Oral Water Hydration to Prevent Post-Vaccination Presyncope

Status Completed

Clinical Trial 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.

Clinical Trial Description

Post-vaccination syncope is a rare but potentially serious adverse event in adolescents and young adults. Because few data are available regarding post-vaccination syncope, evidence regarding presyncope and syncope after blood donation provides useful insight. Based on studies of blood donors, acute water loading fifteen minutes prior to vaccination with 500 mL of water might reduce the risk of syncope. However, the degree to which hydration attenuates the risk of post-vaccination syncope or presyncope is unknown. Furthermore, little is known about the acceptability of pre-vaccination hydration to adolescents and young adults.

The objective of this study is to conduct a study to evaluate the acceptability and impact of oral hydration to prevent presyncope following vaccination in adolescents and young adults 11 through 21 years of age. The primary objectives are to determine if pre-vaccination hydration decreases the rate of presyncope in adolescents and young adults receiving at least one intra-muscular (IM) vaccine and to determine if pre-vaccination hydration is acceptable to adolescents and young adults.

This is a randomized controlled open-label study in adolescents and young adults receiving at least one IM vaccine. Vaccine administration will be part of routine care and will not be a study procedure. Adolescents and young adults 11- through 21 years of age will be eligible for participation. Minimal subject exclusion criteria will be used to best reflect how pre-vaccination hydration could be used outside of the controlled trial setting. For all primary and secondary objectives, data will be collected before and after vaccination, with data collection to be completed on the day of enrollment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02353390
Study type	Interventional
Source	Duke University
Contact
Status	Completed
Phase	N/A
Start date	March 2015
Completion date	June 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.