Immune Heterogeneity Before and After Cardiopulmonary Bypass in Children

January 19, 2024 updated by: Wenyuan Zhang, The Children's Hospital of Zhejiang University School of Medicine

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Children's Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

In this study, children aged 31d-1y who underwent subCPB ventricular septal defect repair for the first time between January 2024 and February 2024 at the Children's Hospital Affiliated to Zhejiang University School of Medicine were enrolled. This study will comply with the requirements set out in the Declaration of Helsinki and will be approved by the Ethics Committee of our Institute.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group T1
T1 is before CPB.
Group T2
T2 is 2 hours after CPB.
Group T3
T3 is 3 days after CPB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression of genes
Time Frame: From enrollment to the end of CPB at 3 days
The gene expression in single cells of peripheral blood samples was detected
From enrollment to the end of CPB at 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 19, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-IRB-0303-P-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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