PresyncopeNCT02353390
Oral Water Hydration to Prevent Post-Vaccination Presyncope
A study testing Oral Water Hydration in people with Presyncope and Syncope, run by Duke University at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 11 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Presyncope, Syncope
- What is being tested?
- Oral Water Hydration
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,820 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center
Boston, Massachusetts, 02118
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Feasibility and Impact of Implementing an Oral Water Hydration Strategy to Prevent Post-Vaccination Presyncope and Syncope in Adolescents and Young Adults
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.
Read the 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.
- Conditions
- Presyncope, Syncope
- Being tested
- Oral Water Hydration
- Keywords
- presyncope, syncope, adolescent, young adult, immunization, vaccination, water consumption
- Medical subject headings
- Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Water HydrationOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 20 minutes
Secondary outcomes (2)
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.
Measured: 20 minutes
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."
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PresyncopeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Boston University
- Responsible party
- Sponsor
- Investigators
- Alex R Kemper, MD, MPH, MS, Principal investigator, Duke UniversityElizabeth D Barnett, MD, Principal investigator, Boston UniversityTheresa Harrington, MD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353390
- Sponsor's protocol ID
- Pro00060114
- Other IDs
- 200-2012-53663 0005
- Status last verified
- Jun 2016
- First submitted
- 28 Jan 2015
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9080932National 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.
PubMed 21293327Centers 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.
PubMed 18451756Hanson 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.
PubMed 15157261Newman 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.
PubMed 17655598Soteriades 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.
PubMed 12239256
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Impact of Implementing an Oral Water Hydration Strategy to Prevent Post-Vaccination Presyncope and Syncope in Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT02353390
- Acronym / sponsor ID
- Pro00060114
- Conditions
- Presyncope, Syncope
- Keywords
- presyncope, syncope, adolescent, young adult, immunization, vaccination, water consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,820 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Boston University
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Water Hydration | Active comparator | Other: Oral Water HydrationSubjects will be given up to 15 minutes to drink up to 500 mL of water prior to the first IM vaccination. |
| Usual Care | No intervention | –Subjects will receive usual care prior to the first IM vaccination. No water or food will be offered. |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Water HydrationSubjects 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). | Other | Oral Water Hydration |
Primary outcome
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
2 secondary outcomes
Syncope
Time frame: 20 minutes
Alternative Case Definition of Presyncompe
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Background: PubMed 9080932Braun MM, Patriarca PA, Ellenberg SS. Syncope after immunization. Arch Pediatr Adolesc Med. 1997 Mar;151(3):255-9. doi: 10.1001/archpedi.1997.02170400041007.
- Background: PubMed 21293327National 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.
- Background: PubMed 18451756Centers 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.
- Background: PubMed 15157261Hanson 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.
- Background: PubMed 17655598Newman 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.
- Background: PubMed 12239256Soteriades 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex R Kemper, MD, MPH, MS principal investigator
Duke University
Elizabeth D Barnett, MD principal investigator
Boston University
Theresa Harrington, MD principal investigator
Centers for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Water Hydration in people with Presyncope and Syncope, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presyncope (time frame: 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02353390, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2016; AzTrials last refreshed its copy on 6 Nov 2026.