Shock, Traumatic
Conditions
Keywords
Trauma, Shock
Brief summary
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.
Detailed description
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.
Interventions
DRUG0.9% normal saline
250 cc dose given as a one-time IV bolus in the pre-hospital setting.
DRUG7.5% hypertonic saline/6% Dextran-70 (HSD)
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
The Institute of Circulatory and Respiratory Health (ICRH)
Defence Research and Development Canada
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Blunt or penetrating trauma * Prehospital Systolic Blood Pressure (SBP) \<= 70;OR * Prehospital SBP 71-90 AND Hear Rate (HR) ≥108 * 15 years of age or older, or 50kg or more if age unknown
Exclusion criteria
* Known or suspected pregnancy * Age younger than 15 or less than 50kg if age unknown * Ongoing prehospital cardiopulmonary resuscitation (CPR) * Administration of more than 2000cc crystalloid or any colloid or blood products * Severe hypothermia (suspected Temperature less than 28 degrees celsius) * Drowning or asphyxia due to hanging * Burns Total Body Surface Area (TBSA) more than 20% * Isolated penetrating injury to the head * Inability to obtain prehospital intravenous access * Time of call received at dispatch to study intervention greater than four hours * Known prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28 Day Survival | 28 days from time of Emergency Department (ED) arrival | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Worst Multiple Organ Dysfunction Score (MODS) Mean Through Day 28 | 28 days from time of ED arrival | 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. |
| Presence of Nosocomial Infection Through Day 28 | Within 28 days of injury, while hospitalized | Includes one or more nosocomial infections from the following list: pneumonia, blood stream infection, urinary tract infection and wound infection |
| Packed Red Blood Cells (PRBC) First 24 Hours | First 24 hours from the time of 911 call | The numbers of units of packed red blood cells transfused in the first 24 hours |
| Total Fluids First 24 Hours | First 24 hours from the time of of 911 call | 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 |
| Ventilator-free Days Through Day 28 | Duration of hospital stay 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 |
| Days Alive Out of the Intensive Care Unit (ICU) Through Day 28 | First 28 days from the time of 911 call | The number of days the patient is alive and not being cared for in the intensive care unit |
| Days Alive Out of the Hospital Through Day 28 | First 28 days from the time of 911 call | The number of days the patient is alive and no longer an inpatient in the hospital through day 28 |
| Survival at Hospital Discharge | Duration of hospital stay through to discharge | Alive at the time of discharge from the Level One or Two trauma hospital. This did not include disposition from rehabilitation facilities. |
| Zero Units PRBC in First 24 Hours | From the time dispatch received the 911 call to the end of the 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. |
| Zero Units PRBC and Died in Field or Emergency Department (ED) | From the time dispatch received 911 call to the time of death in the field or 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. |
| Adult Respiratory Distress Syndrome(ARDS)-Free Survival Through Day 28 | 28 days from time of ED arrival | Absence of diagnosis of Adult Respiratory Distress Syndrome and alive through day 28 |
| Zero Units PRBC and Died Within 28 Days From the Time of the 911 Call | From the time dispatch received the 911 call to 28 days | 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. |
| 1-9 Units PRBC in First 24 Hours | From the time dispatch received the 911 call to the end of the 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. |
| 1-9 Units PRBC and Died in Field or ED | From the time dispatch received 911 call to the time of death in the 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. |
| 1-9 Units PRBC and Died Within 6 Hours of Admission to the Hospital | The first 6 hours from the time 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). |
| 1-9 Units PRBC and Died Within 28 Days From the Time of the 911 Call | From the time dispatch received the 911 call to 28 days | 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). |
| Greater Than 10 Units PRBC in First 24 Hours | From the time dispatch received the 911 call to the end of the 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. |
| Greater Than 10 Units PRBC and Died in Field or ED | From the time dispatch received 911 call to the time of death in the 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). |
| Greater Than 10 Units PRBC and Died Within 6 Hours of Admission to the Hospital | The first 6 hours from the time 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). |
| Greater Than 10 Units PRBC and Died Within 28 Days From the Time of the 911 Call | From the time dispatch received the 911 call to 28 days | 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). |
| Zero Units PRBC and Died Within 6 Hours of Admission to the Hospital | The first 6 hours from the time 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. |
Countries
Canada, United States
Participant flow
Recruitment details
Subjects were enrolled by Emergency Medicine Services (EMS) personnel in the pre-hospital setting based on pre-defined inclusion/exclusion criteria. The first subject was enrolled on May 9, 2006 and the last subject was enrolled on August 25, 2008.
