The purpose of this study is to determine if hypertonic saline with and without dextran can improve overall survival in victims of trauma with shock. Injury and lost blood from trauma can cause your body to be in shock (low blood pressure related to blood loss). This decreased blood flow can lead to organ damage. In order to restore the blood pressure and blood flow, the medics give fluids into the patients' veins as soon as possible. This is called "resuscitation." The resuscitation fluid most commonly used is "isotonic" or one that is the same concentration as the blood. The investigators are trying to determine if infusing a "hypertonic" fluid (or one more concentrated than the blood) can increase the blood pressure and restore blood flow more efficiently. The hypertonic fluids the investigators are using are called hypertonic saline with dextran (HSD) and hypertonic saline (no dextran). Hypertonic saline is a salt solution that is slightly more concentrated than your blood. Dextran is a sugar solution.
Specific Aim: To determine if prehospital administration of 7.5% hypertonic saline /6% Dextran-70 (HSD) OR 7.5% hypertonic saline alone (HS), compared to current standard therapy with normal saline (NS), as an initial resuscitation fluid, affects survival following traumatic injury with hypovolemic shock. Trauma is the leading cause of death among North Americans between the ages of 1 and 44 years. The majority of these deaths result from hypovolemic shock or severe brain injury. Patients in hypovolemic shock develop a state of systemic tissue ischemia then a subsequent reperfusion injury at the time of fluid resuscitation. Conventional resuscitation involves the IV administration of a large volume of isotonic or slightly hypotonic (lactated ringers, LR) solutions beginning in the prehospital setting. Although not conclusive, prior studies have suggested that alternative resuscitation with hypertonic saline (7.5%) solutions may reduce morbidity or mortality in these patients. Furthermore, hypertonic fluids may have specific advantages in the brain-injured patient, as they may aid in the rapid restoration of cerebral perfusion and prevent extravascular fluid sequestration, thereby limiting secondary brain injury. In addition, recent studies have demonstrated that hypertonicity significantly alters the activation of inflammatory cells, an effect that may reduce subsequent organ injury from ischemia-reperfusion and decrease nosocomial infection. The majority of previous clinical trials have focused on the use of HSD. The potential for 7.5% saline alone (HS) to have similar effects has not been well studied. Removal of the dextran component may enhance the anti-inflammatory effects of this solution, which could improve secondary outcomes such as acute respiratory distress syndrome (ARDS), multiple organ failure syndrome (MOFS) and rates of nosocomial infections. This study is a randomized, double-blind, three-arm placebo controlled trial designed to evaluate the clinical outcome of trauma patients with hypovolemic shock, as manifested by prehospital hypotension. Patients will be randomized to a single 250cc IV dose of 7.5% saline in 6% Dextran-70 (HSD), 7.5% saline (HS) or normal saline as the initial fluid for prehospital resuscitation. No additional interventions will occur once the patient is admitted to the hospital. In hospital data collection will last up to 28 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
895
250 cc dose given as a one-time intravenous (IV) bolus in the pre-hospital setting.
250 cc dose given as a one-time IV bolus in the pre-hospital setting.
250 cc dose given as a one-time IV bolus in the pre-hospital setting.
Alabama Resuscitaion Center, University of Alabama
Birmingham, Alabama, United States
UCSD-San Diego Resuscitation Research Center
San Diego, California, United States
Iowa Resuscitation Network, University of Iowa Carver College of Medicine
Iowa City, Iowa, United States
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
Portland, Oregon, United States
The Pittsburgh Resuscitation Network, University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
Dallas, Texas, United States
Seattle-King County Center For Resuscitation Research, University of Washington
Seattle, Washington, United States
Milwaukee Resuscitation Network, Medical College of Wisconsin
Milwaukee, Wisconsin, United States
University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research Institute
Ottawa, Ontario, Canada
Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto
Toronto, Ontario, Canada
28 Day Survival
The day of episode is counted as "Day 0". So for measures using a 28 day period, the maximum value is 29 (i.e. days 0 through 28).
Time frame: 28 days from time of Emergency Department (ED) arrival
Adult Respiratory Distress Syndrome(ARDS)-Free Survival Through Day 28
Absence of diagnosis of Adult Respiratory Distress Syndrome and alive through day 28
Time frame: 28 days from time of ED arrival
Worst Multiple Organ Dysfunction Score (MODS) Mean Through Day 28
Multiple Organ Dysfunction Score is described as: Six organ systems were chosen, and a score of 0-4 allotted for each organ according to function (0 being normal function through to 4 for most severe dysfunction) with a maximum score of 24. The worst score based on available data (missing values were assumed normal) in each 24-hour period is taken for calculation of the aggregate score.
