Evaluating Inflammatory Responses After Thoracic Aortic Surgery
Differential Diagnosis of Sterile Systemic Inflammation and Sepsis in Patients Undergoing Thoracic Aortic Surgery
This study is trying to see if blood tests can help doctors tell the difference between normal inflammation and infections in patients after they have open heart surgery on the aorta.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital Hradec Kralove Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Hradec Králové, Královehradecký Kraj) |
| Trial ID | NCT06028789 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the immunological responses that occur after open thoracic aortic surgery, focusing on differentiating between sterile systemic inflammation and infection. Patients scheduled for this surgery will provide blood samples before and after the procedure for a range of immunological tests. A control group will consist of patients with active infective endocarditis to compare biomarker dynamics. The study seeks to identify potential biomarkers that could help clinicians distinguish between postoperative inflammation and actual infections, thereby improving patient management.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for elective thoracic aortic replacement surgery.
Not a fit: Patients with active endocarditis or other infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and better management of postoperative complications in patients undergoing thoracic aortic surgery.
How similar studies have performed: While similar studies have explored inflammatory responses in surgical settings, this specific approach to differentiate between sterile inflammation and infection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (for study group): * patient scheduled for elective replacement of thoracic aorta of any extent by artificial vascular graft, including Bentall procedure, Yacoub procedure, supracoronary aortic replacement, also Ross procedure with supracoronary aortic replacement, hemiarch and total aortic arch replacement * signature of informed patient consent Exclusion Criteria (for study group): * active endocarditis or other infection * unstable preoperative condition Inclusion Criteria (for control group): * patient with active infectious endocarditis * signature of informed patient consent Exclusion Criteria (for control group): * more than 5 days since diagnosis
Where this trial is running
Hradec Králové, Královehradecký Kraj
- University Hospital Hradec Králové — Hradec Králové, Královehradecký Kraj, Czechia (Recruiting)
Study contacts
- Study coordinator: Jan Gofus, MD, PhD
- Email: jan.gofus@gmail.com
- Phone: +420 722 301 527
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.