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The effect of helium on the immune system.


- candidate number6845
- NTR NumberNTR2152
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-jan-2010
- Secondary IDsNL2682401809 / 2009-010078-39 
- Public TitleThe effect of helium on the immune system.
- Scientific TitleThe effect of helium on the immune system ex vivo (HeLIX).
- ACRONYMHeLIX
- hypothesisPrimary objective: Does a 30-minute episode of helium breathing in humans decrease the amount of pro-inflammatory cytokines and chemokines produced in whole blood after immunostimulation ex vivo?
- Healt Condition(s) or Problem(s) studiedHelium, Immune respons
- Inclusion criteriaNon-smoking, healthy, male volunteers, aged 18-45 years old.
- Exclusion criteria1. Smoking; current or in past six months;
2. Alcohol or drug abuse;
3. Allergic reaction to medication in past medical history;
4. Chronic medication or presence of any condition that could influence the immune system.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2009
- planned closingdate1-apr-2010
- Target number of participants12
- Interventions1. Helium or normal air breathing through a mask for 30 minutes;
2. Blood sampling through seperate puncturing sites.
- Primary outcome1. Proinflammatory cytokines in whole blood: Il-1beta, Il-6, TNF-alpha;
2. Chemokine: Il-8, T-cell products Il-2, INF-gamma;
3. Neutrophil degranulation product: elastase.
- Secondary outcomeN/A
- TimepointsT0 = 15 mins before start of helium or room air breathing;
T1 = After 25 mins of helium/room air breathing;
T2 = 60 mins after helium/room air breathing;
T3 = Two hours after helium/room air breathing;
T4 = Six hours after helium/room air breathing;
T5 = 24 hours after helium/room air breathing.
- Trial web sitenot applicable
- statusinclusion stopped: follow-up
- 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 Centre, Department of Experimental and Clinical Anesthesiology
- PublicationsN/A
- Brief summaryVarious studies have shown protective effects of helium inhalation on ischemia/reperfusion damage in mycoardial and cerebral tissue. Based on these findings we want to investigate whether an extended episode of helium inhalation has any effect on the immune response. This is an explorative study with a cross-over design, using the principle of balanced assignment in a group of 12 healthy, male volunteers. The main endpoints are proinflammatory cytokines, chemokines, T-cell products and the neutrophil product elastase.
- Main changes (audit trail)
- RECORD4-jan-2010 - 14-jan-2010


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