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1
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- The Hypotensive Resuscitation versus Standard Resuscitation Study
(HypoResus)
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2
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- To seek your opinion on the potential involvement of yourself or a
family member in a research study of IV fluids in patients that suffer
traumatic shock from blood loss,
that will be done under Exception From Informed Consent (EFIC) guidelines.
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3
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- Trauma is the leading cause death for persons between the ages of 1 and
44 years.
- It is also among the top 10 causes of death across all age groups.
- Severe bleeding, head and spinal cord injuries, or a combination of
these result in 80% of trauma deaths.
- More than half of trauma deaths occur within the first 12 hours after
the injury.
- The most preventable death after trauma is exsanguinating hemorrhage–severe
bleeding that leads to shock.
- The presence of shock can be detected by a low blood pressure, fast
heart beat, confusion, pale skin, feeling cold
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4
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- Immediate—50% (at scene)
- Massive brain or spinal injury, cardiovascular event
- Early—30% (within first 24-48 hours)
- Severe brain injury, shock due to blood loss from torso trauma
- Late—20% (days to weeks)
- Multiple organ failure and overwhelming infection
- Influenced by inadequate early resuscitation or care
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5
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6
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- Traditional treatment for shock related to
severe blood loss is aggressive intravenous
(IV) fluid administration.
- The purpose is to attempt to restore circulating
blood volume and an adequate blood pressure.
- Fluids used in the field are typically either
normal saline (salt water solution) or Lactated
Ringer’s solution (balanced solution); also referred to as
“crystalloids.”
- This treatment method is currently endorsed by the American College of
Surgeons Committee on Trauma.
- Current guideline is to give trauma patients with shock two or more liters
of fluid.
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7
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- Over the last 20 years, the practice of giving a high volume of fluids
for shock has come under some question.
- Clinical and basic science literature does not support this practice.
- There is growing evidence that early aggressive fluid resuscitation
with crystalloid-based fluids is associated with a variety of
complications.
- Both human and animal studies have shown the benefit of delayed and
minimal fluid resuscitation until severe bleeding has been controlled.
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8
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- Human trials and observational studies have compared early aggressive
fluid administration to either delayed fluid administration or minimal
fluid administration.
- Some of this research has come from the military conflicts in Iraq and
Afghanistan.
- One study compared standard fluid administration to no fluids until
patients arrived in the operating room.
- Patients with delayed fluids had a higher survival rate and fewer
complications than those with standard fluids.
- Another similar study was conducted in the hospital setting.
- In this case, survival was the same in both groups.
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9
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- Two other studies compared fluid administration to no fluids in the
field.
- One found that the practice of fluids given in the field was associated
with a significant increase in the risk of death.
- Another compared trauma patients transported by EMS to those
transported by private vehicles in Los Angeles.
- Despite similar injuries, the outcome was much better in those
transported by private vehicles.
- The authors hypothesized that delays in transportation and IV fluids in
the field contribute to increased death.
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10
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- When internal bleeding occurs, blood clots form.
- It is the body’s attempt to stop the flow of blood.
- Similar to plugging a hole in a leaking hose.
- The theory is, giving these patients large amounts of fluids dilutes the
blood (minimizing the ability to clot) and “pops” open the plugged
holes.
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11
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- Neither early aggressive administration of fluids in the field, nor
minimal or no fluid administration has proven to be superior.
- Given that the current standard of care may be harmful to trauma
patients, a more comprehensive study is both ethical and needed.
- It will be important to ultimately determine which strategy for the
treatment of severe bleeding is best for trauma patients.
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12
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- The primary aim of the trial will be to:
- To determine the feasibility and safety of minimal fluid administration
for the early treatment of patients with traumatic shock, compared to standard
fluid administration.
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13
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14
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- Randomized controlled trial (a common method used in clinical research).
- A sealed container will have either two small bags of normal saline or
one large bag of normal saline
- EMS personnel will not be able to see (“blinded”) the contents of the
containers until it is open.
- If it contains a large bag, the patient will receive high amounts of
fluid administration.
- If small bags, patient will receive a minimal amount of fluid.
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15
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16
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- Will be provided if desired.
- A “No Study” bracelet will be provided for those who request one.
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17
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- Will be done as soon as possible after enrollment, and will allow for an
opportunity to withdraw from further participation.
- Consent is obtained for the continued review of your medical record, and
only related to the current admission.
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18
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- The study will be monitored by:
- Data Safety Monitoring Board (DSMB)—an independent group
- Institutional Review Board (IRB)
- Food & Drug Administration (FDA)
- National Institutes of Health (NIH)
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19
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- A federal regulation (21 CFR 50.24), allows certain studies that meet
the following criteria to use this exception:
- Patients’ lives must be at risk.
- Available treatments are not satisfactory.
- Patients are unable to give consent.
- Potential risks are reasonable.
- Participation in the research could provide a direct benefit (increased
survival) to the patient.
- The research could not be carried out practically without this
exception.
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20
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- Require community input and commentary for the proposed research.
- Public disclosure
- Community consultation
- Eligible patients for this study will require immediate resuscitation,
since without intervention, patients in shock face imminent death.
- Traditional informed consent is impossible because:
- Patients with severe traumatic injury are unconscious, or in shock and not capable of
providing consent.
- Resuscitation has to be started immediately, and next of kin may not be
immediately available, or are likely to be too distraught to understand
an explanation of the study.
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21
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22
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23
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24
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25
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- Three basic strategies (Haddon)
- Education and persuasion
- e.g., safety messages, drivers
education
- Legal regulation of behavior
- e.g., using drugs and/or alcohol
- Automatic protection
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26
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27
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28
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29
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30
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31
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- Accessed by dialing 9-1-1
- Dual ALS system
- First Response (4-6 minutes)
- Fire ALS Engine, Truck or Rescue
- One or more paramedics
- Transporting Ambulance (within 8 minutes)
- Aeromedical system (400 scene calls/year)
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32
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33
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34
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- Trauma Team
- Trauma surgeon
- Emergency physician
- Anesthesiologist
- Trauma nurse
- Others
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Notes
