Contact:
Leni Kirkman - University Health System - 210-358-2335
Will Sansom - UT Health Science Center - 210-567-8570
New trauma trial aims to improve survival of patients in shock
Researchers seeking community input on exception to informed consent
(SAN ANTONIO - March 30, 2006)
What are your odds of surviving a serious traumatic injury? Not good if your body goes into shock. In fact, a third to a half of all trauma patients who go into shock die, and trauma is the leading cause of death in all Americans under the age of 45. Finding a better way to treat patients in shock is the goal of a study to be conducted by UT Health Science Center at San Antonio (UTHSC) surgeons at the Level I trauma center at University Hospital.
Ten meetings, starting the week of April 3, will enable the public to learn about the Low Dose Vasopressin Trauma Trial and an exception to informed consent needed to conduct this study with patients in shock.
Sponsored by the U.S. Navy, the study will involve approximately 500 shock patients over a 2-3 year period. Participants will be randomized to receive either low dose Vasopressin or the current standard of care (intravenous saline) while they are en route to the trauma center or immediately upon arrival.
Shock causes the patient's blood pressure to become dangerously low and the lack of blood-carrying oxygen to the body's organs can cause them to have difficulty functioning and potentially stop working. Currently, patients in shock immediately receive saline solution. Once at the hospital they may also receive additional medication, blood products and/or go to the operating room. The delivery of excessive fluids and blood products can cause respiratory failure; severe swelling and tissue damage in the brain, abdomen, arms and legs; bleeding and clotting disorders; and infections. The goal of the Vasopressin study is to better understand how to reduce these complications and related deaths.
Vasopressin is a drug approved by the Food and Drug Administration (FDA) for patients with Diabetes Insipidus (extreme thirst and frequent urination) and for patients with abdominal swelling after surgery. It is also commonly used for other problems not currently approved by the FDA. These "off label" uses include treatment for heart attack patients and as an alternative drug for patients in shock. Vasopressin has been shown in previous studies to decrease the amount of fluid required to treat shock, so giving it to shock patients rapidly may decrease the likelihood of side effects from excessive fluids and may potentially increase survivability.
Because severely injured patients enrolled in the trial will be unable to give informed consent prior to enrollment, the study will use a provision for an exception from informed consent requirements in accordance with federal regulations (21 CFR 50.24). 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. If a patient is withdrawn from the study, they will continue to receive treatment for their injuries and the quality of care will not be impacted. This federal regulation allows the UTHSC Institutional Review Board (IRB) to approve a clinical trial without requiring informed patient consent provided specific criteria are met. These criteria include:
- Patients must be in a life-threatening situation
- The experimental treatment must offer patients the potential for direct clinical benefit in the form of increased survival
- The risks are reasonable
- Without an exception from informed consent, the research could not be conducted
