No registrations found.
ID
Source
Brief title
Health condition
Sevoflurane, Cardiac Surgery, Inflammation, Preconditioning
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Factors related to the acute inflammatory response (IL-6, ICAM e.d.);
2. Factors likely involved in pathophysiology of I/R injury (cytokines);
3. Markers of myocardial injury (Trop/CK-MB).
Secondary outcome
1. Factors related to the acute inflammatory response (IL-6, ICAM e.d.);
2. Factors likely involved in pathophysiology of I/R injury (cytokines);
3. Markers of myocardial injury (Trop/CK-MB).
Background summary
In this study we will include a homogenous group to obtain information about the underlying mechanisms of influencing the inflammatory component by Sevoflurane. Obtained data will provide information about possible protection against I/R injury and the possible contribution of Sevoflurane to attenuate the inflammatory response, leading to a decline in morbidity and mortality rates.
Study objective
This study will test the hypothesis that Sevoflurane attenuates oxidative damage, complement, enothelial, thrombocyt and neutrophil activation and inflammation to human ischemia reperfusion injury of the myocardium.
Study design
Baseline, OR and ICU (till 24 hours after surgery).
Intervention
Sevoflurane will be added to the blood cardioplegia mixture in the treatment cohort. The control-cohort will receive oxygen. Addition only when Heart-lungmachine is activated.
Blook will be taken several times, starting from 1 day pre-OR to 5 days post-OR.
Department of CardioThoracic Surgery,
room D6-53,
P.O. Box 9600
R.J.M. Klautz
Leiden 2300 RC
The Netherlands
+31 (0)71 5264022
r.j.m.klautz@lumc.nl
Department of CardioThoracic Surgery,
room D6-53,
P.O. Box 9600
R.J.M. Klautz
Leiden 2300 RC
The Netherlands
+31 (0)71 5264022
r.j.m.klautz@lumc.nl
Inclusion criteria
1. Acceptation for mitral valve surgery via sternotomy;
2. LV ejection fraction > 35%.
Exclusion criteria
1. Acceptation for minimal invasive valve surgery;
2. Use of systemic corticosteroids;
3. Inability to introduce coronary sinus catheter;
4. Inability to sign informed consent or less than 18 years old;
5. Emergency operations.
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 |
|---|---|
| NTR-new | NL1972 |
| NTR-old | NTR2089 |
| Other | METC LUMC Leiden : P09.136 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |