Clinical trial NCT02353390: Oral Water Hydration to Prevent Post-Vaccination Presyncope
Official title: Feasibility and Impact of Implementing an Oral Water Hydration Strategy to Prevent Post-Vaccination Presyncope and Syncope in Adolescents and Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presyncope
Syncope
Keywords: presyncope
syncope
adolescent
young adult
immunization
vaccination
water consumption
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Boston University
First posted: 2015-02-02
Enrollment: 1820
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Presyncope
timeFrame: 20 minutes
measure: Acceptability of oral water hydration in the intervention group, assessed by qualitative reports in the post-vaccination observation period and response to a survey about whether they liked getting water.
timeFrame: 20 minutes
Secondary outcomes:
measure: Syncope
timeFrame: 20 minutes
measure: Alternative Case Definition of Presyncompe
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Alex R Kemper, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Elizabeth D Barnett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Theresa Harrington, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Braun MM, Patriarca PA, Ellenberg SS. Syncope after immunization. Arch Pediatr Adolesc Med. 1997 Mar;151(3):255-9. doi: 10.1001/archpedi.1997.02170400041007.
citation: National Center for Immunization and Respiratory Diseases. General recommendations on immunization --- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011 Jan 28;60(2):1-64.
citation: Centers for Disease Control and Prevention (CDC). Syncope after vaccination--United States, January 2005-July 2007. MMWR Morb Mortal Wkly Rep. 2008 May 2;57(17):457-60.
citation: Hanson SA, France CR. Predonation water ingestion attenuates negative reactions to blood donation. Transfusion. 2004 Jun;44(6):924-8. doi: 10.1111/j.1537-2995.2004.03426.x.
citation: Newman B, Tommolino E, Andreozzi C, Joychan S, Pocedic J, Heringhausen J. The effect of a 473-mL (16-oz) water drink on vasovagal donor reaction rates in high-school students. Transfusion. 2007 Aug;47(8):1524-33. doi: 10.1111/j.1537-2995.2007.01293.x.
citation: Soteriades ES, Evans JC, Larson MG, Chen MH, Chen L, Benjamin EJ, Levy D. Incidence and prognosis of syncope. N Engl J Med. 2002 Sep 19;347(12):878-85. doi: 10.1056/NEJMoa012407.