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NCT03513770 · ClinicalTrials.gov registry record · Early Phase 1
Autonomic Control of the Circulation and VDR
A Early Phase 1 study of Blood Pressure and Venous Distension Reflex, sponsored by Milton S. Hershey Medical Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT03513770: Recruiting Early Phase 1 study of Blood Pressure and Venous Distension Reflex, sponsored by Milton S. Hershey Medical Center.
NCT03513770 is a Early Phase 1 study of Blood Pressure and Venous Distension Reflex that is actively recruiting participants, run by Milton S. Hershey Medical Center. The registered enrollment target is 18 participants, below the 287-participant average among 101 other Blood Pressure trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03513770, a Early Phase 1 study of Blood Pressure and Venous Distension Reflex, is actively recruiting participants, sponsored by Milton S. Hershey Medical Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
This technique provides direct recordings of sympathetic nerve activity directed to blood vessels in skeletal muscle and will be our primary index of sympathoexcitation. This procedure may be performed in the either leg. External mapping of the peroneal or tibial nerve course (10-60 volts, 1-5msec, 1Hz) will be performed just behind the fibular head of the leg or in the popliteal fossa. A reference electrode will be placed subcutaneously about 2-3 cm away from the recording site. Multiunit recor
Conditions Studied
Interventions
- OTHER Wrist-to-elbow (W-E) occlusion
- DRUG ketorolac tromethamine
- DRUG saline control
Study Locations (1)
Pennsylvania
- Penn State Milton S. Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-08-14 |
| Est. Completion | 2026-05-30 |
| Phase | Early Phase 1 |
What NCT03513770 shows while recruiting
NCT03513770 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 287-participant average among 101 other Blood Pressure trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Blood Pressure appearing as the primary indexed condition, and to 3 interventions - of which Wrist-to-elbow (W-E) occlusion is the first listed.
NCT03513770 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03513770 about?
NCT03513770 is a clinical study titled "Autonomic Control of the Circulation and VDR". 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 gai...
What is the current status of trial NCT03513770?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 18 participants. The study started on 2019-08-14. Estimated completion is 2026-05-30.
What conditions does trial NCT03513770 study?
This clinical trial studies the following conditions: Blood Pressure, Venous Distension Reflex.
What interventions are being tested in trial NCT03513770?
The interventions under investigation include: Wrist-to-elbow (W-E) occlusion (OTHER), ketorolac tromethamine (DRUG), saline control (DRUG).
Who is sponsoring clinical trial NCT03513770?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03513770 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03513770's enrollment target sits among peer trials
18 90th of 101 higher than 11 of 101 other Blood Pressure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Blood Pressure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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