Clinical Trial: Hypertonic Resuscitation Following Traumatic Injury
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase 3 Study of Hypertonic Resuscitation Following Traumatic Injury With Hypovolemic 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 Summary:
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.
Sponsor: University of WashingtonCurrent Primary Outcome: 28 Day Survival [ Time Frame: 28 days from time of Emergency Department (ED) arrival ]
Original Primary Outcome: 28 Day Survival
Current Secondary Outcome:
- Adult Respiratory Distress Syndrome(ARDS)-Free Survival Through Day 28 [ Time Frame: 28 days from time of ED arrival ]Absence of diagnosis of Adult Respiratory Distress Syndrome and alive through day 28
- Worst Multiple Organ Dysfunction Score (MODS) Mean Through Day 28 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.
- Zero Units PRBC and Died Within 6 Hours of Admission to the Hospital [ Time Frame: 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.
- Zero Units PRBC and Died Within 28 Days From the Time of the 911 Call [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 t
Original Secondary Outcome:
- ARDS criteria met during the first 28 days post injury
- Multiple Organ Dysfunction Score (MODS)
- Presence of nosocomial infection
- Total fluid requirements in the first 24 hours after injury
- Number of days on ventilator
- Duration of hospital stay
Information By: University of Washington
Dates:
Date Received: April 17, 2006
Date Started: May 2006
Date Completion:
Last Updated: February 25, 2011
Last Verified: February 2011
