developmental delay [10days]

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

2. Developmental delay [1 month]

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

3. Developmental delay [3 months]

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

4. Developmental delay [6 months]

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

5. Developmental delay [1 year]

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

6. Developmental delay [2 years]

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

7. Developmental delay [3 years]

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

8. Socioemotional Delay [10days]

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

9. Socioemotional Delay [1 month]

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

10. Socioemotional Delay [3 months]

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

11. Socioemotional Delay [6 months]

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

12. Socioemotional Delay [1 year]

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

13. Socioemotional Delay [2 years]

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

14. Socioemotional Delay [3 years]

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

Secondary Outcome Measures

1. Postoperative complications [30 days]

   Postoperative complications including Cardiovascular system, respiratory system, digestive system, urinary system, blood system will be screened.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 36 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renji Hospital	Pudong	Shanghai	China	200127

Sponsors and Collaborators

• RenJi Hospital

Investigators

• Study Director: Weifen Yu, MD,PhD, Renji Hospital, School of Medicine, Shanghai Jiaotong University, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: RenJi Hospital
• ClinicalTrials.gov Identifier: NCT04518332
• Other Study ID Numbers: 20200808
• First Posted: Aug 19, 2020
• Last Update Posted: Oct 4, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Postoperative Complications

Study Results

No Results Posted as of Oct 4, 2021