Injuries, Shock, Traumatic
Conditions
Brief summary
Hypothesis: We hypothesize that resuscitation regimens which minimize the total volume of resuscitation fluid, while restoring organ perfusion, will lead to lower morbidity and mortality in critically ill patients following trauma.
Interventions
DRUGnormal saline control
no vasopressin added to bolus or 5 hour continuous infusion
DRUGvasopressin
vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be eligible for enrollment in the study, a patient must meet all of the follow criteria at assessment: * Patient is a male or female patient presumed to be at least 18 years of age; * Patient has a systolic blood pressure \< 90 mmHg; * Patient has clinical evidence of acute traumatic injury; * Infusion of study drug must start within one hour following SBP (systolic blood pressure) \< 90 mmHg
Exclusion criteria
A patient meeting any one of the following criteria at hospital assessment is not eligible for enrollment: * Patient is admitted to one of the study hospitals' Emergency Department greater than six hours after injury; * Patient has received greater than 4 liters fluid since time of injury; * Patient is enrolled in another shock trial; * Patient is asystolic or requires CPR (cardiopulmonary resucitation) prior to randomization; * Female patient is pregnant by report or suspicion; * Patient has known Do Not Resuscitate orders or visible/identifiable method of objection to participation (e.g., exclusion bracelet);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Endpoint of This Study Will be Day 30 Mortality. | 30 days | Survival of a traumatic injury subject to at least 30 days after admission to the emergency room. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Vasopressin After Trauma. | 12 hours | Level of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm |
Countries
United States
Participant flow
Recruitment details
recruitment location - Emergency room Feb 2007- Feb 2009
Pre-assignment details
clinical indication prohibiting potential use of vasopressin.
Participants by arm
| Arm | Count |
|---|---|
| Normal Saline bolus of NS followed by continuous infusion of NS, no vasopressin added
normal saline control : no vasopressin added to bolus or 5 hour continuous infusion | 41 |
| Vasopressin Vasopressin
vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours | 40 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | subject identified as detainee | 1 | 0 |
| Overall Study | subject identified as Jehovah's witness | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Vasopressin | Normal Saline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 35 Participants | 70 Participants |
| Age, Continuous | 48.1 years STANDARD_DEVIATION 19.8 | 46.3 years STANDARD_DEVIATION 26.1 | 47.1 years STANDARD_DEVIATION 20.4 |
| Region of Enrollment United States | 40 participants | 41 participants | 81 participants |
| Sex: Female, Male Female | 11 Participants | 7 Participants | 18 Participants |
| Sex: Female, Male Male | 29 Participants | 34 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 37 / 41 | 35 / 40 |
| serious Total, serious adverse events | 19 / 41 | 20 / 40 |
Outcome results
Primary
The Primary Endpoint of This Study Will be Day 30 Mortality.
Survival of a traumatic injury subject to at least 30 days after admission to the emergency room.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Normal Saline | The Primary Endpoint of This Study Will be Day 30 Mortality. | 11 Participants |
| Vasopressin | The Primary Endpoint of This Study Will be Day 30 Mortality. | 13 Participants |
Secondary
Level of Vasopressin After Trauma.
Level of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm
Time frame: 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Saline | Level of Vasopressin After Trauma. | 25 pg/ml | Standard Deviation 37 |