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

Phase 2

Completed

• Conditions: perfusion dysregulation; vascular ischemia; 10011082; 10003216

• Registration Number: NL-OMON32361
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2012-08-16
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Healthy volunteers aged 18-65 years, informed consent

Exclusion Criteria

untreated arterial hypertension, known renal impairment, liver disease, cardiovascular disease (arterial hypertension, angina, previous myocardial infarction, history of stroke), history of diabetes mellitus, coagulatopathy (PTT > 1.5 times control), anti coagulation drugs, antihypertensive drugs, contra indication or intolerance to any used substance

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: Endothelial preconditioning with helium will<br /><br>be investi¬gated by measurement of forearm blood flow using the venous<br /><br>occlusion plethysmography model. Primary end-point is blood flow and reactive<br /><br>hyperemia before and after I/R with or without helium inhalation after<br /><br>stimulation with either serotonin (5HT) as an endothelium-dependent or sodium<br /><br>nitroprusside (SNP) as an endothelium-independent vasodilator.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters will be measurement as endothelial adhesion molecules on<br /><br>leukocytes. Therefore, blood samples will be collected at different time<br /><br>points.</p><br>