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Protection of the heart during bypass surgery by a blood pressure cuff on the arm.


- candidate number9489
- NTR NumberNTR2915
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-mei-2011
- Secondary IDs2011_067 METC AMC
- Public TitleProtection of the heart during bypass surgery by a blood pressure cuff on the arm.
- Scientific TitleA clincical study to investigate the effects of remote ischemic preconditioning on cardiac mitochondrial hexokinase in coronary artery bypass graft patients.
- ACRONYMmtHK-RIPC
- hypothesisRemote ischemic preconditioning (RIPC) has been shown to attenuate myocardial damage in cardiac surgery. We hypthesize that RIPC induced cardioprotection is associated with an increased amount of mitochondrial hexokinase.
- Healt Condition(s) or Problem(s) studiedCoronary Artery Bypass Grafting (CABG), Cardioprotection, Remote preconditioning
- Inclusion criteria1. Age > 18 years;
2. First time elective on-pump CABG surgery without valve surgery;
3. Signed written informed consent.
- Exclusion criteria1. Emergency operation;
2. Women;
3. Severe COPD;
4. SaO2 < 90% at room temperature;
5. Presumed non cooperatives;
6. Ejection fraction < 40%;
7. Diabetes or representing with hyperglycemia;
8. Unstable angina or angina 48h before surgery;
9. Peripheral vascular disease affecting the upper limbs;
10. Concomitant procedures;
11. Nicorandil use;
12. Increased preoperative cardiac troponin T;
13. Pre-/peri-operative morphin use;
14. Myocardial infarction within 2 weeks before surgery.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2012
- planned closingdate31-dec-2014
- Target number of participants46
- InterventionsRemote ischemic preconditioning: Will be induced by an automated cuff deflator placed on the left arm and inflated to 200 mmHg for 5 min 3 times, with subsequent reperfusion during which the cuff is deflated for 5 min.
The control group will have a deflated cuff for 30 min, and will receive no ischemic preconditioning.
- Primary outcomeCardioprotection measured by cardiac troponin T values and the hexokinase mitochondrial binding ratio.
- Secondary outcomeInotropic score, plasma cytokine levels (IL-6, IL-10 and TNF-alfa) and CRP.
- TimepointsOne myocardial biopsy will be obtained after RIPC, after cannulation of the appendix of the right atrium, which is necessary for installation of the venous cannulator the extracorporeal circulation. Blood samples will be taken before RIPC is performed and 5 min after RIPC for determination of cytokine levels. Furthermore blood samples for determination of troponin T and CRP will be taken before surgery and 6, 12, 24 and 48 hours after surgery.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. Ir. Coert J. Zuurbier
- CONTACT for SCIENTIFIC QUERIESDr. Ir. Coert J. Zuurbier
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Dutch Heart Foundation (Nederlandse Hartstichting)
- PublicationsNederlof, Rianne, et al. "A randomized trial of remote ischemic preconditioning and control treatment for cardioprotection in sevoflurane-anesthetized CABG patients." BMC anesthesiology 17.1 (2017): 51.
- Brief summaryThe aim of this clinical study is to investigate whether mitochondrial hexokinase binding ratio in the heart is a good predictor of cardiac troponin T after remote ischemic preconditioning.
- Main changes (audit trail)
- RECORD25-mei-2011 - 29-apr-2017


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