- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04945915
Prediction of PPC Using DAMPs in Adult Cardiac Surgery
Prediction of Postoperative Pulmonary Complications Using Damage-associated Molecular Patterns in Adult Cardiac Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
DAMPs (damage-associated molecular patterns) are endogenous molecules expressed as a result of cell stress or damage. They play a crucial role in tissue or host defense and repair by activating the innate immune system. This differs from cases of infections or injuries. In a nutshell, the process begins when the immune system is triggered by a receptor that recognizes a damage pattern. DAMPs is a broad term encompassing continuous responses by endogenous molecules expressed during this process. More recently, there has been a growing focus on using this immune response for cancer treatment through immuno-cancer drugs. In cardiac surgery using cardiopulmonary bypass (CPB), various types of damage occur, including intravascular cannulation, exposure to the surface of the bypass circuit, ischemia-reperfusion injury, and surgical injury (operative trauma). During this process, the expression of pro-inflammatory cytokines and DAMPs (damage-associated molecular patterns) takes place. This leads to a response similar to sterile systemic inflammatory response syndrome (SIRS). As a result of this process, patients become more vulnerable to post-surgery infections or remote organ failure due to immune suppression.
Several studies have explored the link between DAMPs and the extent of complications by assessing tissue damage resulting from CPB usage. However, there is no study on the relationship between the occurrence of pulmonary complications and DAMPs in cardiac surgery, and therefore the authors aimed to determine changes in DMAPs over time during, and after cardiac surgery and the differences in DAMPs according to the presence or absence of postoperative pulmonary complications.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Yangsan, Korea, Republic of
- Pusan National University Yangsan Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients over 20 years of age
- Patients undergoing cardiac surgery using cardiopulmonary bypass (CPB)
Exclusion Criteria:
- pregnant women and minors
- the patients who required mechanical life support as follows due to unstable vital signs after CPB weaning, ECMO (extracorporeal membrane oxygenation) IABP (intra-aortic balloon pump)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of heparan sulfate (HS)
Time Frame: the day after surgery, up to 48hours
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blood sampling before CPB application, 90 minutes after CPB application, after CPB weaning, the day after surgery
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the day after surgery, up to 48hours
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Concentration of high mobility group box 1 (HMGB1)
Time Frame: the day after surgery, up to 48hours
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blood sampling before CPB application, 90 minutes after CPB application, after CPB weaning, the day after surgery
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the day after surgery, up to 48hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative complication
Time Frame: during admission, up to 22 days
|
By evaluating clinical recovery through the presence or absence of postoperative complications, the relationship between the concentration of DAMPs and the patient's clinical prognosis is investigated.
|
during admission, up to 22 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Hee Young Kim, MD, PhD, Pusan National University Yangsan Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 05-2018-139
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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