To differentiate between gene expression in sepsis and sterile sirs.
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Helminthic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To differentiate between sepsis and sterile SIRS by means of gene expression.
Secondary outcome
Translate the genes that are expressed in sepsis into a protein which may be
used as a diagnostic test in the future.
To reduce the unnecessary use of antibiotics in patients after cardiac surgery
To prohibit the adverse effect of extensive use of antibiotics such as
bacterial resistance or developing superinfection as a result of
microbiological inbalance.
To reduce procedures which are a result of suspecting an infectious cause,
such as unnecessarily changing CVC*s
Background summary
Because of the high risk of infection and endocarditis in patients after
cardiac surgery,
there is a low threshold for starting antibiotics when infection is suspected,
or changing the CVC when catheter related infection is suspected.
Systemic Inflammatory Response Syndrome (SIRS) appears similar clinically,
irrespective if it is caused by an infectious (sepsis) or non-infectious
(sterile SIRS) etiology.
In pediatric patients after cardiac surgery there is a low threshold for the
use of antibiotics when infection is suspected. However, in a lot of cases no
causative microorganism can be demonstrated. Probably, the symptoms are
reflecting SIRS, which can for example, be the result of using cardiopulmonary
bypass during the procedure.
Often unnecessary antibiotics will be started. Extensive use of antibiotics
might cause adverse effects such as bacterial resistance and infections with
candida or aspergillus species.
Every seven days, the central venous catheter is electively changed, although
in literature there is no evidence found for this routine. In case of
suspected (blood stream) infection, often the CVC will be replaced, which can
lead to mechanical or other omplications, and also another vessel might be
sacrificed due to obstruction.
Despite the similar phenotypic expression, genotypic expression may differ in
case of different etiologies causing SIRS. This hypothesis is verified by
several studies in critical ill adults with all kinds of underlying diseases.
Besides the arguments mentioned above, differentiation between sepsis and
sterile SIRS is important considering the fact that the mortality of sepsis is
much higher than that of uninfected SIRS.
One study showed a unique pattern of gene expression in the neonatal myocardium
of neonates after cardiac surgery for right heart obstructive lesions. However
it*s not clear whether this is age dependent, or reflecting underlying
disease.
In several other publications (in adults), gene expression profiles after
cardiopulmonary bypass and cardioplegic arrest were described.
Study objective
To differentiate between gene expression in sepsis and sterile sirs.
Study design
This is an observational explorative study that will be conducted at the
operating room (OR) and pediatric intensive care unit (PICU) at LUMC, Leiden,
the Netherlands.
20 patients will be enrolled in the study, undergoing cardiac surgery with
bypass for congenital heart defects.
Residual blood from arterial samples will be collected on the OR ( moment of
study entry), immediate after admittance on the PICU, 12, 24 and 48 hours
later. Taking blood samples at these timepoints is routine patient practice.
Genetic expression will be analyzed, in order to investigate if there is a
differencein expression in patients with SIRS or Sepsis.
The diagnosis of Sepsis and SIRS are based on the clinical criteria as defined
by the Members of the International consensus conference on pediatric sepsis.
Study burden and risks
not applicable
albinusdreef 2
2300 RC Leiden
Nederland
albinusdreef 2
2300 RC Leiden
Nederland
Listed location countries
Age
Inclusion criteria
Pediatric patients who need surgery for congenital heartdefects, and will need cardiopulmonary bypass.
Exclusion criteria
steroid administration, participation in other crt
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 | NL19974.058.07 |