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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05400356
Acronym
DIMOCS
Enrollment
120
Registered
2022-06-01
Start date
2022-06-01
Completion date
2023-03-31
Last updated
2023-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

On-pump Valve Surgery or CABG

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.

Interventions

PROCEDUREOn-pump valve surgery or CABG

On-pump valve surgery or coronary arterial bypass grafting

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
composite outcomeFrom the beginning of surgery to 30 days after surgery or to discharge from hospitalthe 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

MeasureTime frameDescription
InfectionFrom the beginning of surgery to 30 days after surgery or to discharge from hospital]
MACCEFrom the beginning of surgery to 30 days after surgery or to discharge from hospital]including all-cause mortality, myocardial infarction, severe arrhythmias and stroke
Acute lung injuryFrom 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
Gastrointestinal complicationsFrom the beginning of surgery to 30 days after surgery or to discharge from hospitalincluding gastrointestinal bleeding and intestinal ischemia

Countries

China

Contacts

Primary ContactJing Lin, doctor
350576038@qq.com+86 18980605853
Backup ContactTingting Wang, doctor
wangtingting2045@163.com+8613606812800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026