Cardiopulmonary BypassNCT04945915
Prediction of PPC Using DAMPs in Adult Cardiac Surgery
An observational study of Cardiopulmonary Bypass and Cardiac Surgery, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiopulmonary Bypass, Cardiac Surgery, Damage-associated Molecular Patterns
- What is being tested?
- blood sampling
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Aug 2018to 30 Mar 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery using cardiopulmonary bypass (CPB)
Who may be able to join
- Adult patients over 20 years of age
- Patients undergoing cardiac surgery using cardiopulmonary bypass (CPB)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
There was no intervention because this reasearch is observational study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of heparan sulfate (HS)
blood sampling before CPB application, 90 minutes after CPB application, after CPB weaning, the day after surgery
Measured: the day after surgery, up to 48hours
Concentration of high mobility group box 1 (HMGB1)
blood sampling before CPB application, 90 minutes after CPB application, after CPB weaning, the day after surgery
Measured: the day after surgery, up to 48hours
Secondary outcomes (1)
Postoperative complication
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.
Measured: during admission, up to 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start6 Aug 2018
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Hee Young, Pusan National University Yangsan Hospital
- Investigators
- Hee Young Kim, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945915
- Sponsor's protocol ID
- 05-2018-139
- Status last verified
- Oct 2023
- First submitted
- 16 Jun 2021
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Postoperative Pulmonary Complications Using Damage-associated Molecular Patterns in Adult Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04945915
- Acronym / sponsor ID
- 05-2018-139
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 30 Jun 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery using cardiopulmonary bypass (CPB)
Key inclusion criteria (2 listed)
- Adult patients over 20 years of age
- Patients undergoing cardiac surgery using cardiopulmonary bypass (CPB)
Key exclusion criteria (2 listed)
- 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)
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 |
|---|---|---|
| blood samplingThere was no intervention because this reasearch is observational study. | Other | – |
Primary outcome
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
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
1 secondary outcome
Postoperative complication
Time frame: during admission, up to 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
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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.
Hee Young Kim, MD, PhD principal investigator
Pusan National University Yangsan 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 Cardiopulmonary Bypass and Cardiac Surgery, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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 2 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: finished, as of the sponsor's last update on 17 Oct 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of heparan sulfate (HS) (time frame: the day after surgery, up to 48hours). The study lists 2 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 17 Oct 2023.