1. To get new insights in the pathophysiology of PPS by comparing tissue characteristics (histology) of the pericardium in patients with and without PPS. 2. To identify biomarkers that are associated with PPS by collecting 4 blood- and 1 pericardial…
ID
Source
Brief title
Condition
- Pericardial disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The following histology studies of pericardial tissue in patients with and
without PPS will be performed:
- Hematoxylin and eosin staining (HE stain)
- CD3, CD20 and CD68 staining (to identify macrophages, T- and B-lymphocytes)
- General description of findings by the pathologist.
2. Diagnosing PPS
Secondary outcome
To assess biomarkers that are associated with PPS by collecting 4 blood- and 1
pericardial fluid samples. The material will be stored in the central biobank
of the UMC Utrecht, because at this time it is unclear which biomarkers should
be investigated. This also depends partially on findings at histology studies.
Background summary
Post Pericardiotomy Syndrome (PPS) is a common complication of cardiac surgery
(10-20%) and is characterized by postoperative pericardial and pleural
effusions. The syndrome is associated with serious postoperative problems such
as cardiac tamponade. Inflammation is a possible etiologic factor, however the
exact pathogenesis and thus optimal treatment and prevention strategies, remain
unclear. Histology studies of PPS have never been performed before and may
provide new information about the pathophysiology of PPS.
Study objective
1. To get new insights in the pathophysiology of PPS by comparing tissue
characteristics (histology) of the pericardium in patients with and without
PPS.
2. To identify biomarkers that are associated with PPS by collecting 4 blood-
and 1 pericardial fluid sample in all study patients (ca. 40 patients). The
material will be stored in the central biobank of the UMC Utrecht, because at
this time it is unclear which biomarkers should be investigated. This also
depends partially on findings at histology studies.
3. To get new insights in changes in tissue characteristics after cardiac
surgery by comparing tissue characteristics of the pericardium in patients
undergoing initial cardiac surgery and in patients undergoing a rethoracotomy.
Study design
This study is designed as a case-control study. In all adult (*18 years)
patients undergoing a full resternotomy for any reason (24 hours after initial
surgery, but within 90 days after initial cardiac surgery), a small tissue
sample of the pericardium, a peripheral blood sample and a pericardial fluid
sample will be obtained. In case of a subxiphoid or lateral rethoracotomy, it
is not possible to obtain a pericardial tissue sample, therefore only a blood-
and pericardial fluid sample will be obtained in this category of patients.
We will retrospectively examine whether the patients who underwent a
resternotomy had PPS before the resternotomy or not by examining all the
perioperative echocardiograms, chest X-rays and medical records. This will be
done by two independent investigators. Pericardial tissue characteristics of
the two groups (PPS vs. no PPS) will be analyzed by an investigator who is
blinded for the diagnosis PPS to minimize the chance of observer bias.
Furthermore, in 10 adult patients undergoing isolated valve surgery (5
patients) or isolated CABG (5 patients) for the first time, peripheral blood, a
pericardial tissue sample and pericardial fluid will be obtained. The patients
will be followed during the postoperative phase (until discharge) to determine
whether they develop PPS or not. Also a second pericardial fluid sample will be
taken on day 3 postoperatively from the pericardial drain (or, if earlier,
directly before the drain is removed). Tissue characteristics will be compared
between the groups (PPS vs. no PPS). All pericardial fluid and blood that is
obtained in the study, will be saved in the Central Biobank of the UMCU to
investigate biomarkers that are associated with PPS in the future.
Study burden and risks
Because the pericardium is already opened by the surgeon in all the patients,
obtaining a small pericardial tissue sample is very unlikely to increase the
risk of the operation. Multiple studies showed that taking percutaneous
pericardial biopsies is safe. A sternotomy might be even safer because the fact
that the surgeon has the pericardium in sight. Also, in thoracic surgery, it is
daily practice to use parts of the pericardium to close operation defects. This
is considered safe by thoracic surgeons and is not known to be associated with
complications afterwards. The participants will not benefit directly from
participating in the study, but it might help the group (patients at risk of
PPS) in the future.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54644.041.16 |