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Autonomic Control of the Circulation and VDR

Study acronym: VDR
StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Primary completion moved earlier from Jun 1, 2027 to Nov 1, 2026
    • Study completion pushed from Aug 31, 2027 to Nov 1, 2027
    v14
  2. Primary completion date: May 1, 2026 to Jun 1, 2027
    • Study completion date: May 30, 2026 to Aug 31, 2027
    • Site contact updated
    • Collaborators expanded, about 7 words
    v13
  3. Site contact updatedv12
  4. Primary completion date: Jul 1, 2025 to May 1, 2026
    • Study completion date: Jul 1, 2025 to May 30, 2026
    • Site contact updated
    v11
  5. Primary completion date: Jul 1, 2024 to Jul 1, 2025v10
Show 8 earlier versionsHide 8 earlier versions
  1. 3 versions Re-verified since Jan 10, 2022, no change to tracked fieldsv7-v9
  2. Trial status: Suspended to Recruiting
    • Start date: Jul 12, 2017 to Aug 14, 2019
    • Site details revised
    v6
  3. Trial status: Recruiting to Suspended Sponsor's reason: Temporarily suspended due to Pandemic
    • Site details revised
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Primary completion date: Jul 2022 to Jul 1, 2024v3 Show 8 more changesShow less
    • Primary endpoints: 1 to 2
    • Study completion date: Jul 2022 to Jul 1, 2025
    • Interventions: Control (Other), Ketorolac Tromethamine (Drug) to Wrist-to-elbow (W-E) occlusion (Other), ketorolac tromethamine (Drug), saline control (Drug)
    • Secondary endpoints: 3 to 5
    • Study description shortened, about 250 words
    • Site contact updated
    • Eligibility criteria shortened, about 2 words
    • Study title shortened, about 3 words
  6. Primary completion date: Jul 2019 to Jul 2022
    • Study completion date: Jul 2020 to Jul 2022
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03513770
Lead Sponsor Milton S. Hershey Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Venous Distension Reflex, Blood Pressure
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov