Dynamics of Immune Map and Outcomes After On-pump Cardiac Surgery: Protocol for a Prospective Cohort Study
DIMOCS
1 other identifier
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedFebruary 22, 2023
February 1, 2023
10 months
May 27, 2022
February 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Infection
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]
Acute lung injury
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
Study Arms (2)
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.
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.
Interventions
On-pump valve surgery or coronary arterial bypass grafting
Eligibility Criteria
Participants are recruited from West China Hospital of Sichuan University who would undergo cardiac surgery under CPB between June 2022 and December 2022
You may qualify if:
- (1) participants aged over 18 years; (2) Participants who scheduled for valve replacement or valvuloplasty, coronary artery bypass under CPB.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044, China
Related Publications (1)
Zheng Y, Ran Y, Wu J, Yang P, Liao X, Zhang J, Meng W, Gou D, Li L, Du L, Lin J. In vitro Validation of a Novel Disposable Remover to Remove Activated Leukocytes Generated During Cardiopulmonary Bypass: A Pilot Study. J Inflamm Res. 2025 Apr 18;18:5355-5370. doi: 10.2147/JIR.S503575. eCollection 2025.
PMID: 40270561DERIVED
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- 37#,Guoxue Road ,Chengdu, Sichuan Province, China
Study Record Dates
First Submitted
May 27, 2022
First Posted
June 1, 2022
Study Start
June 1, 2022
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
February 22, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share