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NCT02353390 · ClinicalTrials.gov registry record · NA
Oral Water Hydration to Prevent Post-Vaccination Presyncope
A NA study of Syncope and Presyncope, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 1,820
- Enrollment target
- 2
- Study locations
NCT02353390: Completed NA study of Syncope and Presyncope, sponsored by Duke University.
NCT02353390 is a NA study of Syncope and Presyncope that has completed, run by Duke University. The registered enrollment target is 1,820 participants, above the 686-participant average among 11 other Syncope trials with a reported enrollment target (165% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02353390, a NA study of Syncope and Presyncope, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,820 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a randomized controlled open-label trial. During the study, adolescents and young adults scheduled to receive at least one intra-muscular (IM) vaccine will receive either oral water hydration in addition to standard care or standard of care alone to evaluate the effect of water hydration on the primary outcome of presyncope. This study will also evaluate the acceptability of pre-vaccination hydration among adolescents and young adults.
Primary Outcome
Sudden onset of one or more of the following symptoms or signs during the post-vaccination observation period in the clinic: Symptoms * Feeling lightheaded, like you might "pass out" or faint * Feeling dizzy, like the room is spinning * Feeling weak * Feeling like your face is getting red and warm (or hot), like blushing * Noticing any change in your vision, like spots or flickering lights, tunnel vision, or loss of vision * Experiencing ringing in your ears, decreased hearing, or sounds seem
Conditions Studied
Interventions
- OTHER Oral Water Hydration
Study Locations (2)
Massachusetts
- Boston Medical Center - Boston
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,820 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-06 |
| Phase | NA |
What the finished NCT02353390 record still lists
NCT02353390 is an interventional study that assigns participants to a tested intervention. Its 1,820 participants enrollment target places it among the larger protocols in the corpus, above the 686-participant average among 11 other Syncope trials with a reported enrollment target (165% higher).
The record links to 2 conditions, with Syncope appearing as the primary indexed condition, and to 1 intervention - of which Oral Water Hydration is the first listed.
NCT02353390 reports a single indexed study location in Massachusetts, North Carolina.
Frequently Asked Questions
What is clinical trial NCT02353390 about?
NCT02353390 is a clinical study titled "Oral Water Hydration to Prevent Post-Vaccination Presyncope". This is a randomized controlled open-label trial. During the study, adolescents and young adults scheduled to receive at least one intra-muscular (IM) vaccine will receive either oral water hydration in addition to standard care or standard of care alone to evaluate the effect of water hydration on ...
What is the current status of trial NCT02353390?
This trial is currently completed. It is a NA study. The enrollment target is 1,820 participants. The study started on 2015-03. Estimated completion is 2016-06.
What conditions does trial NCT02353390 study?
This clinical trial studies the following conditions: Syncope, Presyncope.
What interventions are being tested in trial NCT02353390?
The interventions under investigation include: Oral Water Hydration (OTHER).
Who is sponsoring clinical trial NCT02353390?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02353390 being conducted?
This trial has 2 study locations across Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02353390's enrollment target sits among peer trials
1,820 2nd of 11 the highest of 11 other Syncope trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Syncope 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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