To assess the course of microcirculatory disturbances during ECMO. Furthermore, we will evaluate the effect of implementation of ROTEM in terms of thrombotic and hemorrhagic events and the use of blood products in patients on ECMO.
ID
Source
Brief title
Condition
- Heart failures
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in endothelial permeability markers prior to ECMO and at day 3.
Secondary outcome
Change in coagulation parameters
The use of blood and coagulation products
Incidence of thrombotic and hemorrhagic events
Change in microcirculatory perfusion parameters.
Background summary
Extracorporeal membrane oxygenation (ECMO) is used as a supportive method in
case of potentially reversible cardio(respiratory) failure, refractory to
conventional therapies. Although the techniques have improved, reported
mortality remains between 40-80%. Due to extracorporeal circulation, ECMO is
associated with a systemic inflammatory response. This inflammatory response
may activate the endothelium, resulting in a permeable endothelium.
Consequently, leakage of fluid to the interstitium and ensuing tissue oedema
contribute to the development of microcirculatory perfusion disturbances.
Previous research in patients following cardiopulmonary bypass (CPB) shows that
microcirculatory hypoperfusion persists for days. In rats following CPB, we
have found that microcirculatory perfusion disturbances coincide with
microvascular leakage, a dysregulated endothelial angiopoietin/Tie2 system and
kidney injury. The angiopoietin/Tie2 system tightly regulates endothelial
barrier function, and disturbances in this system can cause microvascular
leakage. In critically ill patients supported with ECMO, knowledge on this
system is sparse.
Therefore, increased understanding of mechanisms of loss of endothelial barrier
function and microcirculatory perfusion are required to find new targets for
therapeutic possibilities to reduce morbidity and mortality in these critically
ill patients.
Taken together, our aim is to assess changes of endothelial permeability
markers in patients on ECMO. We hypothesize that ECMO-induced inflammation
leads to endothelial dysfunction and oedema formation thereby disturbing
microcirculatory perfusion and contributing to organ failure.
Study objective
To assess the course of microcirculatory disturbances during ECMO. Furthermore,
we will evaluate the effect of implementation of ROTEM in terms of thrombotic
and hemorrhagic events and the use of blood products in patients on ECMO.
Study design
Prospective, observational, cohort study
Study burden and risks
The burden and risk associated with participation are negligible. Blood samples
will be obtained from an arterial line and non-invasive sublingual
microcirculatory perfusion measurements will be performed.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Patients expected to be admitted to the Intensive Care Unit (ICU) within 24
hours;
- The indication for either VV-ECMO or VA-ECMO;
- Arterial line to enable blood sampling;
- Older than 18 years;
* (Deferred) informed consent.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Contraindications for ECMO;
- ECMO is initiated in another centre and patient is transferred on ECMO >24
hours after initiation of ECMO;
- No (deferred) informed consent.
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 | NL75834.018.20 |