AVERT Shock: Arginine Vasopressin During the Early Resuscitation of Traumatic Shock

Completed · Phase 2

Conditions studied: Traumatic Shock

In brief

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.

Key facts

Study ID

NCT01611935

Run by

University of Pennsylvania

People needed

101

Starts

2013-05-01

Expected to finish

2016-09-06

Last updated by the study team

2019-05-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Hospital at the Unversity of Pennyslvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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