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

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 Overview

• Status: Recruiting
• Conditions: On-pump Valve Surgery or CABG
• Intervention / Treatment: Procedure: On-pump valve surgery or CABG

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610044
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Tingting doctor Wang, Doctor; Phone Number: 86-13606812800; Email: wangtingting@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants are recruited from West China Hospital of Sichuan University who would undergo cardiac surgery under CPB between June 2022 and December 2022

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Complication group; 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.	Procedure: On-pump valve surgery or CABG; On-pump valve surgery or coronary arterial bypass grafting
Non-complication group; 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.	Procedure: On-pump valve surgery or CABG; On-pump valve surgery or coronary arterial bypass grafting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite outcome	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.	From the beginning of surgery to 30 days after surgery or to discharge from hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection		From the beginning of surgery to 30 days after surgery or to discharge from hospital]
MACCE	including all-cause mortality, myocardial infarction, severe arrhythmias and stroke	From the beginning of surgery to 30 days after surgery or to discharge from hospital]
Acute lung injury	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	From the beginning of surgery to 30 days after surgery or to discharge from hospital]
Gastrointestinal complications	including gastrointestinal bleeding and intestinal ischemia	From the beginning of surgery to 30 days after surgery or to discharge from hospital

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: WCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No