Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma
Condition: Blunt Trauma; Penetrating Wound; Hemorrhagic Shock
MeSH terms: Shock; Shock, Hemorrhagic; Wounds and Injuries; Wounds, Penetrating
Intervention: 0.9% Sodium Chloride 250 mL bolus; 0.9% Sodium Chloride 2000 mL bolus
Intervention description: Emergency Medicine Systems (EMS) agencies and in-hospital providers will be given the option to utilize either systolic blood pressure (SBP) or radial pulse as the endpoint for fluid resuscitation to patients randomized to the experimental group. Patients will receive a 250 ml bolus of normal saline (NS) only if the SBP is less than 70 mmHg or the radial pulse is not palpable. If the SBP is greater than or equal to 70 mmHg or the radial pulse is palpable, NS will be given to keep the vein open. The presence or absence of a radial pulse or the SBP will be documented before and after each bolus. The study will continue repeating the randomization procedure using only 250 ml bags of NS until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first.; Emergency Medicine Systems (EMS) personnel and in-hospital providers will utilize the systolic blood pressure SBP as the endpoint for delivering fluid resuscitation to patients randomized to the control group. If the SBP is equal to or less than 90 mmHg, the EMS personnel will start infusing a 1000 ml bolus of normal saline (NS) and will continue using only 1000 ml bags of NS as needed. If the total fluid resuscitation exceeds 2 liters, fluid will be stopped when the SBP exceeds 110 mmHg and restarted as necessary to maintain a goal SBP of 110 mmHg. The fluid will be given as rapidly as possible. This fluid resuscitation protocol will continue until either 2 hours after hospital arrival or until control of hemorrhage is achieved whichever occurs first.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 192.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: fluid volume resuscitation; trauma; hemorrhagic shock

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