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Recruiting EARLY_Phase 1 NCT03513770

NCT03513770 Autonomic Control of the Circulation and VDR

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Clinical Trial Summary
NCT ID NCT03513770
Status Recruiting
Phase EARLY_Phase 1
Sponsor Milton S. Hershey Medical Center
Condition Venous Distension Reflex
Study Type INTERVENTIONAL
Enrollment 18 participants
Start Date 2019-08-14
Primary Completion 2026-05-01

Trial Parameters

Condition Venous Distension Reflex
Sponsor Milton S. Hershey Medical Center
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 18
Sex ALL
Min Age 21 Years
Max Age 35 Years
Start Date 2019-08-14
Completion 2026-05-01
Interventions
Wrist-to-elbow (W-E) occlusionketorolac tromethaminesaline control

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Brief Summary

The study objective of this project is to examine the mechanisms of the venous distension reflex (VDR) in humans. We hypothesize that COX blockade with ketorolac tromethamine, an intravenous NSAID, will attenuate the muscle sympathetic nerve activity (MSNA) response to limb venous distension. To gain further insight into whether the COX byproducts directly stimulate chemically-sensitive afferents, or enable venodilation and indirectly evoke afferent stimulation, we will measure vein size using 3T MRI during venous distention with and without ketorolac infusions.

Eligibility Criteria

Inclusion Criteria * Are capable of giving informed consent * Are any race or ethnicity * Are fluent in written and spoken English * Have a satisfactory history and physical exam to meet inclusion/exclusion criteria * Are free of acute or chronic medical conditions * Are 21 - 35 years of age (inclusive) * Weigh over 50 kg Exclusion Criteria * Are less than 21 or over 35 years of age * Are Pregnant or nursing women * Are prisoners or institutionalized individuals or unable to consent * Any chronic diseases (hypertension, heart, lung, neuromuscular disease, kidney disease, diabetes or cancer). * Are taking medications that may affect their cardiovascular or nervous system * Has taken an NSAID within 48 hours of any visit (visit will need to be rescheduled) * Has never taken NSAIDs and therefore would not know if they are allergic to it * Have a supine BP \>140/90 mmHg * Have known allergy to ibuprofen-like drugs (NSAIDS) or aspirin * Have history of asthma or nasal polyps * Have history

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