Phase 2
N=191
Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma
Blunt Trauma · Penetrating Wound · Hemorrhagic Shock
Bottom Line
View on ClinicalTrials.gov: NCT01411852 ↗Enrolled (actual)
191
Serious AEs
13.6%
Results posted
Oct 2014
Primary outcome: Primary: Total Volume of All Crystalloid Given for Early Resuscitation (Feasibility) — 2.04; 1.04; 1 liters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 0.9% Sodium Chloride 250 mL bolus (Drug); 0.9% Sodium Chloride 2000 mL bolus (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Volume of All Crystalloid Given for Early Resuscitation (Feasibility) |
2.04; 1.04; 1 | — |
| PRIMARY 24 Hour Mortality |
14; 5; 81; 91 | — |
| SECONDARY Number of Ineligible Patients Enrolled at the Time of Randomization |
24; 9 | — |
| SECONDARY Total Fluid Requirement During First 24 Hours |
4.43; 5.61 | — |
| SECONDARY Total Blood Product Requirements in First 24 Hours |
0.84; 1.61 | — |
| SECONDARY Base Deficit on Admission to the Emergency Department (ED) |
6.4; 6.2 | — |
| SECONDARY Hemoglobin on Admission to the Emergency Department |
12.6; 12.3 | — |
| SECONDARY Platelet Value on Admission |
219.5; 239.9 | — |
| SECONDARY International Normalized Ratio (INR) on Admission to the Emergency Department |
1.18; 1.16 | — |
| SECONDARY Hemorrhage Control Procedure Within 2 Hours of ED Arrival |
19; 29 | — |
| SECONDARY Acute Renal Failure Classification Score of "Risk" Without Glomerular Filtration Rate (GFR) |
3; 11 | — |
| SECONDARY Acute Renal Failure Classification Score of "Injury" Without Glomerular Filtration Rate (GFR) |
3; 8 | — |
| SECONDARY Acute Renal Failure Classification Score of "Failure" Without Glomerular Filtration Rate (GFR) |
1; 3 | — |
| SECONDARY Ventilator Free Days Through Day 28 |
23.6; 24.5 | — |
| SECONDARY Days Alive Out of the Intensive Care Unit (ICU) Through Day 28 |
23.0; 23.6 | — |
| SECONDARY Days Alive Out of the Hospital Through Day 28 |
18.6; 18.5 | — |
| SECONDARY Blunt Trauma 24 Hour Mortality |
11; 2; 51; 61 | — |
| SECONDARY Penetrating Trauma 24 Hour Mortality |
3; 3; 30; 29 | — |
| SECONDARY In-hospital Mortality |
15; 8 | — |
Summary
Primary Aim: To determine the feasibility and safety of hypotensive resuscitation for the early treatment of patients with traumatic shock compared to standard fluid resuscitation.
Primary Hypotheses: The null hypothesis regarding feasibility is that hypotensive resuscitation will result in the same volume of early crystalloid (normal saline) fluid administration compared to standard crystalloid resuscitation. The null hypothesis regarding safety is that hypotensive resuscitation will result in the same percent of patients surviving to 24 hours after 911 call received at dispatch compared to standard fluid resuscitation. Early resuscitation is defined as all fluid given until 2 hours after arrival in the Emergency Department or until hemorrhage control is achieved in the hospital, whichever occurs earlier.
Eligibility Criteria
Inclusion Criteria: Included will be those with:
- Blunt or penetrating injury
- Age ≥15yrs or weight ≥50kg if age is unknown
- Prehospital SBP ≤ 90 mmHg
Exclusion Criteria: Excluded will be those with:
- Ground level falls
- Evidence of severe blunt or penetrating head injury with a Glasgow Coma Scale (GCS) ≤ 8
- Bilateral paralysis secondary to suspected spinal cord injury
- Fluid greater than 250ml was given prior to randomization
- Cardiopulmonary resuscitation (CPR) by Emergency Medicine Service (EMS) prior to randomization
- Known prisoners
- Known or suspected pregnancy
- Drowning or asphyxia due to hanging
- Burns over a Total Body Surface Area (TBSA) > 20%
- Time of call received at dispatch to study intervention > 4 hours
Data sourced from ClinicalTrials.gov (NCT01411852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.