Immune Heterogeneity Before and After Cardiopulmonary Bypass in Children

Ventricular Septal Defect Clinical Trial

Official title:

A Study of Immune Heterogeneity Before and After Cardiopulmonary Bypass in Children Undergoing Cardiac Surgery Based on scRNA-seq

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06214182
• Other study ID #: 2023-IRB-0303-P-01
• Status: Enrolling by invitation
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: The Children's Hospital of Zhejiang University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of this observational study is to learn about functional heterogeneity of immune cells before and after cardiopulmonary bypass (CPB) in children with congenital heart disease (CHD). The main question[s] it aims to answer are:

• Does CPB cause immune paralysis after CHD surgery?

• How does the functional heterogeneity of immune cells change before and after CPB in children undergoing CHD surgery? Participants will receive 3ml of peripheral blood before CPB, 2 hours after CPB, and 3 days after CPB, and the peripheral blood samples will be sequenced by single cell to explore the immune heterogeneity before and after CPB.

Description:

CPB-induced immune paralysis is the main cause of postoperative infection in CHD, which seriously affects the prognosis of children. The underlying mechanism of CPB-induced immune paralysis has not been fully determined. This study intends to use scRNA-seq to describe gene transcription profiles of immune cells in peripheral blood of children undergoing CHD surgery before and after CPB, and explore the differences within and between different immune cell populations including T cells and the changes of immune cells in different sequences. To fill the gap in the study of immune mechanism in CPB-induced immune paralysis microenvironment at single-cell resolution.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Days to 1 Year

Eligibility

Inclusion Criteria:

1. Birth weight range: 2500-4000g;

2. Operation duration >90min;

Exclusion Criteria:

1. preterm infants or preoperative infections;

2. systemic immune diseases and serious complications: such as rheumatoid arthritis, systemic lupus erythematosus, severe liver and kidney function damage, leukemia, etc.;

3. Patients who have received an organ transplant;

4. Patients who have received immunomodulatory drugs: patients who have received immunomodulatory drugs before surgery;

5. Parents refused to participate or were unable to provide sufficient samples: Parents or legal guardians refused to participate in the study.

Related Conditions & MeSH terms

• Heart Septal Defects, Ventricular
• Ventricular Septal Defect

Locations

Country	Name	City	State
China	Children's Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Children's Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of genes	The gene expression in single cells of peripheral blood samples was detected	From enrollment to the end of CPB at 3 days