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
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhagic Shock||Drug: Premarin IV Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
One time dose of placebo.
Other Name: Infuvite Multivitamin
- 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.
- 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.
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
|United States, Texas|
|Dallas, Texas, United States, 75235|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|Study Director:||Rob Schmickers||University of Washington|