Pre-assignment details
895 subjects were randomized. 852 subjects completed the study. Randomization was performed when the outer study fluid bag wrapper was removed in the presence of a patient. To ensure there was no bias, a secondary intention to treat analysis was also performed which included all randomized patients even if the fluid was not administered.
Participants by arm
| Arm | Count |
|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml | 220 |
| 7.5% Hypertonic Saline (HS) 7.5% hypertonic saline (HS) 250ml dose | 256 |
| 0.9% Normal Saline 0.9% normal saline 250 ml dose as placebo | 376 |
| Total | 852 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 11 | 13 | 19 |
Baseline characteristics
| Characteristic | 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | 7.5% Hypertonic Saline (HS) | 0.9% Normal Saline | Total |
|---|---|---|---|---|
| Age Categorical <=18 years | 13 participants | 13 participants | 23 participants | 49 participants |
| Age Categorical >=65 years | 18 participants | 18 participants | 21 participants | 57 participants |
| Age Categorical Between 18 and 65 years | 188 participants | 225 participants | 332 participants | 745 participants |
| Age Continuous | 37.7 years STANDARD_DEVIATION 17.3 | 36.8 years STANDARD_DEVIATION 16.1 | 36.2 years STANDARD_DEVIATION 16.4 | 36.7 years STANDARD_DEVIATION 16.5 |
| Region of Enrollment Canada | 43 participants | 44 participants | 93 participants | 180 participants |
| Region of Enrollment United States | 177 participants | 212 participants | 283 participants | 672 participants |
| Sex: Female, Male Female | 50 Participants | 51 Participants | 85 Participants | 186 Participants |
| Sex: Female, Male Male | 170 Participants | 205 Participants | 291 Participants | 666 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 220 | 1 / 256 | 1 / 376 |
| serious Total, serious adverse events | 21 / 220 | 25 / 256 | 21 / 376 |
Outcome results
Primary
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
Population: Per protocol, analysis was done on only those subjects who received the study fluid per randomization; this was defined as that the study fluid had been connected to the patient's IV.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | 28 Day Survival | 164 participants |
| 7.5% Hypertonic Saline (HS) | 28 Day Survival | 187 participants |
| 0.9% Normal Saline | 28 Day Survival | 279 participants |
Comparison: The null hypothesis is that there are no differences in the percent of patients who survived to day 28 day between the three groups.p-value: 0.91test for proportions
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | 1-9 Units PRBC and Died in Field or ED | 11 participants |
| 7.5% Hypertonic Saline (HS) | 1-9 Units PRBC and Died in Field or ED | 10 participants |
| 0.9% Normal Saline | 1-9 Units PRBC and Died in Field or ED | 14 participants |
Comparison: The null hypothesis is that there are no differences in the percent of patients who died in Field or ED between the three groups among the patients who received 1-9 units of PRBC.p-value: 0.73test for proportions
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | 1-9 Units PRBC and Died Within 28 Days From the Time of the 911 Call | 19 participants |
| 7.5% Hypertonic Saline (HS) | 1-9 Units PRBC and Died Within 28 Days From the Time of the 911 Call | 24 participants |
| 0.9% Normal Saline | 1-9 Units PRBC and Died Within 28 Days From the Time of the 911 Call | 46 participants |
Comparison: The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received 1-9 units of PRBC.p-value: 0.31test for proportions
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | 1-9 Units PRBC and Died Within 6 Hours of Admission to the Hospital | 12 participants |
| 7.5% Hypertonic Saline (HS) | 1-9 Units PRBC and Died Within 6 Hours of Admission to the Hospital | 17 participants |
| 0.9% Normal Saline | 1-9 Units PRBC and Died Within 6 Hours of Admission to the Hospital | 25 participants |
Comparison: The null hypothesis is that there are no differences in the percent of patients who died within 6 hours of admission to the hospital between the three groups among the patients who received 1-9 units of PRBC.p-value: 0.83test for proportions
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | 1-9 Units PRBC in First 24 Hours | 92 participants |
| 7.5% Hypertonic Saline (HS) | 1-9 Units PRBC in First 24 Hours | 111 participants |
| 0.9% Normal Saline | 1-9 Units PRBC in First 24 Hours | 175 participants |
Comparison: The null hypothesis is that there are no differences in the percent of patients who received 1-9 units PRBC in the first 24 hours between the three groups.p-value: 0.51test for proportions
