In 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…
ID
Bron
Aandoening
To examine the effect of daily repeated ischemic preconditioning on brachial artery endothelial function (measured as FMD% before and after IRI) during 7 days in patients with chronic kidney disease.
We will recruit 20 subjects with chronic kidney disease. The presence of a patent arterio-venous fistula (for dialysis) and peripheral artery occlusive disease (stage Fontaine 3-4) are taken as exclusion criteria. Also patients with pathology of both arms (for example, sclerodermia, dystrophy, recent trauma, chronic wounds) will be excluded.
Ondersteuning
Telefoon: 024-3615333
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Brachial artery endothelial function (measured as flow-mediated dilation)
Achtergrond van het onderzoek
To 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).
Doel van het onderzoek
In 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.
Onderzoeksopzet
screening 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
Onderzoeksproduct en/of interventie
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. This procedure will be performed daily during 7 days.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Informed consent
Age > 18 years
Patients with chronic kidney disease (CKD stage 4 or 5)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-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)
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4949 |
| NTR-old | NTR5054 |
| Ander register | CMO regio Arnhem-Nijmegen : 2014-1344 |