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ID
Source
Brief title
Health condition
immune response, helium
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. 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 outcome
N/A
Background summary
Various 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.
Study objective
Primary 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?
Study design
T0 = 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.
Intervention
1. Helium or normal air breathing through a mask for 30 minutes;
2. Blood sampling through seperate puncturing sites.
University of Amsterdam, Meibergdreef 9
Postbus 22660 H1Z-120
B. Preckel
Amsterdam 1100 DD
The Netherlands
+31 20 5662162,
b.preckel@amc.uva.nl
University of Amsterdam, Meibergdreef 9
Postbus 22660 H1Z-120
B. Preckel
Amsterdam 1100 DD
The Netherlands
+31 20 5662162,
b.preckel@amc.uva.nl
Inclusion criteria
Non-smoking, healthy, male volunteers, aged 18-45 years old.
Exclusion criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2034 |
| NTR-old | NTR2152 |
| CCMO | NL26824.018.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON33293 |