The UT Health Science Center at San Antonio Institutional Review Board will decide whether or not
to allow University Hospital to participate in this study (Low Dose Vasopressin trial) based on
We are interested in having people from the following counties in Texas participate
in this survey. These counties represent Trauma Area P.
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What is the purpose of this study?
To evaluate the effectiveness of Vasopressin in treating patients suffering from shock after a traumatic injury.
What is shock?
Shock can occur when there is massive loss of blood and a dangerously low blood pressure. When shock occurs internal organs don't receive enough oxygen and have difficulty functioning. Death due to shock 30-50%.
Why is this study important?
To try and improve the survival of patients during and after shock.
To better understand the impact Vasopressin has on the treatment and management of patients in shock following severe injuries.
What is the current standard of care?
In the helicopter patients routinely receive:
Fluids (salt water)
Medications
Upon arrival to the hospital patients routinely receive:
Fluids (salt water)
Blood products
Medication
Surgery
What are the standard of care limitations?
Excessive fluids and blood products can cause:
Respiratory failure
Severe swelling of the brain, extremities, and abdomen resulting in possible tissue damage
Bleeding and clotting disorders
Infections
What is Vasopressin(r)?
Vasopressin is approved by the U.S. Food and Drug Administration (FDA) for patients with metabolic disorders such as diabetes insipidus (extreme thirst and frequent urination) and abdominal distention (bloating) after surgery.
Vasopressin is commonly used for the treatment of other disorders not currently approved by the FDA. Vasopressin is recognized by the American Heart Association for its use in the management of patients in cardiac arrest and is commonly used to treat patients who are in shock. For the purpose of this study, we will be administering Vasopressin in the treatment of shock. The dose of Vasopressin to be used in this study is lower than what is given to patients in cardiac arrest or in patients with low blood pressure in the intensive care unit.
How is this study designed?
Severely injured trauma patients determined to be in shock, (blood pressure less than or equal to 90) before arriving, upon arrival or for up to six hours after arrival will be randomized (assigned by chance, like flipping of a coin) to receive either Vasopressin (experimental group) or Placebo (salt water solution with no active medication) in addition to standard of care. Subjects will have an equal chance of receiving either Vasopressin or salt water. This is a double-blinded study which means neither the subject nor the study doctor will know which medication is being given. However, the study doctor can find out which treatment is being given in the case of a medical emergency.
How long will the study last?
The study will be conducted for approximately two years
Individual participation in this study will last no more than 30 days.
Who will be included in the study?
Patients who are severely injured and at-risk of dying will be included in this study. They must be at least 18 years old and in shock.
Who will be excluded from the study?
Patients who will not be enrolled in the study include those who:
Are obviously pregnant
Have "unsurvivable" injuries
Require CPR
Have known orders not to resuscitate
What are the potential benefits of Vasopressin?
There is the potential to decrease the chance of developing side effects due to large amounts of fluid increase and increase the chance for survival.
What are the potential risks of Vasopressin?
The risks of Vasopressin are usually associated with the amount of Vasopressin given.
Side effects (risks) that have been reported in patients receiving Vasopressin include:
paleness
throbbing headache
chest discomfort
irregular heart beat
heart attack
shaky feeling
shakes
dizziness
increase urine output
unforeseen happenings
abdominal (stomach) cramps
passage of gas
nausea
vomiting
The exact percentage of patients experiencing these side effects is not known.
How will consent be obtained?
In most if not all cases patients will not be able to provide informed consent to be in this study because of their injuries. Patients eligible for this study will be enrolled using the exception from informed consent.
What is an exception from informed consent?
It is including people in research without first having their agreement or consent. Usually, only people who give their consent or whose next of kin give consent, are included in research. An exception from the informed consent requirement may be granted in emergency situations making is possible to conduct research even when consent is not possible due to the nature of the patient's injuries. Regulations established by the federal government specify the conditions under which research can be done with an exception from consent.
What if patients don't want to participate in this study?
Patients, and their legally authorized representatives or family members, will be notified at the earliest opportunity. A patient may withdraw or be withdrawn from the study at any time. Those who do not want to participate in the study can wear a special bracelet to exclude themselves. Contact 210-567-3623.
If this study is approved, the study will be registered on the ClinicalTrials.Gov website (http://www.clinicaltrials.gov).
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