The primary objective of this study is to identify in what manner micro- and macro hemodynamic parameters responds to critical illness and therapy, and to determine how this interaction is related to different states of organ dysfunction (heart,…
ID
Source
Brief title
Condition
- Other condition
- Heart failures
- Cardiac therapeutic procedures
Synonym
Health condition
circulatory shock and tissue hypoperfusion
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Standard Operating Procedure for measurement of Microcirculatory perfusion
(cutaneous / mucosal / sublingual tissues): vessel density parameters,
microvascular flow index, and flow heterogeneity.
Secondary outcome
not applicable
Background summary
Rationale: Assessment of the microcirculation is considered important adjunct
measurements to conventional systemic hemodynamic monitoring, such as arterial
blood pressure, heart rate, cardiac output and its determinants.
Microcirculation assessment is possible using sidestream dark field imaging.
However, its use has several limitations that have hampered the introduction of
this mode of hemodynamic diagnosis into routine clinical practice. A new
technologically advanced version of hand held microscopes (CytoCam, Braedius
Medical, Naarden the Netherlands) based on Incident Dark Field (IDF) imaging
with improved ease and speed of measurement and higher optical resolution has
been recently introduced allowing more vessels to be observed with larger
detail. The device is based on a computer controlled large resolution imaging
sensor and allows instant quantification of images to provide the needed
microcirculatory parameters directly at the bedside. This advance now offers
the opportunity of introducing the clinical evaluation of the microcirculation
into routine clinical use at the bedside, allowing sequential measurements to
follow for the first time the evolution of microcirculatory alterations in
disease and therapy.
Study objective
The primary objective of this study is to identify in what manner micro- and
macro hemodynamic parameters responds to critical illness and therapy, and to
determine how this interaction is related to different states of organ
dysfunction (heart, kidney and lung) and to the outcome. The secondary
objective is to establish whether improved microcirculatory parameter as a
consequence of standard therapy is associated with an improvement in organ
function as assessed by SOFA score. Given that IDF CytoCam is a new
technologically advanced version of hand held microscopes not yet performed in
humans, a group of patients after elective surgery and a group of healthy
volunteers will be used as control healthy microcirculation.
Study design
single-center prospective observational study
Study burden and risks
Microcirculation assessment is a noninvasive procedure, and there are no risks
associated with this monitoring device. The risks associated with participation
can be considered negligible and the burden can be considered minimal.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must be adult (> 18 yrs-old) and meet the description of the study groups stated in the section 4.2, page 13 in the protocol.
Exclusion criteria
Moribund
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 | NL45915.078.13 |