On-pump Valve Surgery or CABGDIMOCSNCT05400356
Dynamics of Immune Map and Outcomes After On-pump Cardiac Surgery: Protocol for a Prospective Cohort Study
An observational study of On-pump Valve Surgery or CABG, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- On-pump Valve Surgery or CABG
- What is being tested?
- On-pump valve surgery or CABG
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- (1) participants aged over 18 years; (2) Participants who scheduled for valve replacement or valvuloplasty, coronary artery bypass under CPB.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Tingting doctor Wang, Doctor, 86-13606812800, wangtingting@163.com
About this study
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.
- Conditions
- On-pump Valve Surgery or CABG
- Being tested
- On-pump valve surgery or CABG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-pump valve surgery or CABGProcedure or surgery
On-pump valve surgery or coronary arterial bypass grafting
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: On-pump valve surgery or CABG | |
| 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. Receives: Procedure: On-pump valve surgery or CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the beginning of surgery to 30 days after surgery or to discharge from hospital
Secondary outcomes (4)
Infection
Measured: 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
Measured: 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
Measured: From the beginning of surgery to 30 days after surgery or to discharge from hospital]
Gastrointestinal complications
including gastrointestinal bleeding and intestinal ischemia
Measured: From the beginning of surgery to 30 days after surgery or to discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Jun 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for On-pump Valve Surgery or CABGStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Du, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400356
- Sponsor's protocol ID
- WCH
- Acronym
- DIMOCS
- Status last verified
- Feb 2023
- First submitted
- 27 May 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40270561
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamics of Immune Map and Outcomes After On-pump Cardiac Surgery: Protocol for a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05400356
- Acronym / sponsor ID
- DIMOCS / WCH
- Conditions
- On-pump Valve Surgery or CABG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complication group | – | Procedure: On-pump valve surgery or CABGPostoperative 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 | – | Procedure: On-pump valve surgery or CABGPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- (1) participants aged over 18 years; (2) Participants who scheduled for valve replacement or valvuloplasty, coronary artery bypass under CPB.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-pump valve surgery or CABGOn-pump valve surgery or coronary arterial bypass grafting | Procedure or surgery | Complication group, Non-complication group |
Primary outcome
composite outcome
Time frame: 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.
4 secondary outcomes
Infection
Time frame: From the beginning of surgery to 30 days after surgery or to discharge from hospital]
MACCE
Time frame: From the beginning of surgery to 30 days after surgery or to discharge from hospital]
Acute lung injury
Time frame: From the beginning of surgery to 30 days after surgery or to discharge from hospital]
Gastrointestinal complications
Time frame: From the beginning of surgery to 30 days after surgery or to discharge from hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Derived from this study: PubMed 40270561Zheng 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of On-pump Valve Surgery or CABG, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Lin, doctor (+86 18980605853, 350576038@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite outcome (time frame: From the beginning of surgery to 30 days after surgery or to discharge from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05400356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.