Oral Water Hydration to Prevent Post-Vaccination Presyncope

Syncope Clinical Trial

Official title:

Feasibility and Impact of Implementing an Oral Water Hydration Strategy to Prevent Post-Vaccination Presyncope and Syncope in Adolescents and Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02353390
• Other study ID #: Pro00060114
• Secondary ID: 200-2012-53663 0
• Status: Completed
• Phase: N/A
• First received: January 28, 2015
• Last updated: July 5, 2016
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1820
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 21 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Presyncope
• Syncope

Intervention

Other:
• Oral Water Hydration
Subjects in the hydration group will be allowed up to 15 minutes to drink up to 500 milliliters (mL) of water prior to the vaccines. Subjects will be encouraged to drink the entire 500 mL; however, they are free to drink as much as they want and can finish before the end of the 15-minute period. Subjects will be instructed not to share the water and to not otherwise empty the bottle. As with the control group, subjects will be instructed not to eat or drink anything else for the duration of the study, unless clinically indicated (e.g., as part of management of presyncope or syncope).

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Boston University, Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (6)

Braun MM, Patriarca PA, Ellenberg SS. Syncope after immunization. Arch Pediatr Adolesc Med. 1997 Mar;151(3):255-9. — View 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. — View Citation

Hanson SA, France CR. Predonation water ingestion attenuates negative reactions to blood donation. Transfusion. 2004 Jun;44(6):924-8. — View 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. Erratum in: MMWR Recomm Rep. 2011 Jul 29;60:993. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presyncope	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 far away; Feeling like your heart is beating fast or hard or pounding; Feeling hot AND sweaty; Feeling cold AND sweaty, or "clammy"; Feeling like you are breathing fast or hard; Feeling like you might throw up (nausea); Signs; Pallor; Sweaty; Facial flush; Decreased interactivity (decreased level of arousal or responsiveness); AND; Not Syncope; Not due to another cause; Not clearly present at baseline	20 minutes	No
Primary	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.		20 minutes	No
Secondary	Syncope	Syncope (fainting) that occurs in an otherwise healthy person after receipt of a vaccine or during venipuncture is usually attributed to vasovagal syncope, and may occur alone (simple syncope) or may be associated with tonic-clonic movements (convulsive syncope, anoxic seizure). For the purposes of this study, we have defined syncope as: Any sudden and brief loss of consciousness or postural tone after vaccination from which recovery is spontaneous and is not attributed to another cause (e.g., anaphylaxis). For purposes of this study, cases counted as syncope must occur during the post-vaccination observation period.; Individuals that develop syncope after presyncope will be classified only as having syncope.	20 minutes	No
Secondary	Alternative Case Definition of Presyncompe	In secondary analysis, the case definition of presyncope (Outcome 1) will be defined as any response of self-report of the symptoms of presyncope at a level of "somewhat," "a lot," or "extremely" compared to "none" or "a little."	20 minutes	No