Time frame: 28 days from time of ED arrival
Presence of Nosocomial Infection Through Day 28
Includes one or more nosocomial infections from the following list: pneumonia, blood stream infection, urinary tract infection and wound infection
Time frame: Within 28 days of injury, while hospitalized
Packed Red Blood Cells (PRBC) First 24 Hours
The numbers of units of packed red blood cells transfused in the first 24 hours
Time frame: First 24 hours from the time of 911 call
Total Fluids First 24 Hours
The total amount of IV fluids given in the pre-hospital setting and the hospital setting in the first 24 hours following the time of 911 call
Time frame: First 24 hours from the time of of 911 call
Ventilator-free Days Through Day 28
The number of days beginning with the day of 911 call counted as "Day O" through day 28 that the patient did not require mechanical ventilation
Time frame: Duration of hospital stay through day 28
Days Alive Out of the Intensive Care Unit (ICU) Through Day 28
The number of days the patient is alive and not being cared for in the intensive care unit
Time frame: First 28 days from the time of 911 call
Days Alive Out of the Hospital Through Day 28
The number of days the patient is alive and no longer an inpatient in the hospital through day 28
Time frame: First 28 days from the time of 911 call
Survival at Hospital Discharge
Alive at the time of discharge from the Level One or Two trauma hospital. This did not include disposition from rehabilitation facilities.
Time frame: Duration of hospital stay through to discharge
Zero Units PRBC in First 24 Hours
This is the total number of subjects who received no blood products in the first 24 hours from the time of the 911 call.
Time frame: From the time dispatch received the 911 call to the end of the first 24 hours
Zero Units PRBC and Died in Field or Emergency Department (ED)
This is the total number of subjects who died in the field or the ED from the set of subjects who received no blood products.
Time frame: From the time dispatch received 911 call to the time of death in the field or ED
Zero Units PRBC and Died Within 6 Hours of Admission to the Hospital
This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received no blood products.
Time frame: The first 6 hours from the time of admission to the hospital
Zero Units PRBC and Died Within 28 Days From the Time of the 911 Call
This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received no units of PRBC.
Time frame: From the time dispatch received the 911 call to 28 days
1-9 Units PRBC in First 24 Hours
This is the total number of subjects who received 1 to 9 units of packed red blood cells (PRBC) in the first 24 hours from the time of the 911 call.
Time frame: From the time dispatch received the 911 call to the end of the first 24 hours
1-9 Units PRBC and Died in Field or ED
This is the total number of subjects who received 1 to 9 units of packed red blood cells (PRBC) among the patients who died in the field or the ED.
Time frame: From the time dispatch received 911 call to the time of death in the field or ED
1-9 Units PRBC and Died Within 6 Hours of Admission to the Hospital
This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received 1 to 9 units of packed red blood cells (PRBC).
Time frame: The first 6 hours from the time of admission to the hospital
1-9 Units PRBC and Died Within 28 Days From the Time of the 911 Call
This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received 1 to 9 units of packed red blood cells (PRBC).
Time frame: From the time dispatch received the 911 call to 28 days
Greater Than 10 Units PRBC in First 24 Hours
This is the total number of subjects who received greater than 10 units of packed red blood cells (PRBC) in the first 24 hours from the time of the 911 call.
Time frame: From the time dispatch received the 911 call to the end of the first 24 hours
Greater Than 10 Units PRBC and Died in Field or ED
This is the total number of subjects who died in the field or the ED among the patients who received greater than 10 units of packed red blood cells (PRBC).
Time frame: From the time dispatch received 911 call to the time of death in the field or ED
Greater Than 10 Units PRBC and Died Within 6 Hours of Admission to the Hospital
This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received greater than 10 units of packed red blood cells (PRBC).
Time frame: The first 6 hours from the time of admission to the hospital
Greater Than 10 Units PRBC and Died Within 28 Days From the Time of the 911 Call
This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received greater than 10 units of packed red blood cells (PRBC).
Time frame: From the time dispatch received the 911 call to 28 days
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