We want to describe in detail the MTH-induced changes in pro- and anti-inflammatory markers in patients after CA. We further aim to evaluate the relation between neurological outcome and levels of pro- and anti-inflammatory markers.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Determine whether minor variations in the expression of systemic pro- and
anti-inflammatory markers in post-CA patients during treatment with hypothermia
result in better neurological outcome compared to patients showing large
variations.
Secondary outcome
- Does the expression of pro- and anti-inflammatory markers relate to
mechanical ventilation days, length of stay at the ICU and survival of the
patients?
- Is there an association between the expression of pro- and anti-inflammatory
markers and speed of cooling and re-warming?
- Is there an association between the expression of pro- and anti-inflammatory
markers and temperature stability during the maintenance phase of MTH?
- Is there a relation between hypoperfusion (measured with NIRS) and markers of
inflammation before, during and after induction of MTH in post-CA patients
Background summary
Mild therapeutic hypothermia (MTH) has been shown to improve survival and
neurological outcome in patients successfully resuscitated after cardiac arrest
(CA). While MTH is standard therapy worldwide, there is no proof of the optimal
timing and speed of cooling and re-warming. The mechanisms underlying the
beneficial effects of MTH are multiple and can affect various steps in the
cascade of ischemia and reperfusion. In post-CA resuscitated patients an early
systemic inflammatory response emerges, characterized by increased markers of
inflammation, which may last hours to several days. Animal models for brain
ischemia and cell culture experiments have shown that hypothermia decreases the
production of inflammatory cytokines. Furthermore, in a small study of ten
post-CA patients hypothermia seems to shift the inflammatory balance mainly
during the re-warming phase. Hypothermia induced effects on the inflammatory
balance in post-CA patients are still largely unknown. Therefore, in this study
we aim to observe how MTH modulates the systemic inflammatory response after CA
and whether it relates to patient*s outcome and longitudinal measurements of
tissue perfusion.
Study objective
We want to describe in detail the MTH-induced changes in pro- and
anti-inflammatory markers in patients after CA. We further aim to evaluate the
relation between neurological outcome and levels of pro- and anti-inflammatory
markers.
Study design
Prospective observational single centre study at the ICU.
Study burden and risks
This study is observational and does not carry additional risks for the
included patients. Blood sampling will be done from an existing intra-arterial
catheter, which is present as standard care in all cardiac arrest patients
admitted to the ICU, and will not exceed 5 times 9.5ml (total: 47.5ml). The
non-invasive cerebral tissue hemoglobin oxygenation measurements are performed
with a probe that is integrated in a forehead patch. These measurements are
already performed during cardiothoracic procedures in order to monitor cerebral
tissue perfusion, and do not add up to patient discomfort.
De Boelelaan 1117
Amsterdam 1007 MB
NL
De Boelelaan 1117
Amsterdam 1007 MB
NL
Listed location countries
Age
Inclusion criteria
- age >=18 years
- post cardiac arrest with spontaneous return of circulation
- undergoing mild therapeutic hypothermia
- admittance to the intensive care
- written informed/deferred consent
Exclusion criteria
-pregnancy
-severe traumatic brain injury
-cardiac arrest due to submersion
-infection already present before collapse
-moribund patients
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 | NL39943.029.12 |