AVERT Shock: Arginine Vasopressin During the Early Resuscitation of Traumatic Shock
Condition: Traumatic Shock
MeSH terms: Diabetes Insipidus; Shock; Shock, Traumatic
Intervention: Vasopressin
Intervention description: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours.
Intervention MeSH terms: Vasopressins; Arginine Vasopressin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: trauma; shock; vasopressin; blood transfusion

Summary:

      Trauma patients, who are transfused with multiple blood products to treat shock due to blood
      loss, frequently develop inappropriately low vasopressin levels. Vasopressin is a hormone
      necessary to maintain an adequate blood pressure and low levels have been associated with the
      need for increased transfusions, vasopressors and additional morbidity. Vasopressin is
      routinely used in the ICU to treat septic shock and other disease processes resulting in
      decreased vasopressin levels and low blood pressure. This study will investigate the
      potential benefit of early vasopressin supplementation during the resuscitation of trauma
      patients and the applicability of using copeptin as a vasopressin biomarker. Trauma patients
      who receive 6 or more units of blood product within 12 hours of arrival will be randomized to
      receive a vasopressin bolus plus infusion or a similar volume of a placebo (normal saline)
      for 48 hours. Serial blood samples will be taken for 5 days post-injury. Clinical and
      demographic data will be recorded prospectively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Trauma patients between the ages of 18 and 65 who require 6 or more units of blood
             product during their initial 12 hours of resuscitation will be considered for
             enrollment.

        Exclusion Criteria:

          -  Patients with a traumatic brain injury requiring neurosurgical operative intervention
             or who have neurologic trauma deemed non-survivable will also be excluded.

          -  Patients with an active coronary syndrome, history of myocardial infarction or
             coronary artery disease will be excluded.

          -  Patients with known renal dysfunction requiring dialysis will be excluded.

          -  Patients who are pregnant will be excluded.

          -  Patients less than 18 years old will be excluded.

          -  Patients who have opted out by bracelet identification or by listing themselves on the
             "Non-Participant" roster.

          -  Patients under the jurisdiction of the department of corrections and considered
             prisoners prior to the initiation of the research intervention will be excluded