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As a Learning Health System, Denver Health creates, conducts and applies research to influence and improve the care we give to our patients. Our researchers and clinical care teams collaborate daily in the search for new diagnostic and technology-driven care that improves outcomes.
Patient consent is a fundamental tenet of medical research. Yet, consent requires the patient to be fully aware of the risks and benefits. In life-threatening emergencies, patients are often unconscious, confused or in serious distress, which limits their ability to provide consent. Consequently, identifying the best care for life-threatening conditions requires a different type of consent, which occurs through a process called “Exception from Informed Consent” (EFIC).
In an EFIC study, researchers spend months consulting with their patient community to explain the risks and benefits of the study, and, ultimately, to obtain consent for it. Once the patient community for a study has been consulted, doctors can then decide to include eligible patients in the study when patients cannot consent for themselves in the moment. Once family arrives or the patient has recovered from their illness, researchers discuss the study with them to get their consent to continue in the study. EFIC studies adhere to a process that is overseen by both the U.S. Food and Drug Administration (FDA) and an independent ethics committee called an institutional review board.
In 2024, Denver Health is conducting several EFIC studies. Please email our Office of Research with any general questions about these studies and feel free to contact the Primary Investigators (PIs) listed below.
The Emergency Department at Denver Health is participating in a national study to evaluate if one of two commonly used sedative medications during emergency intubation improves outcomes for severely ill adult patients. Intubation is a high-risk medical procedure that is done to put a severely ill patient on a breathing machine. One in four of these patients, or 25%, experience serious problems with blood pressure or oxygen levels during this procedure.
Some of the risks of this procedure are related to the sedative medications given to patients to make them sleepy. The two most common sedatives used for intubation are etomidate and ketamine. Both have been used for decades and are approved by the U.S. Food and Drug Administration (FDA). However, it is not known if one drug is better for patients overall, or among patients with specific medical problems.
Denver Health’s participation in this study seeks to help answer these important questions. During this study, if a seriously ill adult patient needs to be put on a breathing machine in the Denver Health Emergency Department, the emergency physician will decide if the patient is eligible for this study. Patients will only be included if the physician determines that both sedative drugs, etomidate and ketamine, are equally effective for that patient. In this case, the choice between the two drugs will be made randomly by the study. For more information on this study, please refer to the trial’s main site or contact Stacy Trent, MD in Denver Health’s emergency department.
When a child suffers a life-threatening illness or accident, Emergency Medical Services is often the first on the scene and the first to preform life-saving medical methods to restore or maintain breathing before the child can get to the hospital. The Pedi-PART study will determine which of the three airway management methods is best when caring for children who are critically ill and need emergency care because they have stopped breathing.
This study will compare three methods that are used every day by emergency medical providers to manage airways and support breathing. The three methods to be compared will be bag-valve mask, endotracheal intubation and a Supraglottic airway, which may also be called an SGA or could be called by a brand-name such as i-gel. In this study, providers will be assigned to use a different device each day. For example, if it is an odd-numbered day, the airway method assigned may be the SGA or i-gel and providers would use that method instead of bag-valve-mask alone or intubation.
For more information on this study, please refer to the trial’s main site or contact Lara Rappaport in Denver Health’s Pediatric Emergency Department and Urgent Care.
What is CAVALIER?
CAlcium and VAsopressin following Injury Early Resuscitation (CAVALIER) Study
The CAlcium and VAsopressin following Injury Early Resuscitation trial, or simply CAVALIER, is a research study that will look at whether giving calcium, vasopressin, or both early in the course of treatment would help severely injured patients that lose a lot of blood survive their injuries.
Normally when a person loses a lot of blood, they may receive calcium, vasopressin or both as part of standard medical care, but not until they arrive at the hospital or are admitted to an intensive care unit (ICU). After a patient is determined to be sick enough to enroll in the study, researchers will do a randomization (like flipping a coin) to determine if the patient will receive a study drug or a placebo (salt water).
For this study, some people who have injuries that caused them to lose a lot of blood will get calcium before arriving at the hospital, vasopressin before going to the ICU, and some people will get both. The other people will get a placebo. A placebo is not a drug but is designed to look like a drug to help compare with the study drugs to learn if the study drug as any real effect. Information from health records for all groups will also be collected as part of the study. Researchers will look at both groups of people and see if one group did better than the other.
The study is “double blinded” which means the study drug and placebo the care team will look identical to remove any bias against the drug. If something were to happen where the care team needs to know which was given, a plan is in place to give them that information quickly.