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Adult Respiratory Distress Syndrome(ARDS)-Free Survival Through Day 28 | 147 participants |
| 7.5% Hypertonic Saline (HS) | Adult Respiratory Distress Syndrome(ARDS)-Free Survival Through Day 28 | 170 participants |
| 0.9% Normal Saline | Adult Respiratory Distress Syndrome(ARDS)-Free Survival Through Day 28 | 246 participants |
Comparison: The null hypothesis is that there are no differences in ARDS-free survival through day 28 between the three groups.p-value: 0.94test for proportions
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Days Alive Out of the Hospital Through Day 28 | 10.3 days | Standard Deviation 10.7 |
| 7.5% Hypertonic Saline (HS) | Days Alive Out of the Hospital Through Day 28 | 10.3 days | Standard Deviation 10.8 |
| 0.9% Normal Saline | Days Alive Out of the Hospital Through Day 28 | 10.1 days | Standard Deviation 10.6 |
Comparison: The null hypothesis is that there are no differences in the average number of Days alive out of the hospital through day 28 between the three groups.p-value: 0.98ANOVA
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Days Alive Out of the Intensive Care Unit (ICU) Through Day 28 | 16.4 days | Standard Deviation 12.3 |
| 7.5% Hypertonic Saline (HS) | Days Alive Out of the Intensive Care Unit (ICU) Through Day 28 | 15.7 days | Standard Deviation 12 |
| 0.9% Normal Saline | Days Alive Out of the Intensive Care Unit (ICU) Through Day 28 | 16 days | Standard Deviation 12.2 |
Comparison: The null hypothesis is that there are no differences in the average number of Days alive out of the ICU through day 28 between the three groups.p-value: 0.82ANOVA
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Greater Than 10 Units PRBC and Died in Field or ED | 0 participants |
| 7.5% Hypertonic Saline (HS) | Greater Than 10 Units PRBC and Died in Field or ED | 0 participants |
| 0.9% Normal Saline | Greater Than 10 Units PRBC and Died in Field or ED | 3 participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Greater Than 10 Units PRBC and Died Within 28 Days From the Time of the 911 Call | 15 participants |
| 7.5% Hypertonic Saline (HS) | Greater Than 10 Units PRBC and Died Within 28 Days From the Time of the 911 Call | 14 participants |
| 0.9% Normal Saline | Greater Than 10 Units PRBC and Died Within 28 Days From the Time of the 911 Call | 32 participants |
Comparison: The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received greater than 10 units of PRBC.p-value: 0.34test for proportions
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Greater Than 10 Units PRBC and Died Within 6 Hours of Admission to the Hospital | 9 participants |
| 7.5% Hypertonic Saline (HS) | Greater Than 10 Units PRBC and Died Within 6 Hours of Admission to the Hospital | 9 participants |
| 0.9% Normal Saline | Greater Than 10 Units PRBC and Died Within 6 Hours of Admission to the Hospital | 22 participants |
Comparison: The null hypothesis is that there are no differences in the percent of patients who died within 6 hours of admission to the hospital between the three groups among the patients who received greater than 10 units of PRBC.p-value: 0.35test for proportions
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Greater Than 10 Units PRBC in First 24 Hours | 36 participants |
| 7.5% Hypertonic Saline (HS) | Greater Than 10 Units PRBC in First 24 Hours | 40 participants |
| 0.9% Normal Saline | Greater Than 10 Units PRBC in First 24 Hours | 61 participants |
Comparison: The null hypothesis is that there are no differences in the percent of patients who received greater than 10 units of PRBC in first 24 hours between the three groups.p-value: 0.97test for proportions
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Packed Red Blood Cells (PRBC) First 24 Hours | 4.81 units of packed red blood cells | Standard Deviation 8.12 |
| 7.5% Hypertonic Saline (HS) | Packed Red Blood Cells (PRBC) First 24 Hours | 4.61 units of packed red blood cells | Standard Deviation 7.46 |
| 0.9% Normal Saline | Packed Red Blood Cells (PRBC) First 24 Hours | 5.15 units of packed red blood cells | Standard Deviation 8.29 |
Comparison: The null hypothesis is that there are no differences in the average number of PRBC units given within the first 24 hours between the three groups.p-value: 0.69ANOVA
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Presence of Nosocomial Infection Through Day 28 | 52 participants |
| 7.5% Hypertonic Saline (HS) | Presence of Nosocomial Infection Through Day 28 | 63 participants |
