Dynamics of Immune Map and Outcomes After On-pump Cardiac Surgery: Protocol for a Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- West China Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- composite outcome
Study Overview
Brief Summary
Although systemic inflammatory response induced by cardiopulmonary bypass is believed as one of main reasons for these adverse events, the involved mechanism is still unclear.This cohort study would include patients undergoing on-pump valve surgery or CABG. By detecting the changes of immune cell expression profile and inflammatory related substances in blood, the spatiotemporal change curve of immune function of patients is drawn for avoiding or treating adverse events.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(1) participants aged over 18 years; (2) Participants who scheduled for valve replacement or valvuloplasty, coronary artery bypass under CPB.
Exclusion Criteria
- •(1) participant with a cognitive or mental disorder who is unable to sign an informed consent form; (2) suffering from basic immune system and blood system diseases; (3) pregnancy; (4) preoperative radiotherapy and chemotherapy; (5) receive immunosuppressive drugs within six months;(6) Expected survival time less than 2 years;(7) participated in other intervention clinical trials within 30 days before operation.
Outcomes
Primary Outcomes
composite outcome
Time Frame: From the beginning of surgery to 30 days after surgery or to discharge from hospital
the incidence of vital organ injury, which is defined as a composite measure, including postoperative death, vital organ dysfunction, and mechanical ventilation duration greater than 24 hours. And the vital organ dysfunction includes new kidney injury, long-term low cardiac output, severe liver function injury and neurological function injury.
Secondary Outcomes
- Infection(From the beginning of surgery to 30 days after surgery or to discharge from hospital])
- Acute lung injury(From the beginning of surgery to 30 days after surgery or to discharge from hospital])
- MACCE(From the beginning of surgery to 30 days after surgery or to discharge from hospital])
- Gastrointestinal complications(From the beginning of surgery to 30 days after surgery or to discharge from hospital)
Investigators
Lei Du
37#,Guoxue Road ,Chengdu, Sichuan Province, China
West China Hospital