Changes in Gene Expression and Prognosis of Blood Immune Cells After Cardiopulmonary Bypass Surgery

The goal of this observational study is to learn about the changes in gene expression in blood immune cells in after cardiac surgery with cardiopulmonary bypass.The main question it aims to answer is: What specific gene expression changes predict kidney damage after cardiac surgery with cardiopulmonary bypass. Participants received conventional treatment.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: Gene sequencing

• Study Type: Observational
• Enrollment (Anticipated): 12

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University anesthesiology department
      • Contact: Min Yan, Doctor; Phone Number: 18895386675; Email: zryanmin@zju.edu.cn
      • Principal Investigator: Min Yan, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective major cardiac surgery under cardiopulmonary bypass

Description

Inclusion Criteria:

• 1) Age≥ 18 years old; 2) Cardiopulmonary bypass descending valve replacement (molding), or coronary artery bypass grafting, or macrovascular surgery.

Exclusion Criteria:

• 1) any cognitive or mental impairment that is unable to sign the informed consent form; 2) Have basic immune system and blood system diseases; 3) pregnancy; 4) Receiving radiotherapy and chemotherapy before surgery; 5) Receiving immunosuppressive drugs within six months; 6) Have participated in other interventional clinical trials within 30 days before surgery.

Exit Criteria:

1. Incomplete surgery;
2. Secondary transfer in the operating room;
3. Automatically request to terminate the test.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Postoperative acute kidney injury	Other: Gene sequencing; Participants were taken blood samples for gene sequencing at three time periods: before, after, and 24 hours after the end of the surgery
Postoperative non-acute kidney injury	Other: Gene sequencing; Participants were taken blood samples for gene sequencing at three time periods: before, after, and 24 hours after the end of the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative acute kidney injury	SCr was elevated ≥ 26.5 micromol/L or 1.5 times the baseline for SCr ≥ or urine output < 0.5 mL/kg/hour within 6 hours within 48 hours	Within 48 hours after surgery

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 17, 2023
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): July 10, 2023

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Acute kidney injury; Cardiopulmonary bypass; gene expression
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury
• Other Study ID Numbers: 2023-0359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No