The objective of this study is to determine if patients without heart failure receiving Sevoflurane have a different myocardial ischemia-reperfusion injury and/or systemic inflammatory response than patients who do not receive Sevoflurane.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We want to assess the contribution of Sevoflurane on oxidative damage,
complement, endothelial, thrombocyt and neutrophil activation and inflammation
to human ischemia reperfusion injury. Obtained data will provide information
about possible protection against ischemia reperfusion injury and the possible
contribution of Sevoflurane to attenuate SIRS, leading to a decline in
morbidity and mortality rates.
Secondary outcome
not applicable
Background summary
MIRI (myocardial ischemia reperfusion injury) is the paradoxical exacerbation
of myocardial damage upon restoration of blood supply to previously ischemic
myocardial tissue and is considered the major, inevitable, cause of tissue
damage after ischemic events such as myocardial infarction and cardiac surgery.
The pathophysiology of MIRI is complex and its exact mechanisms have not been
fully elucidated yet. However, it is conceived that reperfusion results in
endothelial damage, free radical production, complement, neutrophil and
thrombocyte activation, and cytokine release, which ultimately result in an
inflammatory reaction. Release of pro-inflammatory cytokines from the
myocardium induced by MIRI is not limited to the organ itself but also
contributes to activation of systemic vascular endothelium, clinically
recognized as SIRS (systemic inflammatory response syndrome).
Study objective
The objective of this study is to determine if patients without heart failure
receiving Sevoflurane have a different myocardial ischemia-reperfusion injury
and/or systemic inflammatory response than patients who do not receive
Sevoflurane.
Study design
Single center observational study
Study burden and risks
The proposed study aims to optimize the surgical treatment. The measurements
necessary to assess the defined study endpoints are not expected to negatively
influence the result of treatment. The use of the catheter will have an
insignificant risk.
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Patients without heart failure (EF below 35%) accepted for mitral valve surgery via sternotomy
Exclusion criteria
Acceptation for minimal invasive mitral valve surgery, inability to sign informed consent, less than 18 years old, emergency operations
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| EudraCT | EUCTR2009-012372-27-NL |
| CCMO | NL28293.058.09 |