Trial Outcomes & Findings for Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen-Traumatic Hemorrhagic Shock (RESCUE - Shock) (NCT NCT00973102)
NCT ID: NCT00973102
Last Updated: 2020-03-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
28 Days
Results posted on
2020-03-19
Participant Flow
Clinical sites enrolled men and women age 18 to 55 who experienced hemorrhagic shock in the emergency medical services (EMS) setting between September 2009 and January 2012.
Participant milestones
| Measure |
Premarin IV
Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.
Premarin IV: One time dose of Premarin IV
|
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.
Placebo: One time dose of placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Premarin IV
Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.
Premarin IV: One time dose of Premarin IV
|
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.
Placebo: One time dose of placebo.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Prisoner
|
0
|
1
|
Baseline Characteristics
Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen-Traumatic Hemorrhagic Shock (RESCUE - Shock)
Baseline characteristics by cohort
| Measure |
Premarin IV
n=23 Participants
Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.
Premarin IV: One time dose of Premarin IV
|
Placebo
n=25 Participants
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.
Placebo: One time dose of placebo.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.9 years
n=5 Participants
|
32.2 years
n=7 Participants
|
33.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
25 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 DaysSurvival 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.
Outcome measures
| Measure |
Premarin IV
n=23 Participants
Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.
Premarin IV: One time dose of Premarin IV
|
Placebo
n=25 Participants
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.
Placebo: One time dose of placebo.
|
|---|---|---|
|
Survival
|
16 participants
|
21 participants
|
SECONDARY outcome
Timeframe: 28 daysARDS 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.
Outcome measures
| Measure |
Premarin IV
n=23 Participants
Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.
Premarin IV: One time dose of Premarin IV
|
Placebo
n=25 Participants
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.
Placebo: One time dose of placebo.
|
|---|---|---|
|
Acute Respiratory Distress Syndrome (ARDS) Free Survival
|
3.00 units on a scale
Standard Deviation 3.46
|
3.33 units on a scale
Standard Deviation 3.01
|
Adverse Events
Premarin IV
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Premarin IV
n=23 participants at risk
Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.
Premarin IV: One time dose of Premarin IV
|
Placebo
n=25 participants at risk
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.
Placebo: One time dose of placebo.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Bloodstream
|
4.3%
1/23 • Number of events 1
|
0.00%
0/25
|
|
Infections and infestations
Urinary tract infection
|
4.3%
1/23 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Line infection
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Wound infection
|
8.7%
2/23 • Number of events 2
|
16.0%
4/25 • Number of events 4
|
|
Infections and infestations
Intra-abdominal abscess
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Pseudomembranous colitis
|
4.3%
1/23 • Number of events 1
|
0.00%
0/25
|
|
Vascular disorders
Pulmonary embolus
|
4.3%
1/23 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
8.7%
2/23 • Number of events 2
|
0.00%
0/25
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place