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Organ protection by noble gases Helium induced Early and Late Preconditioning (HELP) in human endothelium.


- candidate number2868
- NTR NumberNTR1124
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-nov-2007
- Secondary IDs07/302 MEC
- Public TitleOrgan protection by noble gases Helium induced Early and Late Preconditioning (HELP) in human endothelium.
- Scientific TitleOrgan protection by noble gases Helium induced Early and Late Preconditioning (HELP) in human endothelium.
- ACRONYMHELP
- hypothesisHeliuminduces early and late preconditioning after regional ischemia of the arm.
- Healt Condition(s) or Problem(s) studiedHealthy subjects
- Inclusion criteriaHealthy volunteers aged 18-65 years, informed consent.
- Exclusion criteria1. Alcohol consumption;
2. untreated arterial hypertension;
3. known renal impairment;
4. liver disease;
5. cardiovascular disease (arterial hypertension, angina, previous myocardial infarction, history of stroke);
6. history of diabetes mellitus;
7. coagulatopathy (PTT > 1.5 times control);
8. anti coagulation drugs;
9. lipid-lowering drugs;
10. antihypertensive drugs;
11. antioxidant vitamins intake and known hypersensitivity;
12. contra indication or intolerance to any used substance.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2008
- planned closingdate31-dec-2010
- Target number of participants55
- InterventionsHelium application before forearm ischemia.
- Primary outcomeThe present application of helium seeks to investigate the possibility to precondition human endothelium with helium. This will be done by measurement of forearm blood flow using the venous occlusion plethysmography model. Primary end-point is blood flow and reactive hyperemia before and after ischemia reperfusion after stimulation with either serotonin as an endothelium-dependent vasodilator or sodium nitroprusside as an endothelium-independent vasodilator.
- Secondary outcomeSecondary parameters will be measurement as endothelial adhesion molecules on leukocytes.
- TimepointsN/A
- 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), Department of Anesthesiology
- Funding
(Source(s) of Monetary or Material Support)
IARS
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD9-nov-2007 - 3-apr-2008


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