Prediction of PPC Using DAMPs in Adult Cardiac Surgery

NCT04945915 | Completed

• 1 other identifier: 05-2018-139
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiopulmonary Bypass; Cardiac Surgery; Damage-associated Molecular Patterns

Outcome Measures

Primary Outcomes (2)

• Concentration of heparan sulfate (HS)

  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)

  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 Outcomes (1)

• Postoperative complication

  during admission, up to 22 days

Interventions

blood sampling OTHER

There was no intervention because this reasearch is observational study.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardiac surgery using cardiopulmonary bypass (CPB)

You may qualify if:

• Adult patients over 20 years of age
• Patients undergoing cardiac surgery using cardiopulmonary bypass (CPB)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples were collected four times in total, and 7 ml of blood was collected after induction of anesthesia (T1), 90 minutes after CPB (T2), immediately after weaning from CPB (T3), and on the first day after surgery (T4). It was placed in a serum-separating tube and then centrifuged. Enzyme-linked immune sorbent assay is performed to measure the concentration of heparan sulfate (HS) and high mobility group box 1 (HMGB1) using HS ELISA kit (Finetest, EH4010) and HMGB1 ELISA kit (Solarbio, SEKH-0409), respectively. use.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Hee Young Kim, MD, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 30, 2021
• Study Start: August 6, 2018
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: October 17, 2023

Record last verified: 2023-10

Locations

KR (1)