Determine whether and to what extent changes in microvascular perfused boundary region and syndecan-1 and heparan sulfate plasma levels, as measures for glycocalyx damage, occur in survivors and non-survivors of CA during the re-warming phase of…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Determine whether and to what extent changes in microvascular PBR, as measure
for glycocalyx damage, occur in survivors and non-survivors of CA during the
re-warming phase of therapeutic hypothermia treatment.
Secondary outcome
- Determine whether and to what extent changes in syndecan-1 and heparan
sulfate plasma levels, as measure for glycocalyx damage, occur in survivors and
non-survivors of CA during the re-warming phase of therapeutic hypothermia
treatment.
- Determine the association of syndecan-1 and heparan sulfate plasma levels
with the PBR in post-CA patients during the re-warming phase of therapeutic
hypothermia treatment.
- Determine whether and to what extent changes in microcirculatory perfused
vessel density (PVD) and mean flow index (MFI) occur in survivors and
non-survivors of CA during the re-warming phase of therapeutic hypothermia
treatment.
Background summary
Despite the appropriateness of mild therapeutic hypothermia to increase
survival and improve neurological outcome in patients after cardiac arrest
(CA), the mortality rate remains high in post-CA patients and full recovery in
survivors is still as low as 6-23%. The episode of CA with subsequent
cardiopulmonary resuscitation and return of spontaneous circulation represents
the process of global ischemia followed by reperfusion, which generates a
systemic inflammatory response. Besides other actions therapeutic hypothermia
limits this inflammatory response. However, after the period of therapeutic
hypothermia of 32-34oC the patient will be re-warmed to a normal body
temperature. A recent study showed in ten post-CA patients treated with mild
therapeutic hypothermia, a pro-inflammatory effect only during the re-warming
phase and not during the cooling phase. To what extent this inflammatory
response during the re-warming phase affects the microvasculature and changes
the integrity of the vascular wall is unknown. The endothelial glycocalyx has
been proved to be an important modulator of vascular permeability, coagulation,
leukocyte adhesion and inflammation, and functions as an endothelial barrier.
Glycocalyx function can be determined indirectly by measurement of components
of the glycocalyx (syndecan-1 and heparan sulfate) in plasma. With the recent
introduction of a novel technique for evaluation of sublingual microvascular
changes it has become possible to measure glycocalyx dimensions in patients.
This study investigates associations between biomarkers of glycocalyx damage
and mortality in post-CA patients during re-warming phase of therapeutic
hypothermia, hypothesizing that in non-survivors of CA glycocalyx damage will
be more pronounced during re-warming compared to survivors.
Study objective
Determine whether and to what extent changes in microvascular perfused boundary
region and syndecan-1 and heparan sulfate plasma levels, as measures for
glycocalyx damage, occur in survivors and non-survivors of CA during the
re-warming phase of therapeutic hypothermia treatment.
Study design
Prospective observational single center study at the ICU
Study burden and risks
This study is observational and does not carry additional risks or burden for
the included patients. Blood sampling will be done from an existing catheter
located in an artery, which is present as standard care in all post-CA patients
admitted to the ICU, and will not exceed 6 times 4.5ml (total: 27ml).
Sublingual measurement of the microcirculation is non-invasive and not longer
than 3 minutes per measurement. All patients treated with therapeutic
hypothermia at the ICU are sedated, therefore these measurements do not add up
to patient discomfort. There are no benefits from the present study for the
patient.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
* age *18 years
* out-of hospital cardiac arrest with spontaneous return of circulation
* undergoing mild therapeutic hypothermia
* admittance to the intensive care unit
* written informed/deferred consent
Exclusion criteria
* 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 | NL45946.029.13 |