Phase 3 Study of Hypertonic Resuscitation Following Traumatic Injury With Hypovolemic Shock
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 895
- 试验地点
- 10
- 主要终点
- 28 Day Survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
3
0.9% normal saline
干预措施: 0.9% normal saline (Drug)
1
7.5% hypertonic saline/6% Dextran-70 (HSD)
干预措施: 7.5% hypertonic saline/6% Dextran-70 (HSD) (Drug)
2
7.5% hypertonic saline (HS)
干预措施: 7.5% hypertonic saline (HS) (Drug)
结局指标
主要结局
28 Day Survival
时间窗: 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).
次要结局
- Adult Respiratory Distress Syndrome(ARDS)-Free Survival Through Day 28(28 days from time of ED arrival)
- Worst Multiple Organ Dysfunction Score (MODS) Mean Through Day 28(28 days from time of ED arrival)
- Presence of Nosocomial Infection Through Day 28(Within 28 days of injury, while hospitalized)
- Packed Red Blood Cells (PRBC) First 24 Hours(First 24 hours from the time of 911 call)
- Total Fluids First 24 Hours(First 24 hours from the time of of 911 call)
- Ventilator-free Days Through Day 28(Duration of hospital stay through day 28)
- Days Alive Out of the Intensive Care Unit (ICU) Through Day 28(First 28 days from the time of 911 call)
- Days Alive Out of the Hospital Through Day 28(First 28 days from the time of 911 call)
- Survival at Hospital Discharge(Duration of hospital stay through to discharge)
- Zero Units PRBC in First 24 Hours(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)(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(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(From the time dispatch received the 911 call to 28 days)
- 1-9 Units PRBC in First 24 Hours(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(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(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(From the time dispatch received the 911 call to 28 days)
- 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)
- 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)
- 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)
- 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)