| 0.9% Normal Saline | Presence of Nosocomial Infection Through Day 28 | 89 participants |
Comparison: The null hypothesis is that there are no differences in the percent of patients with the Presence of Nosocomial Infection through day 28 between the three groups.p-value: 0.8test for proportions
Secondary
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
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Survival at Hospital Discharge | 163 participants | 26.3 |
| 7.5% Hypertonic Saline (HS) | Survival at Hospital Discharge | 185 participants | 28.3 |
| 0.9% Normal Saline | Survival at Hospital Discharge | 278 participants | 27.5 |
Comparison: The null hypothesis is that there are no differences in the percent of patients who survived to hospital discharge between the three groups.p-value: 0.85test for proportions
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Total Fluids First 24 Hours | 11.4 Liters | Standard Deviation 9.6 |
| 7.5% Hypertonic Saline (HS) | Total Fluids First 24 Hours | 11.6 Liters | Standard Deviation 10.4 |
| 0.9% Normal Saline | Total Fluids First 24 Hours | 12.3 Liters | Standard Deviation 12.1 |
Comparison: The null hypothesis is that there are no differences in the average amount of Total fluids given within the first 24 hours between the three groups.p-value: 0.57ANOVA
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Ventilator-free Days Through Day 28 | 18 days | Standard Deviation 12.3 |
| 7.5% Hypertonic Saline (HS) | Ventilator-free Days Through Day 28 | 17 days | Standard Deviation 12.2 |
| 0.9% Normal Saline | Ventilator-free Days Through Day 28 | 17.5 days | Standard Deviation 12.4 |
Comparison: The null hypothesis is that there are no differences in the average number of Ventilator-free days through day 28 between the three groups.p-value: 0.66ANOVA
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Worst Multiple Organ Dysfunction Score (MODS) Mean Through Day 28 | 8.7 Scores on a scale | Standard Deviation 9.8 |
| 7.5% Hypertonic Saline (HS) | Worst Multiple Organ Dysfunction Score (MODS) Mean Through Day 28 | 9.3 Scores on a scale | Standard Deviation 9.6 |
| 0.9% Normal Saline | Worst Multiple Organ Dysfunction Score (MODS) Mean Through Day 28 | 8.8 Scores on a scale | Standard Deviation 9.7 |
Comparison: The null hypothesis is that there are no differences in average Worst Multiple Organ Dysfunction Scores (MODS) through day 28 between the three groups.p-value: 0.73ANOVA
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Zero Units PRBC and Died in Field or Emergency Department (ED) | 14 participants |
| 7.5% Hypertonic Saline (HS) | Zero Units PRBC and Died in Field or Emergency Department (ED) | 23 participants |
| 0.9% Normal Saline | Zero Units PRBC and Died in Field or Emergency Department (ED) | 13 participants |
Comparison: The null hypothesis is that there are no differences in the percent of patients who died in field or ED between the three groups among the patients who received zero units of PRBC.p-value: <0.01test for proportions
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Zero Units PRBC and Died Within 28 Days From the Time of the 911 Call | 22 participants |
| 7.5% Hypertonic Saline (HS) | Zero Units PRBC and Died Within 28 Days From the Time of the 911 Call | 31 participants |
| 0.9% Normal Saline | Zero Units PRBC and Died Within 28 Days From the Time of the 911 Call | 18 participants |
Comparison: The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received zero units of PRBC.p-value: <0.01test for proportions
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Zero Units PRBC and Died Within 6 Hours of Admission to the Hospital | 15 participants |
| 7.5% Hypertonic Saline (HS) | Zero Units PRBC and Died Within 6 Hours of Admission to the Hospital | 23 participants |
| 0.9% Normal Saline | Zero Units PRBC and Died Within 6 Hours of Admission to the Hospital | 14 participants |
Comparison: The null hypothesis is that there are no differences in percent of patients who died within 6 hours of admission to the hospital between the three groups among patients who received zero units of PRBC.p-value: <0.02test for proportions
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7.5% Hypertonic Saline/6% Dextran-70 (HSD) | Zero Units PRBC in First 24 Hours | 91 participants |
| 7.5% Hypertonic Saline (HS) | Zero Units PRBC in First 24 Hours | 104 participants |
| 0.9% Normal Saline | Zero Units PRBC in First 24 Hours | 139 participants |
Comparison: The null hypothesis is that there are no differences in the percent of patients who received zero units of PRBC in the first 24 hours between the three groups.p-value: 0.48test for proportions