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

NCT05871203 | Unknown

• 1 other identifier: 2023-0359
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Kidney Injury

Keywords

Acute kidney injury; Cardiopulmonary bypass; gene expression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Postoperative acute kidney injury

Other: Gene sequencing

Postoperative non-acute kidney injury

Other: Gene sequencing

Interventions

Gene sequencing OTHER

Participants were taken blood samples for gene sequencing at three time periods: before, after, and 24 hours after the end of the surgery

Postoperative acute kidney injury; Postoperative non-acute kidney injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective major cardiac surgery under cardiopulmonary bypass

You may qualify if:

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

You may not qualify if:

• \) 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:
• Incomplete surgery;
• Secondary transfer in the operating room;
• Automatically request to terminate the test.

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Base Sequence

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 23, 2023
• Study Start: May 17, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 10, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)