Changes in Gene Expression and Prognosis of Blood Immune Cells After Cardiopulmonary Bypass Surgery
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05871203
Collaborator
(none)
12
1
1.8
6.8
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
12 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Changes in Gene Expression and Prognosis of Blood Immune Cells After Cardiopulmonary Bypass Surgery
Anticipated Study Start Date
:
May 17, 2023
Anticipated Primary Completion Date
:
Jun 30, 2023
Anticipated Study Completion Date
:
Jul 10, 2023
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Postoperative acute kidney injury [Within 48 hours after surgery]
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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
- Age≥ 18 years old; 2) Cardiopulmonary bypass descending valve replacement (molding), or coronary artery bypass grafting, or macrovascular surgery.
Exclusion Criteria:
-
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Second Affiliated Hospital of Zhejiang University anesthesiology department | Hangzhou | Zhejiang | China | 310000 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05871203
Other Study ID Numbers:
- 2023-0359
First Posted:
May 23, 2023
Last Update Posted:
May 23, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms: