No registrations found.
ID
Source
Brief title
Health condition
Cardiac surgery, postoperative inflammation
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Inflammatory response (IL-6, CRP);
2. Myocardial damage (troponin);
3. Pathophysiology of ischemia/reperfusion injury.
Secondary outcome
N/A
Background summary
Medical research has shown that statins, in addition to their effects on the cholesterol metabolism, also have an anti-inflammatory effect. During cardiac surgery, the difference in protection between acute and long term administration of statins will be measured using myocardial ischemia reperfusion injury markers.
Study objective
This study will test the hypothesis that acute preoperative administration of statins will offer a better protection against MIRI than long term preoperative administration does.
Study design
1. Treatment: Acute or chronic (See above);
2. Blood samples will be drawn the day patients visit our clinic until 5 days after surgery.
Intervention
After giving informed consent patients will be randomized into:
1. Acute treatment: One dose of 40 mg simvastatin the evening before and one dose of 40 mg simvastatine the morning before surgery;
2. Long term treatment: 40 mg simvastatine for a minimum of 2 weeks prior to surgery.
Dpt. of Vascular Surgery.<br>
PO-box 9600
Jan H. Lindeman
Leiden 2300 RC
The Netherlands
Lindeman@lumc.nl
Dpt. of Vascular Surgery.<br>
PO-box 9600
Jan H. Lindeman
Leiden 2300 RC
The Netherlands
Lindeman@lumc.nl
Inclusion criteria
Acceptation for mitral/tricuspid valve surgery via sternotomy.
Exclusion criteria
1. Statine use;
2. Acceptation for minimal invasive surgery;
3. Ablation or CABG procedures;
4. Emergency operations;
5. Clinically diagnosed heart failure or atherosclerosis;
6. Use of corticosteroids.
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 | NL2555 |
| NTR-old | NTR2673 |
| Other | METC LUMC : P10.083 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
Bulhak et al. Am J Physio Heart Circ Physiol 2007.<br>
Birnbaum et al. J Cardiovasc Pharmacol Ther 2008.<br>
Mensah et al. J Am Coll Cardiol 2005.<br>
Liakopoulos et al. Thorac Cardiov Surg 2006.