Postoperative ComplicationsNCT05529212
Cardiac Surgery and Postoperative Organ Dysfunction
An observational study of Postoperative Complications, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
The aim of the study is to identify the correlation between ischaemia reperfusion injury and postoperative multiorgan damage during cardiopulmonary cardiac surgery; and to investigate biomarkers that can predict postoperative organ damage in cardiac surgery. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- ischemic reperfusion injury
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2022to 30 Nov 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were screened from the outpatient clinics of the Second Hospital of the Army Medical University who were proposed for mitral valve replacement or mitral valve combined with aortic valve replacement, agreed to participate in this study, and signed an informed consent form.
Who may be able to join
- Age ≥50 years; patients requiring mitral valve replacement surgery or mitral valve plus aortic valve replacement under cardiopulmonary bypass
- Agreed to participate in this study, and signed the informed consent form.
Who cannot join
- History of neurological disease (stroke, reversible ischemic hypoxia, transient ischemic attack, or Neurodegeneration) ;
- Patients with severe preoperative renal insufficiency (serum creatinine > 442 μmol/L or need renal replacement therapy) ,
- liver dysfunction (Child-Pugh grade C)
- myocardial infarction within 4 weeks
- ASA grade ≥ V
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital of Chongqing medical university
Chongqing
About this study
Official title: Cardiopulmonary Bypass Ischemia/Reperfusion Injury and Postoperative Multiple Organ Dysfunction in Elder Patients
The aim of the study is to identify the correlation between ischaemia reperfusion injury and postoperative multiorgan damage during cardiopulmonary cardiac surgery; and to investigate biomarkers that can predict postoperative organ damage in cardiac surgery.
Read the detailed description
This study proposes to observe multi-organ functional impairment of the heart, kidney and brain after extracorporeal circulation in a prospective study of clinical patients; to obtain markers with diagnostic and predictive efficacy by collecting pre and postoperative serum and heart and ear tissue samples from patients with postoperative organ functional impairment, performing combined proteomic and metabolomic analyses, and by analysing them with detailed postoperative clinical prognostic data using machine learning algorithms.
- Conditions
- Postoperative Complications
- Being tested
- ischemic reperfusion injury
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ischemic reperfusion injuryProcedure or surgery
ischemic reperfusion injury is a pathological process in which the ischemic myocardium is restored to normal perfusion, but the tissue damage is progressively aggravated when the coronary artery supply is completely blocked after cardiopulmonary bypass surgery and then recanalised at a certain time.
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative cardiac injury
troponin I will be tested before and after surgery
Measured: from the ending of surgery to 7 days after surgery
incidence of postoperative acute kidney injury
renal function will be tested before and after surgery
Measured: from the ending of surgery to 7 days after surgery
incidence of postoperative brain injury
deliriumwill be tested before and after surgery
Measured: from the ending of surgery to 7 days after surgery
Secondary outcomes (1)
Incidence of postoperative arrhythmia events
postoperative arrhythmia events are recorded according to follow-up visits after surgery
Measured: from the ending of surgery to 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start16 Sep 2022 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Third Military Medical University
- Responsible party
- Sponsor
- Investigators
- He Huang, MD, Principal investigator, Chongqing Medical University, the second affiliated hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529212
- Sponsor's protocol ID
- Organ Dysfunction during CPB
- Status last verified
- Sep 2022
- First submitted
- 30 Aug 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data for this study is available from the sponsor on reasonable request through email.
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Bypass Ischemia/Reperfusion Injury and Postoperative Multiple Organ Dysfunction in Elder Patients
- ClinicalTrials.gov ID
- NCT05529212
- Acronym / sponsor ID
- Organ Dysfunction during CPB
- Conditions
- Postoperative Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Third Military Medical University
- Study start
- 16 Sep 2022 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 6 Sep 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.
The aim of the study is to identify the correlation between ischaemia reperfusion injury and postoperative multiorgan damage during cardiopulmonary cardiac surgery; and to investigate biomarkers that can predict postoperative organ damage in cardiac surgery.
Detailed description
This study proposes to observe multi-organ functional impairment of the heart, kidney and brain after extracorporeal circulation in a prospective study of clinical patients; to obtain markers with diagnostic and predictive efficacy by collecting pre and postoperative serum and heart and ear tissue samples from patients with postoperative organ functional impairment, performing combined proteomic and metabolomic analyses, and by analysing them with detailed postoperative clinical prognostic data using machine learning algorithms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were screened from the outpatient clinics of the Second Hospital of the Army Medical University who were proposed for mitral valve replacement or mitral valve combined with aortic valve replacement, agreed to participate in this study, and signed an informed consent form.
Key inclusion criteria (2 listed)
- Age ≥50 years; patients requiring mitral valve replacement surgery or mitral valve plus aortic valve replacement under cardiopulmonary bypass
- Agreed to participate in this study, and signed the informed consent form.
Key exclusion criteria (5 listed)
- History of neurological disease (stroke, reversible ischemic hypoxia, transient ischemic attack, or Neurodegeneration) ;
- Patients with severe preoperative renal insufficiency (serum creatinine > 442 μmol/L or need renal replacement therapy) ,
- liver dysfunction (Child-Pugh grade C)
- myocardial infarction within 4 weeks
- ASA grade ≥ V
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 |
|---|---|---|
| ischemic reperfusion injuryischemic reperfusion injury is a pathological process in which the ischemic myocardium is restored to normal perfusion, but the tissue damage is progressively aggravated when the coronary artery supply is completely blocked after cardiopulmonary bypass surgery and then recanalised at a certain time. | Procedure or surgery | – |
Primary outcome
incidence of postoperative cardiac injury
Time frame: from the ending of surgery to 7 days after surgery
troponin I will be tested before and after surgery
incidence of postoperative acute kidney injury
Time frame: from the ending of surgery to 7 days after surgery
renal function will be tested before and after surgery
incidence of postoperative brain injury
Time frame: from the ending of surgery to 7 days after surgery
deliriumwill be tested before and after surgery
1 secondary outcome
Incidence of postoperative arrhythmia events
Time frame: from the ending of surgery to 72 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Individual participant dataSharing planned: Yes. The individual participant data for this study is available from the sponsor on reasonable request through email.
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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.
He Huang, MD principal investigator
Chongqing Medical University, the second affiliated hospital
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 Postoperative Complications, run by The Second Affiliated Hospital of Chongqing Medical University 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 2 inclusion and 5 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 6 Sep 2022. 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 Qiao Guo, MD (13637870013, guoqiao@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative cardiac injury (time frame: from the ending of surgery to 7 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2022; AzTrials last refreshed its copy on 30 Oct 2026.