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A study on organ protection during bypass sugery by inflating a bloodpressure cuff on the arm.


- candidate number6162
- NTR NumberNTR1931
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-jul-2009
- Secondary IDsMEC 09/008 Medical Ethical Committee, AMC, University of Amsterdam
- Public TitleA study on organ protection during bypass sugery by inflating a bloodpressure cuff on the arm.
- Scientific TitleA clinical study to investigate the molecular effects of remote ischemic preconditioning in the myocardium of CABG patients.
- ACRONYMRIPC-CABG
- hypothesisRecent clinical data showed that remote ischemic preconditioning attenuates myocardial damage during cardiac surgery. Classic preconditioning is abolished in diabetic patients. We will investigate the molecular effects of remote ischemic preconditioning on the myocardium, in both diabetics and non-diabetics.
- Healt Condition(s) or Problem(s) studiedCoronary Artery Bypass Grafting (CABG), Cardioprotection, Remote preconditioning
- Inclusion criteria1. CABG surgery with or without valve surgery;
2. Informed consent;
3. Age >18 years.
- Exclusion criteria1. Emergency surgery;
2. Heart failure;
3. Serious pulmonary disease;
4. Kidney failure.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 28-jul-2009
- planned closingdate1-dec-2010
- Target number of participants56
- InterventionsRemote ischemic preconditioning: By inflating a automateic inflator cuff around the upper arm, we will induce forearm ischemia for 5 minutes, followed by 5 minutes of reperfusion. This cylce will be repeated 2 times.
In the control group the cuff will be placed on the upper arm, but no inflating will be done.
- Primary outcomeDifferences in phosphorylation of PKC-e, p38MAKP, ERK and HSP27, before and after remote preconditioing, as compared to control.
- Secondary outcomeN/A
- TimepointsTwo myocardial biopsies will be obtained, the first after sternotomy and the second 30 minutes later, but prior to cardiopulmonary bypass.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, MA, DEAA B. Preckel
- CONTACT for SCIENTIFIC QUERIESMD, MA, DEAA B. Preckel
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryThe aim of this clinical study is to investigate whether remote ischemic preconditioning induces a phosphorylation of signalling pathway molecules, such as PKC-e, p38MAPK, ERK and HSP27, in human myocardium.
- Main changes (audit trail)
- RECORD27-jul-2009 - 11-okt-2009


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