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The Sevoflurane study, understanding the effects of Sevoflurane to improve safety and outcome of cardiac surgery.


- candidate number6681
- NTR NumberNTR2089
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-okt-2009
- Secondary IDsP09.136 METC LUMC Leiden
- Public TitleThe Sevoflurane study, understanding the effects of Sevoflurane to improve safety and outcome of cardiac surgery.
- Scientific TitleThe Sevoflurane study, understanding the effects of Sevoflurane to improve safety and outcome of cardiac surgery.
- ACRONYMThe Sevo-study
- hypothesisThis 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.
- Healt Condition(s) or Problem(s) studiedHeart surgery
- Inclusion criteria1. Acceptation for mitral valve surgery via sternotomy;
2. LV ejection fraction > 35%.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2009
- planned closingdate1-mei-2011
- Target number of participants40
- InterventionsSevoflurane 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.
- Primary outcome1. 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 outcome1. 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).
- TimepointsBaseline, OR and ICU (till 24 hours after surgery).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. R.J.M. Klautz
- CONTACT for SCIENTIFIC QUERIESMSc. K.A. Kortekaas
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Centre, Department of Thoracic Surgery
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD30-okt-2009 - 12-nov-2009


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