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Oral Water Hydration to Prevent Post-Vaccination Presyncope

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353390
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : July 7, 2016
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Boston University
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE January 28, 2015
First Posted Date  ICMJE February 2, 2015
Last Update Posted Date July 7, 2016
Study Start Date  ICMJE March 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2015)
  • Presyncope [ Time Frame: 20 minutes ]
    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
  • 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. [ Time Frame: 20 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2016)
  • Syncope [ Time Frame: 20 minutes ]
    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.
  • Alternative Case Definition of Presyncompe [ Time Frame: 20 minutes ]
    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."
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2015)
Syncope [ Time Frame: 20 minutes ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Water Hydration to Prevent Post-Vaccination Presyncope
Official Title  ICMJE Feasibility and Impact of Implementing an Oral Water Hydration Strategy to Prevent Post-Vaccination Presyncope and Syncope in Adolescents and Young Adults
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Presyncope
  • Syncope
Intervention  ICMJE 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).
Study Arms  ICMJE
  • Active Comparator: Oral Water Hydration
    Subjects will be given up to 15 minutes to drink up to 500 mL of water prior to the first IM vaccination.
    Intervention: Other: Oral Water Hydration
  • No Intervention: Usual Care
    Subjects will receive usual care prior to the first IM vaccination. No water or food will be offered.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2016)
1820
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2015)
1800
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02353390
Other Study ID Numbers  ICMJE Pro00060114
200-2012-53663 0005 ( Other Grant/Funding Number: Centers for Disease Control and Prevention )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • Centers for Disease Control and Prevention
  • Boston University
Investigators  ICMJE
Principal Investigator: 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
PRS Account Duke University
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP