Oral Water Hydration to Prevent Post-Vaccination Presyncope

Duke University

Status

Completed

Conditions

Syncope

Presyncope

Treatments

Other: Oral Water Hydration

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT02353390

200-2012-53663 0005 (Other Grant/Funding Number)

Pro00060114

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,820 patients

Sex

All

Ages

11 to 21 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

The subject must be 11 years through 21 years of age
The subject must be receiving at least one IM vaccine
If the subject is younger than 18 years and not able to give independent consent under the applicable laws of the local jurisdiction, the parent/guardian must be willing and capable of providing written informed consent for the child and the child must be willing and capable of providing assent OR if the subject is 18 years or older or younger than 18 years and able to give independent consent under the applicable laws of the local jurisdiction, the subject must be willing and capable of providing written informed consent.
The subject must be willing to stay for the completion of all study-related activities.
The subject must be willing to try to drink up to 500 ml water in a pre-specified period of time (15 minutes) prior to receipt of prescribed vaccines.

Exclusion criteria

No experimental vaccine or medication within the previous two weeks
No daily injectable medication
No permanent indwelling venous catheter
No blood drawn within the past hour or scheduled for a blood draw during the post-vaccination observation period
Any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol