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

NCT01611935 | Completed Phase 2 Results DMC

• 1 other identifier: 811293
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Shock

Keywords

trauma; shock; vasopressin; blood transfusion

Outcome Measures

Primary Outcomes (1)

• Number of Blood Products Transfused

  Cumulative number of units of blood products, including packed red blood cells, plasma and platelets measured in liters

  48 hours following the initiation of therapy

Secondary Outcomes (2)

• Need for Vasopressor Requirement Vasopressor Requirement

  48 hours following the initiation of therapy

• Total Number of Complications

  30 days post injury

Study Arms (2)

Vasopressin

ACTIVE COMPARATOR

Vasopressin will be given as an initial bolus (4 Units) followed by an infusion titrated between 0 units/min to 0.04 units per min to maintain a mean arterial blood pressure greater than or equal to 65 mmHg

Drug: Vasopressin

Normal Saline

PLACEBO COMPARATOR

An initial bolus of normal saline will be given (10 cc) and an infusion of 0.1 ml per minute will be started and titrated down in as the mean arterial blood pressure reaches 65 mmHg or more.

Drug: Vasopressin

Interventions

Vasopressin DRUG

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.

Normal Saline; Vasopressin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Trauma Research Institute: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Hospital at the Unversity of Pennyslvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Sims CA, Holena D, Kim P, Pascual J, Smith B, Martin N, Seamon M, Shiroff A, Raza S, Kaplan L, Grill E, Zimmerman N, Mason C, Abella B, Reilly P. Effect of Low-Dose Supplementation of Arginine Vasopressin on Need for Blood Product Transfusions in Patients With Trauma and Hemorrhagic Shock: A Randomized Clinical Trial. JAMA Surg. 2019 Nov 1;154(11):994-1003. doi: 10.1001/jamasurg.2019.2884.

  PMID: 31461138 DERIVED

MeSH Terms

Conditions

Shock, Traumatic; Wounds and Injuries; Shock; Diabetes Insipidus

Interventions

Vasopressins

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Dr. Carrie Sims
• Organization: University of Pennsylvania

carrie.sims@uphs.upenn.edu

215-588-5154

Study Officials

• Carrie A Sims, MD, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 5, 2012
• Study Start: May 1, 2013
• Primary Completion: September 6, 2016
• Study Completion: September 6, 2016
• Last Updated: May 21, 2019
• Results First Posted: May 21, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)