Oral Water Hydration to Prevent Post-Vaccination Presyncope

Completed · Not applicable

Conditions studied: Presyncope, Syncope

In brief

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.

Key facts

Study ID

NCT02353390

Run by

Duke University

People needed

1820

Starts

2015-03-01

Expected to finish

2016-06-01

Last updated by the study team

2016-07-07

Who can join

Age: 11 and older, up to 21. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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