Status:

RECRUITING

Autonomic Control of the Circulation and VDR

Lead Sponsor:

Milton S. Hershey Medical Center

Conditions:

Venous Distension Reflex

Blood Pressure

Eligibility:

All Genders

21-35 years

Phase:

EARLY_PHASE1

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, wi...

Detailed Description

We will use a prospective observational design to examine if a COX blockade will inhibit the MSNA response to venous distension (Aim1), and if a COX blockade will alter vein sizes during venous disten...

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 of GI bleeding or ulcers
  • Subjects with ferromagnetic metal implants
  • Subjects who are claustrophobic

Key Trial Info

Start Date :

August 14 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 30 2026

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT03513770

Start Date

August 14 2019

End Date

May 30 2026

Last Update

September 16 2025

Active Locations (1)

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1

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033