During the cardiac arrest event, you or your family member were included in our research study called EpiDOSE. EpiDOSE is a study to test if a lower dose of epinephrine has more benefits for patients compared to the current standard dose of epinephrine which it typically administered during CPR. At the time of your cardiac arrest event, paramedics gave either a standard dose or a lower dose of epinephrine and collected data to answer this question. As you were not conscious or breathing when you had your event we could not ask for your permission to collect this data, as a result, this was collected under a waiver of consent (without your permission) to allow us access to your ambulance and hospital records.
For Patients & Families
What is a research study?
Research is a highly controlled and regulated way of discovering new information regarding a particular concern or research problem using the scientific method. Research studies are conducted for the purpose of learning more about behaviours and functions with the ultimate goal of benefitting society.
Why are we doing this study?
Despite knowing that administration of epinephrine is important during an out-of-hospital cardiac arrest the best total dosage of epinephrine is unknown. To answer this question a randomized controlled trial is needed to determine if a lower dosage is more beneficial for adults who experience an out-of-hospital cardiac arrest. The results from this research may change cardiac arrest treatment in Canada and worldwide.
What information are you collecting about me or my family member?
- Basic information about you – including your age and sex
- Information about the cardiac arrest, such as whether or not it was seen by someone, who performed CPR, how many defibrillator shocks were given and what other medications may have been used during treatment
- Hospital information, such as where you were taken in, length of stay and type of location you were discharged to (e.g. home or other care centre)
- Information about what happened after you left the hospital
Why do we need to collect this information?
In order for us to make scientific conclusions from the data, we need to consider all the factors that may have affected your treatment and ultimately your outcome. This allows us to consider whether any outside factors may have influenced the results.
We’re sure you have questions and have tried to answer the most frequent ones below:
If the cardiac arrest event happened in Ontario, you may have received a letter that contains various details about the trial, please refer to the letter for more information. If you have any questions, please contact us at epidose@unityhealth.to.
We hope to enroll almost 4000 people from across Canada including in Vancouver, Ottawa and the Greater Toronto Area over the next few years.
While you may or may not receive any direct benefits from being in this study, results from this project could further medical or scientific knowledge in the area of cardiac arrest research. This could greatly help those who may suffer a cardiac arrest in the future.
Epinephrine is a standard medication used in cardiac arrest. We care deeply about patient safety, so we carefully monitor and record any complications of study treatments. There are no expected additional risks in the low dose group compared to the standard dose group. Epinephrine may cause adverse effects, including inflammation at the injection site if the medication is given into the skin, worsening of the condition of the heart, or reduced blood flow to certain organs such as the heart or brain. In some cases, these events can occur even when epinephrine is not used.
If you do not want to be contacted and wish to withdraw from future data collection (either yourself or on behalf of your family member) you can email us at epidose@unityhealth.to . Withdrawal will not affect the care you or your family member currently receive or will receive in the future.
We sincerely respect your privacy, so the research team only collects the information they need for this study. All patient data that is entered into the EpiDOSE database is de-identified, and have their name replaced by a unique study number. This means that all of your personal health identifiers have been removed from the data so that you cannot be identified personally. Even though the likelihood of you being identified is small, it can never be completely eliminated. To ensure data accuracy some medical records may be accessed by study staff to verify the information collected for the study is correct. With all of this in mind, please note that our team has made sure that the study is up to ethical standards given by the Government of Canada.
If the results of this study are published, your identity will remain confidential. It is expected that the information collected during this study will be used in analyses and will be published/presented to the scientific community at meetings and in journals. When presented all patients will be grouped together to ensure individual patient data remains secure.