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van CCT (UK)

van CCT (UK)

Organ protection by helium gas inhalation: protective factors in the blood

- candidate number17371
- NTR NumberNTR4507
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-apr-2014
- Secondary IDs2014_045 METC nummer
- Public TitleOrgan protection by helium gas inhalation: protective factors in the blood
- Scientific TitleHelium induced organ protection and the role of circulatory factors: secretion of Caveolin to the bloodstream
- hypothesisWe hypothesize that inhalation of helium gas induces release of protective factors in the blood, which can be used to protect different cell types against ischemia/reperfusion injury.
- Healt Condition(s) or Problem(s) studiedIschemia / Reperfusion injury
- Inclusion criterianon-smoking, healthy male volunteers, aged 20-55 years
- Exclusion criteria-Active smoking or smoking in the previous six months
-Alcohol abuse or use of recreational drugs
-Any allergic reaction on medication in the past
-Presence of a chronic disease that is under current medical observation and needs pharmacological treatment, e.g. asthma, high blood pressure or diabetes
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate1-dec-2015
- Target number of participants20
- Interventions- Inhalation of helium or air
- Blood sampling by venous puncture
- Primary outcome- Cell damage such as LDH, apoptosis markers
- Expression of Cav-1 and Cav-3 in blood
- Secondary outcome- If Cav-levels are significantly different after helium inhalation, cells will be incubated with cav-antibodies
- Timepointstimepoints blood sampling: T0 (baseline), T1 (directly after inhalation), T2 (6 h after inhalation), T3 (24 h after inhalation)
- Trial web site-
- statusplanned
- Sponsor/Initiator Academic Medical Center (AMC), Department of Anesthesiology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Anesthesiology, Society of Cardiovascular Anesthesiologists
- PublicationsSmit KF, Oei GTML, Stroes ES, Nieuwland R, Schlack W, Hollmann MW, Weber NC, Preckel B: Helium induces preconditioning in the human endothelium in vivo. Anesthesiology 2013 Jan;118(1):95-104
Oei GTML, Smit KF, van de Vondenvoort D, Wieland CW, Hollmann MW, Preckel B, Weber NC; The effect of helium inhalation on the innate and early adaptive immune system ex vivo. J Transl Med 2012;10:201
Oei GTML, Huhn R, Heinen A, Hollmann MW, Schlack WS, Preckel B, Weber NC: Helium-induced cardioprotection of healthy and hypertensive rat myocardium in vivo. Eur J Pharmacol 2012; 684:125-131
Berger MM, Huhn R, Oei GTML, Heinen A, Winzer A, Preckel B, Weber NC, Schlack W, Hollmann MW: Hypoxia induces late preconditioning in the rat heart in vivo. Anesthesiology 2010; 113:1351-60
Oei GTML, Weber NC, Hollmann MW, Preckel B: Cellular effects of helium in different organs. Anesthesiology 2010; 112:1503-10.
Huhn R HA, Weber NC, Kerindongo R, Oei GTML, Hollmann MW, Schlack W, Preckel B: Helium-induced early preconditioning and postconditioning is abolished in obese Zucker rats in vivo. J Pharmacol Exp Ther 2009; 329:600-7
- Brief summaryHelium induces organ protection, but currently its mechanisms of action are unclear. This trial investigates the underlying mechanisms of helium-induced protection. We hypothesize that helium inhalation results in the release of "protective" mediators in the blood, which are transported to tissue at risk for ischemia/reperfusion damage. This is investigated in the current study in which healthy volunteers will breathe helium, after which blood will sampled. Different cells exposed to hypoxia/reoxygenation in vitro, will be incubated with this blood, and we will investigate whether a reduction in cell damage can be found.
- Main changes (audit trail)
- RECORD13-apr-2014 - 8-mei-2014

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