For this study, researchers will compare these groups to see if one group recovers from their injuries better than the other. Additionally, researchers will compare the group of patients who received both calcium and vasopressin to see if they recover better.
Who will be included?
CAVALIER will enroll adults who are over 18 years old and less than 90 years old who are:
• Severely injured patients that lose a lot of blood (at risk of hemorrhagic shock)
• Being transported to or undergoing emergency surgery at a research site participating in CAVALIER.
Why this research?
Trauma is the leading cause of death and researchers think that providing two commonly used products earlier than typical care as adjuncts to blood products could improve chances of survival.
Why Calcium? Why Vasopressin?
Patients who lose a lot of blood are often given blood or blood components. Patients who receive blood or blood components also receive calcium later in their care, which helps their blood to clot.
Researchers think that giving calcium sooner may be better at lowering the risk of death. When patients lose a lot of blood their blood pressure drops. Drugs called “vasopressors” or “pressors” are given to patients with low blood pressure to “squeeze” their veins to increase blood pressure to a healthy level.
Researchers think giving vasopressin early could improve the chances of recovery in patients who have sustained life threatening injuries with loss of blood.
What are the risks? Are there any benefits?
Patients who have lost a lot of blood often receive calcium, vasopressin, or both. Researchers believe that giving these drugs closer to the time of injury has similar risks to when they are given now. The research could provide information that saves lives.
How are people enrolled in the study?
People who have traumatic injuries and lose a lot of blood (at risk of hemorrhagic shock) who are being transported to a research site participating in CAVALIER and patients who are also undergoing emergent surgery for their injuries may be included in this study.
Normally, researchers must ask a person for their consent before they can be in a study. Because traumatic injuries must be treated right away, there may not be time to get consent. Giving consent for medical research usually means reading information, talking with doctors and nurses, and having time to think about whether to join. A person with traumatic injury is often not able to do these things. Sometimes researchers can talk to the patient’s family to ask for consent. However, in the emergency of traumatic injury, the family is often not around or can’t be found before the injured person must be treated. This study could not be done without special permission to include people before getting consent. This permission is called Exception from Informed Consent, or EFIC. Once the enrolled person is better and can consent or their family arrives at the hospital, the researchers will ask for consent to continue with the study. For more information regarding EFIC, please visit Emergency Research - LITES Network
How do I opt out of the study?
You can opt-out of the study by contacting us using any of the methods below and letting us know that you do not want to participate. Please make sure to give us your name and contact information so that we can get in touch with you. We can provide you with a hypoallergenic silicone bracelet to wear that indicates that you should not be enrolled into the study. Please note that opting out of the study only means that you will not receive calcium or vasopressin as part of the study. Opting out will not prevent you from getting these products as part of your normal care.
For questions or to learn more about this study, please call us at 1-800-664-0557 or email us at CAVALIER@edc.pitt.edu.
The Emergency Department at Denver Health is participating in a national study to evaluate if one of two commonly used sedative medications during emergency intubation improves outcomes for severely ill adult patients. Intubation is a high-risk medical procedure that is done to put a severely ill patient on a breathing machine. One in four of these patients, or 25%, experience serious problems with blood pressure or oxygen levels during this procedure.
Some of the risks of this procedure are related to the sedative medications given to patients to make them sleepy. The two most common sedatives used for intubation are etomidate and ketamine. Both have been used for decades and are approved by the U.S. Food and Drug Administration (FDA). However, it is not known if one drug is better for patients overall, or among patients with specific medical problems.
Denver Health’s participation in this study seeks to help answer these important questions. During this study, if a seriously ill adult patient needs to be put on a breathing machine in the Denver Health Emergency Department, the emergency physician will decide if the patient is eligible for this study. Patients will only be included if the physician determines that both sedative drugs, etomidate and ketamine, are equally effective for that patient. In this case, the choice between the two drugs will be made randomly by the study. For more information on this study, please refer to the trial’s main site or contact Stacy Trent, MD in Denver Health’s emergency department.
When a child suffers a life-threatening illness or accident, Emergency Medical Services is often the first on the scene and the first to preform life-saving medical methods to restore or maintain breathing before the child can get to the hospital. The Pedi-PART study will determine which of the three airway management methods is best when caring for children who are critically ill and need emergency care because they have stopped breathing.
