Clinical trial NCT04945915: Prediction of PPC Using DAMPs in Adult Cardiac Surgery
Official title: Prediction of Postoperative Pulmonary Complications Using Damage-associated Molecular Patterns in Adult Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiopulmonary Bypass
Cardiac Surgery
Damage-associated Molecular Patterns
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgery using cardiopulmonary bypass (CPB)

Brief summary: DAMPs (damage associated molecular patterns) are endogenous molecules that are expressed by cell stress or cell damage and play an important role in tissue (or host) defense and repair by activating the innate immune system. This is not the case with infections or injuries. Briefly, it starts when the immune system is activated by a receptor that recognizes a damage pattern, and it is a generic term for continuous responses by endogenous molecules expressed in this process. Recently, immuno-cancer drugs for cancer treatment by applying this immune response are also emerging. In cardiac surgery using cardiopulmonary bypass (CPB), there are more deleterious effects and adverse effects caused by using CPB than the surgery itself. There are several studies that have revealed the association between DAMPs and the degree of complications by approaching them from the point of view of tissue damage caused by the use of CPB. Therefore, we intend to investigate the 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Concentration of heparan sulfate (HS)
timeFrame: the day after surgery, up to 48hours
measure: Concentration of high mobility group box 1 (HMGB1)
timeFrame: the day after surgery, up to 48hours
Secondary outcomes:
measure: Postoperative complication
timeFrame: during admission, up to 22 days
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Hee Young Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: