Pericardial Tissue and the Post Pericardiotomy Syndrome

Completed

Conditions: postpericardial injury syndrome
Dressler syndrome
10034468
10007593

Registration Number: NL-OMON44142

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1) For rethoracotomy patients:
- Adult (*18 years) patients undergoing a rethoracotomy for any reason, within 90 days after initial cardiac surgery.;2) For patients undergoing a first sternotomy:
- Adult (*18 years) patients undergoing an isolated CABG (5 patients) or isolated valve surgery (5 patients) via a full sternotomy for the first time.

Exclusion Criteria

1) For patients undergoing a rethoracotomy:
- Patients undergoing a rethoracotomy within 24 hours after initial cardiac sugery (24 hours after the first incision)
- Patients undergoing pericardial surgery (pericardial window or pericardiectomy) as initial surgery because of recurrent pericardial fluid or a pericardial disease.
- Patients undergoing a heart transplantation as initial surgery (because of the routine use of anti-inflammatory agents postoperatively)
- Patients undergoing a LVAD implantation as initial surgery
- Patients undergoing valve replacement as initial surgery because of endocarditis
- Patients with a medical history of pericarditis
- Patients with a medical history of auto-immune disease and who use corticosteroids on a daily basis;2) For patients undergoing a first sternotomy:
- Patients undergoing an emergency operation
- Patients with a medical history of pericarditis
- Patients with a medical history of auto-immune disease and who use corticosteroids on a daily basis
- Patients with endocarditis
- Patients with pericardial effusion on the preoperative echo.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. The following histology studies of pericardial tissue in patients with and<br /><br>without PPS will be performed:<br /><br>- Hematoxylin and eosin staining (HE stain)<br /><br>- CD3, CD20 and CD68 staining (to identify macrophages, T- and B-lymphocytes)<br /><br>- General description of findings by the pathologist.<br /><br><br /><br>2. Diagnosing PPS</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess biomarkers that are associated with PPS by collecting 4 blood- and 1<br /><br>pericardial fluid samples. The material will be stored in the central biobank<br /><br>of the UMC Utrecht, because at this time it is unclear which biomarkers should<br /><br>be investigated. This also depends partially on findings at histology studies. </p><br>