This study will compare three methods that are used every day by emergency medical providers to manage airways and support breathing. The three methods to be compared will be bag-valve mask, endotracheal intubation and a Supraglottic airway, which may also be called an SGA or could be called by a brand-name such as i-gel. In this study, providers will be assigned to use a different device each day. For example, if it is an odd-numbered day, the airway method assigned may be the SGA or i-gel and providers would use that method instead of bag-valve-mask alone or intubation.
For more information on this study, please refer to the trial’s main site or contact Lara Rappaport in Denver Health’s Pediatric Emergency Department and Urgent Care.
CAlcium and VAsopressin following Injury Early Resuscitation (CAVALIER) Study
The CAlcium and VAsopressin following Injury Early Resuscitation trial, or simply CAVALIER, is a research study that will look at whether giving calcium, vasopressin, or both early in the course of treatment would help severely injured patients that lose a lot of blood survive their injuries.
Normally when a person loses a lot of blood, they may receive calcium, vasopressin or both as part of standard medical care, but not until they arrive at the hospital or are admitted to an intensive care unit (ICU). After a patient is determined to be sick enough to enroll in the study, researchers will do a randomization (like flipping a coin) to determine if the patient will receive a study drug or a placebo (salt water).
For this study, some people who have injuries that caused them to lose a lot of blood will get calcium before arriving at the hospital, vasopressin before going to the ICU, and some people will get both. The other people will get a placebo. A placebo is not a drug but is designed to look like a drug to help compare with the study drugs to learn if the study drug as any real effect. Information from health records for all groups will also be collected as part of the study. Researchers will look at both groups of people and see if one group did better than the other.
The study is “double blinded” which means the study drug and placebo the care team will look identical to remove any bias against the drug. If something were to happen where the care team needs to know which was given, a plan is in place to give them that information quickly.
For this study, researchers will compare these groups to see if one group recovers from their injuries better than the other. Additionally, researchers will compare the group of patients who received both calcium and vasopressin to see if they recover better.
Who will be included?
CAVALIER will enroll adults who are over 18 years old and less than 90 years old who are:
• Severely injured patients that lose a lot of blood (at risk of hemorrhagic shock)
• Being transported to or undergoing emergency surgery at a research site participating in CAVALIER.
Why this research?
Trauma is the leading cause of death and researchers think that providing two commonly used products earlier than typical care as adjuncts to blood products could improve chances of survival.
Why Calcium? Why Vasopressin?
Patients who lose a lot of blood are often given blood or blood components. Patients who receive blood or blood components also receive calcium later in their care, which helps their blood to clot.
Researchers think that giving calcium sooner may be better at lowering the risk of death. When patients lose a lot of blood their blood pressure drops. Drugs called “vasopressors” or “pressors” are given to patients with low blood pressure to “squeeze” their veins to increase blood pressure to a healthy level.
Researchers think giving vasopressin early could improve the chances of recovery in patients who have sustained life threatening injuries with loss of blood.
What are the risks? Are there any benefits?
Patients who have lost a lot of blood often receive calcium, vasopressin, or both. Researchers believe that giving these drugs closer to the time of injury has similar risks to when they are given now. The research could provide information that saves lives.
How are people enrolled in the study?
People who have traumatic injuries and lose a lot of blood (at risk of hemorrhagic shock) who are being transported to a research site participating in CAVALIER and patients who are also undergoing emergent surgery for their injuries may be included in this study.
Normally, researchers must ask a person for their consent before they can be in a study. Because traumatic injuries must be treated right away, there may not be time to get consent. Giving consent for medical research usually means reading information, talking with doctors and nurses, and having time to think about whether to join. A person with traumatic injury is often not able to do these things. Sometimes researchers can talk to the patient’s family to ask for consent. However, in the emergency of traumatic injury, the family is often not around or can’t be found before the injured person must be treated. This study could not be done without special permission to include people before getting consent. This permission is called Exception from Informed Consent, or EFIC. Once the enrolled person is better and can consent or their family arrives at the hospital, the researchers will ask for consent to continue with the study. For more information regarding EFIC, please visit Emergency Research - LITES Network
How do I opt out of the study?
You can opt-out of the study by contacting us using any of the methods below and letting us know that you do not want to participate. Please make sure to give us your name and contact information so that we can get in touch with you. We can provide you with a hypoallergenic silicone bracelet to wear that indicates that you should not be enrolled into the study. Please note that opting out of the study only means that you will not receive calcium or vasopressin as part of the study. Opting out will not prevent you from getting these products as part of your normal care.
For questions or to learn more about this study, please call us at 1-800-664-0557 or email us at CAVALIER@edc.pitt.edu.
