Dynamics of Immune Map and Outcomes After On-pump Cardiac Surgery: Protocol for a Prospective Cohort Study (DIMOCS)

Sichuan University

Status: Enrolling

Conditions: On-pump Valve Surgery or CABG

Treatments: Procedure: On-pump valve surgery or CABG

Study type: Observational

Funder types: Other

Identifiers

NCT05400356

WCH

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

Complication group

Description:

Postoperative complications are defined as postoperative death, vital organ dysfunction, and mechanical ventilation duration greater than 24 hours.The vital organ dysfunction includes new developed acute kidney injury, long-term low cardiac output, severe liver function injury and neurological function injury. The time of occurrence is defined as from the beginning of surgery to 30 days after surgery or to discharge from hospital.

Treatment:

Procedure: On-pump valve surgery or CABG

Non-complication group

Description:

Patients with none of postoperative complications which showed in Complication group. The time of occurrence is defined as from the beginning of surgery to 30 days after surgery or to discharge from hospital.

Treatment:

Procedure: On-pump valve surgery or CABG