Oral Water Hydration to Prevent Post-Vaccination Presyncope

NCT02353390 | Completed

• 2 other identifiers: Pro00060114200-2012-53663 0005
• Study Type: interventional
• Target: 1,820
• Locations: 1 country
• Sites: 2

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.

Conditions

Presyncope; Syncope

Keywords

presyncope; syncope; adolescent; young adult; immunization; vaccination; water consumption

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Syncope

  20 minutes

• Alternative Case Definition of Presyncompe

  20 minutes

Study Arms (2)

Oral Water Hydration

ACTIVE COMPARATOR

Subjects will be given up to 15 minutes to drink up to 500 mL of water prior to the first IM vaccination.

Other: Oral Water Hydration

Usual Care

NO INTERVENTION

Subjects will receive usual care prior to the first IM vaccination. No water or food will be offered.

Interventions

Oral Water Hydration OTHER

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).

Oral Water Hydration

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Centers for Disease Control and Prevention: collaborator
• Boston University: collaborator

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (6)

• 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.

  PMID: 9080932 BACKGROUND

• 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.

  PMID: 21293327 BACKGROUND

• 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.

  PMID: 18451756 BACKGROUND

• 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.

  PMID: 15157261 BACKGROUND

• 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.

  PMID: 17655598 BACKGROUND

• 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.

  PMID: 12239256 BACKGROUND

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alex R Kemper, MD, MPH, MS

  Duke University

  PRINCIPAL INVESTIGATOR

• Elizabeth D Barnett, MD

  Boston University

  PRINCIPAL INVESTIGATOR

• Theresa Harrington, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 2, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 7, 2016

Record last verified: 2016-06

Locations

US (2)