EpiDOSE is an acronym for the Epinephrine Dose: Optimal versus Standard Evaluation clinical trial.
It is a randomized controlled trial initiated by Dr. Paul Dorian and Dr. Steve Lin at St. Michael’s Hospital, in collaboration with physicians and paramedics in Ontario and British Columbia. The study is funded by the Canadian Institutes of Health Research, Canada’s federal funding source for health research. Meet our team here.
The goal of EpiDOSE is to improve patient outcomes after cardiac arrest. We will test how effective a lower dose of epinephrine is compared to a standard dose of epinephrine on survival to hospital discharge in adults who experience an out-of-hospital cardiac arrest. The current usual dose (or standard dose) that most patients receive is 1mg of epinephrine every 3 to 5 minutes until return of spontaneous circulation or termination of resuscitation, which, on average is up to 6mg total. The lower dose used in the study is up to 2mg total. Currently, the best total dose of epinephrine during an out-of-hospital cardiac arrest is unknown.
Study enrollment will begin in Fall 2021 and last for approximately 5 years.
The optimal dose of epinephrine during an out-of-hospital cardiac arrest is not known. Previous research has suggested that the standard total dose of epinephrine may be too high and that a lower total dosage may be more beneficial for long-term survival. A randomized controlled trial is needed to determine if a lower total dosage is indeed more beneficial for adults who experience an out-of-hospital cardiac arrest.
Emergency medical services in British Columbia, Saskatchewan and Ontario, including Peel, Halton, Toronto, and Ottawa.
The best dose of epinephrine during an out-of-hospital cardiac arrest is not known. Previous research has suggested that the standard total dose of epinephrine may be too high and that a lower total dosage may be more beneficial for long-term survival. A randomized controlled trial is needed to determine if a lower total dosage is indeed more beneficial for adults who experience an out-of-hospital cardiac arrest.
In most forms of research, consent is required before human participants can be enrolled. One of the considerations for EpiDOSE however, is that it’s not possible to obtain consent from a patient who has suffered an out-of-hospital cardiac arrest. Under extenuating circumstances like emergency care, Research Ethics Boards may allow research to be performed with waived consent. Conducting a research study with a waiver of consent requires the study to follow strict guidelines, all of which have been satisfied in EpiDOSE.
Cardiac arrest continues to be an important health issue in Canada with low survival rates. As a treatment, the International Liaison Committee on Resuscitation (ILCOR) currently recommends epinephrine during cardiac arrest resuscitation. Previous research has shown that epinephrine increases short-term cardiac resuscitation rates, but epinephrine’s benefit on long-term survival is limited, and recent studies have suggested it may even be harmful. Some research suggests a lower dose of epinephrine may lead to better outcomes, so EpiDOSE was designed in the hopes that we can gather more information, to inform the decisions we make when using epinephrine.
Yes, our study was approved by the Sunnybrook Research Ethics Board. This means that EpiDOSE is acting within the guidance of the Tri-Council Policy Statement for Ethical Conduct for Research Involving Humans. It is a joint policy made by Canada’s three federal research agencies and provides ethical guidance and review for research involving humans.
Currently, the optimal dose of epinephrine for out-of-hospital cardiac arrest patients is not known. There has been some research that has suggested that a lower dose of epinephrine may improve long-term outcomes for patients. As a result, we wanted to scientifically determine whether a lower dose of epinephrine is more beneficial for adults who experience an out-of-hospital cardiac arrest.
Individuals who experience cardiac arrest have sudden loss of consciousness. Therefore, it is not possible to obtain consent before performing emergency care procedures. However, following all treatment, we strive to inform our patients/patient families about the trial as soon as possible.
The data controller for this trial is currently The Applied Health Research Centre (AHRC) at St. Michael’s Hospital, though this may change as the trial progresses. Information being collected includes basic demographical information about you, information about the cardiac arrest, hospital information, and information about what happened after leaving the hospital. All data is stored safely, according to the security requirements of administrative data providers.
Yes, during the trial, all the information about you was de-identified, and 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.
We understand that you may not want to participate in the follow-up portion of the study. If you wish to withdraw from the trial follow-up, please contact us at epidose@unityhealth.to .