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Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen-Traumatic Hemorrhagic Shock (RESCUE - Shock) (RESCUE-Shock)

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ClinicalTrials.gov Identifier: NCT00973102
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : March 19, 2020
Last Update Posted : March 19, 2020
Sponsor:
Collaborators:
University of Washington
Resuscitation Outcomes Consortium
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
Based on encouraging results from animal studies, the investigators hypothesize that early administration of IV Premarin® in patients with hemorrhagic shock will safely reduce secondary injury, and improve survival.

Condition or disease Intervention/treatment Phase
Hemorrhagic Shock Drug: Premarin IV Drug: Placebo Phase 2

Detailed Description:

Annually in the United States, approximately 30 million people require treatment for traumatic injuries in emergency departments. Two million of these patients require hospitalization, with several hundred thousand ultimately dying, often due to extreme blood loss. Importantly, these traumatic injuries are the leading cause of death and disability for children and young adults under the age of 44, with the total cost of trauma in the U.S. approaching $260 billion each year.

Despite advances in pre-hospital care, early resuscitation, surgical interventions and intensive care monitoring aimed at the primary traumatic injury, many survivors never recover. A significant cause of this mortality and morbidity is thought due to potentially preventable secondary injury, namely oxidant injury, inflammation, and apoptosis beginning in the first few hours after the severe traumatic event.

In spite of the current bleak outlook for many of these patients, a series of animal investigations have uncovered a promising solution to the problem of the secondary injury seen in hemorrhagic shock and other similar processes, namely the early administration of estrogen, a strong anti-oxidant, anti-inflammatory and anti-apoptotic compound.

Based on encouraging results from animal studies, the investigators hypothesize that early administration of IV Premarin® in patients with hemorrhagic shock will safely reduce secondary injury, and improve survival.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Resuscitative Endocrinology: (RESCUE - Shock): A Phase II Trial to Evaluate the Effects of Single Dose Intravenous Premarin for Treatment of Patients With Hemorrhagic Shock
Study Start Date : July 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Premarin IV
Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.
Drug: Premarin IV
One time dose of Premarin IV
Other Name: Estrogen IV

Placebo Comparator: Placebo
Patients who were randomized to receive a single dose of 0.5 mg/kg placebo. Due of the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with hemorrhagic shock.
Drug: Placebo
One time dose of placebo.
Other Name: Infuvite Multivitamin




Primary Outcome Measures :
  1. Survival [ Time Frame: 28 Days ]
    Survival is defined as the number of patients who were discharged from the hospital alive prior to 28 days post injury or the number of patients still alive in the hospital 28 days post injury. The trial examines the rate of enrolled patients on each arm who survived to 28 days.


Secondary Outcome Measures :
  1. Acute Respiratory Distress Syndrome (ARDS) Free Survival [ Time Frame: 28 days ]
    ARDS is a life-threatening condition characterized by inflammation of the lungs. The trial measures the number of days alive and without ARDS within 28 days post injury. Patients who die within 28 days are given value of 0, similarly, patients who live 28 days but have ARDS for all 28 days. A higher score (greater days) indicates better prognosis. Exudative stage is 0-6 days, proliferative stage is 7-10 days, Fibrotic stage is >10-14 days.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age≥ 18 yrs or < 50 yrs
  2. Blunt or penetrating trauma leading to presumed hemorrhagic shock
  3. Pre-hospital or ED systolic blood pressure < 90
  4. Receiving medical treatment in the Emergency Department (ED) of Parkland Hospital or Baylor University Medical Center Emergency Department, Level I Trauma Centers in Dallas, Texas

Exclusion Criteria:

  1. Those who would receive the study drug > 120 minutes after the traumatic event
  2. Time of injury is unknown
  3. Known indication for IV estrogen
  4. Known contraindication for estrogen
  5. Estimated age <18 or > 50 years
  6. Cardiopulmonary Resuscitation (CPR) prior to randomization
  7. Known incarceration
  8. Severe hypothermia (suspected T < 28° C)
  9. Drowning or asphyxia due to hanging
  10. Burns total body surface area (TBSA) > 20%
  11. Isolated penetrating injury to the head
  12. Known inclusion in another interventional trial related to this traumatic event prior to randomization
  13. Known legal do not resuscitate (DNR) orders in place prior to randomization
  14. Recognized spinal cord injury prior to study drug administration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973102


Locations
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United States, Texas
Parkland Hospital
Dallas, Texas, United States, 75235
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
University of Texas Southwestern Medical Center
University of Washington
Resuscitation Outcomes Consortium
Investigators
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Study Director: Rob Schmickers University of Washington
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00973102    
Other Study ID Numbers: RESCUE - Shock
First Posted: September 9, 2009    Key Record Dates
Results First Posted: March 19, 2020
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Shock
Shock, Hemorrhagic
Pathologic Processes
Hemorrhage
Estrogens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs