Prediction of PPC Using DAMPs in Adult Cardiac Surgery

October 14, 2023 updated by: Kim Hee Young, Pusan National University Yangsan Hospital

Prediction of Postoperative Pulmonary Complications Using Damage-associated Molecular Patterns in Adult Cardiac Surgery

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.

Study Overview

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

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Yangsan, Korea, Republic of
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing cardiac surgery using cardiopulmonary bypass (CPB)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
blood sampling before CPB application, 90 minutes after CPB application, after CPB weaning, the day after surgery
the day after surgery, up to 48hours
Concentration of high mobility group box 1 (HMGB1)
Time Frame: the day after surgery, up to 48hours
blood sampling before CPB application, 90 minutes after CPB application, after CPB weaning, the day after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hee Young Kim, MD, PhD, Pusan National University Yangsan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2018

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 14, 2023

Last Verified

October 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

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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