Immune Heterogeneity Before and After Cardiopulmonary Bypass in Children

NCT ID: NCT06214182

Last Updated: 2025-03-11

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

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ventricular Septal Defect

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group T1

T1 is before CPB.

No interventions assigned to this group

Group T2

T2 is 2 hours after CPB.

No interventions assigned to this group

Group T3

T3 is 3 days after CPB.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Birth weight range: 2500-6000g;
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.
Minimum Eligible Age

31 Days

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Children's Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Wenyuan Zhang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2023-IRB-0303-P-01

Identifier Type: -

Identifier Source: org_study_id

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