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

Recruiting

• Conditions: On-pump Valve Surgery or CABG
• Interventions: Procedure: On-pump valve surgery or CABG

• Registration Number: NCT05400356
• Lead Sponsor: West China Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-05-27
• Study Start: 2022-06-01
• Study First Posted: 2022-06-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-18
• Last Update Posted: 2023-02-22
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Complication group	On-pump valve surgery or CABG	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.
Non-complication group	On-pump valve surgery or CABG	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.

Primary Outcome Measures

Name	Time	Method
composite outcome	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 Outcome Measures

Name	Time	Method
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]	Acute onset of bilateral infiltrates on the chest readiograph and hypoxaema(PaO2/Fi O2 ratio \<300) in the absence of clincial evidence of left atrial hypertension
MACCE	From the beginning of surgery to 30 days after surgery or to discharge from hospital]	including all-cause mortality, myocardial infarction, severe arrhythmias and stroke
Gastrointestinal complications	From the beginning of surgery to 30 days after surgery or to discharge from hospital	including gastrointestinal bleeding and intestinal ischemia

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China