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

NCT ID: NCT05400356

Last Updated: 2023-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-03-31

Brief Summary

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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

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Conditions

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On-pump Valve Surgery or CABG

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

On-pump valve surgery or CABG

Intervention Type PROCEDURE

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.

On-pump valve surgery or CABG

Intervention Type PROCEDURE

On-pump valve surgery or coronary arterial bypass grafting

Interventions

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On-pump valve surgery or CABG

On-pump valve surgery or coronary arterial bypass grafting

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lei Du

37#,Guoxue Road ,Chengdu, Sichuan Province, China

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Lin, doctor

Role: CONTACT

+86 18980605853

Tingting Wang, doctor

Role: CONTACT

+8613606812800

Facility Contacts

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Tingting doctor Wang, Doctor

Role: primary

86-13606812800

References

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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.

Reference Type DERIVED
PMID: 40270561 (View on PubMed)

Other Identifiers

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WCH

Identifier Type: -

Identifier Source: org_study_id

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