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Repeated IPC ischemic preconditioning, RIPC, ischemic reperfusion injury, endothelial function, end-stage renal disease, flow-mediated dilation (FMD) ischemisch preconditioneren (IPC), herhaalde IPC, ischemisch reperfusie schade, endotheel functie, flow-gemedieerde dilatatie


- candidate number21628
- NTR NumberNTR5054
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jan-2015
- Secondary IDs2014-1344 CMO regio Arnhem-Nijmegen
- Public TitleRepeated IPC ischemic preconditioning, RIPC, ischemic reperfusion injury, endothelial function, end-stage renal disease, flow-mediated dilation (FMD) ischemisch preconditioneren (IPC), herhaalde IPC, ischemisch reperfusie schade, endotheel functie, flow-gemedieerde dilatatie
- Scientific TitleAN EXPLORATIVE STUDY TO ASSESS THE EFFECT OF REPEATED REMOTE ISCHEMIC PRECONDITIONING ON ENDOTHELIAL FUNCTION AND INNATE IMMUNE RESPONSES IN PATIENTS WITH END-STAGE RENAL DISEASE
- ACRONYM
- hypothesisIn this explorative study we will examine the impact of daily ischemic preconditioning on brachial artery endothelial function (measured as FMD%, before and after IRI) during 7 days in the non-shunt arm and lower limb in patients with end-stage renal disease. Also the effects of repeated RIPC on ex vivo innate immune responses will be explored as well. Our primary hypothesis is that RIPC can improve brachial artery FMD% in patients with end-stage renal disease.
- Healt Condition(s) or Problem(s) studiedChronic renal failure
- Inclusion criteriaInformed consent
Age > 18 years
Patients with chronic kidney disease (CKD stage 4 or 5)
- Exclusion criteria-The presence of a patent arterio-venous fistula (for dialysis)
-Peripheral artery occlusive disease stage III and IV. Poor peripheral skin vascular can interfere with performance of superficial femoral artery measurements
-Simultaneous participation in another interventional study
-Impossibility to perform RIPC, due to pathology of both arms (for example, sclerodermia, dystrophy, recent trauma, chronic wounds)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 4-feb-2015
- planned closingdate
- Target number of participants20
- InterventionsRemote RIPC: 4 cycles of ischemia of the forearm by inflating a blood pressure cuff around the upper arm at 200 mmHg during 5 minutes followed by 5 minutes of reperfusion. This procedure will be performed daily during 7 days.
- Primary outcomeBrachial artery endothelial function (measured as flow-mediated dilation)
- Secondary outcomeTo examine the effect of daily repeated ischemic preconditioning arm on superficial femoral artery function (measured as FMD%) during 7 days in patients with chronic kidney disease.

To examine the effect of daily repeated ischemic preconditioning on ex vivo innate immune responses
- Timepointsscreening 2 weeks in advance
informed consent 1 week in advance
testing day 1
week later testing day 2, start intervention 7 days RIPC
week later testing day 3, final visit
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Michiel C. Warlé
- CONTACT for SCIENTIFIC QUERIESDr. Dick H.J. Thijssen
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- Publications
- Brief summaryTo examine the effect of daily repeated ischemic preconditioning on brachial artery endothelial function (measured as FMD%) during 7 days in patients with chronic kidney disease.

Explorative, single-center study

20 patients with chronic kidney disease stage 4-5.

Remote RIPC: 4 cycles of ischemia of the forearm by inflating a blood pressure cuff around the upper arm at 200 mmHg during 5 minutes followed by 5 minutes of reperfusion

Main study parameters/endpoints: Brachial artery endothelial function (measured as flow-mediated dilation).
- Main changes (audit trail)
- RECORD30-jan-2015 - 18-apr-2015


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