Clinical Trial: Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Field Trial of Hypotensive Resuscitation Versus Standard Resuscitation in Patients With Hemorrhagic Shock After Trauma: A Pilot Trial
Brief 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.
Detailed Summary:
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Overview This multi-center pilot trial is designed to determine the feasibility and safety of hypotensive resuscitation for the early resuscitation of patients with traumatic shock compared to standard fluid resuscitation. Blunt and penetrating trauma patients with a prehospital systolic blood pressure (SBP) ≤ 90 mmHg will be eligible. In the hypotensive resuscitation group, an intravenous line (IV) will be placed and a radial pulse will be palpated. If the radial pulse is present or the SBP is greater than or equal to 70, a 250 ml bag of normal saline will be hung and maintained at a keep the vein open rate only. If the radial pulse is absent, the 250 ml of normal saline will be given as a bolus. This process using small bags of fluid will be repeated until a radial pulse is palpable or until 2 hours after Emergency Department (ED) arrival or until hemorrhage control has been achieved. The decision to utilize a SBP versus a radial pulse will be made a priori. Patients in the standard fluid resuscitation group will have an IV placed and a 1000 ml bag of normal saline (NS) will be hung. Fluid will be given as rapidly as possible and continued until hospital arrival. If the prehospital or hospital fluid resuscitation exceeds 2 liters, it will be stopped when the SBP exceeds 110 mmHg and restarted as necessary to maintain a goal SBP of 110 mmHg. This randomization scheme will be continued for 2 hours after hospital arrival or until hemorrhage control is achieved whichever occurs first. The randomization will not affect the indications for the administration of blood products but we hypothesize that less blood products and total fluid will be given in the experimental group due to avoidance of the pop-the-clot phenomenon, less hemodilution and less coagulopathy.
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Sponsor: University of Washington
Current Primary Outcome:
- Total Volume of All Crystalloid Given for Early Resuscitation (Feasibility) [ Time Frame: From time of first intravenous or intraosseous insertion through the first 2 hours after hospital arrival or hemorrhage control, which ever occurs first ]The primary feasibility endpoint was early crystalloid volume (ECV) defined as crystalloid infused from Emergency Medical Services (EMS) arrival at the scene until the end of the study period
- 24 Hour Mortality [ Time Frame: From time of hospital arrival through the first 24 hours ]The 24 hour mortality endpoint for the total number of patients each arm
Original Primary Outcome:
- Volume of saline given for resuscitation (feasibility) [ Time Frame: From time of first intravenous or intraosseous access through the first 2 hours after arrival in the final Emergency Department or hemorrhage control, which ever occurs first ]The total volume of normal saline administered to the patients during the intervention time frame
- 24-hour survival (safety) [ Time Frame: From 911 call received at dispatch through the first 24 hours ]24-hour survival of the patients
Current Secondary Outcome:
- Number of Ineligible Patients Enrolled at the Time of Randomization [ Time Frame: From the time the paramedic with study drug kit arrived at patient's side to the time kit was opened prior to ED arrival ]
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 5.3 Exclusion Criteria
Excluded will be those with:
- Ground level falls
- Evidence of severe blunt or penetrating head injury with a Glasgow Coma Score (GCS) ≤ 8
- Bilateral paralysis secondary to suspected spinal cord injury
- Fluid greater than 250 ml was given prior to randomization
- Cardiopulmonary resuscitation (CPR) by Emergency Medical Services (EMS) prior to randomization
- Known prisoners
- Known or suspected pregnancy
- Drowning or asphyxia due to hanging
- Burns Total Body Surface Area (TBSA) > 20%
- Time of call received at dispatch to study intervention > 4 hours
- Total Fluid Requirement During First 24 Hours [ Time Frame: From ED arrival through the first 24 hours ]Total volume of fluid administered during the first 24 hours inclusive of crystalloids, blood products, 3% saline, mannitol, and other colloids
- Total Blood Product Requirements in First 24 Hours [ Time Frame: From ED arrival through the first 24 hours ]Total amount of blood products required: packed red blood cells (PRBC), fresh frozen plasma (FFP), platelets (plts), cryoprecipitate (cryo)
- Base Deficit on Admission to the Emergency Department (ED) [ Time Frame: From final Emergency Department arrival time through first 24 hours ]The first base deficit value reported from arterial blood lab work drawn after arrival in the final Emergency Department. This measure reflects the acid-base balance in the arterial blood. A negative number indicates that the blood is more acid that normal.
- Hemoglobin on Admission to the Emergency Department [ Time Frame: From final Emergency Department arrival time through first 24 hours ]The first hemoglobin value reported from blood drawn in the final Emergency Department
- Platelet Value on Admission [ Time Frame: From final Emergency Department arrival time through first 24 hours ]First platelet value from blood drawn in the the first 24 hours after arrival
- International Normalized Ratio (INR) on Admission to the Emergency Department [ Time Frame: From final Emergency Department arrival time through first 24 hours ]The first International normalized ratio (INR) value reported from blood drawn within the first 24 hours from arrival
- Hemorrhage Control Procedure Within 2 Hours of ED Arrival [ Time Frame: From ED arrival through the first 2 hours ]Hemorrhage control procedures include blood vessel ligated or embolized, organ packed or removed, laparotomy or thoracotomy
- Acute Renal Failure Classification Score of "Risk" Without Glomerular Filtration Rate (GFR) [ Time Frame: From ED arrival through Day 28 ]Increased plasma creatinine > 1.5 x reference measure (ED admission). Urine criteria is based on 6-hour periods for this level of the RIFLE and cannot be assessed since study data are collected for 24-hour periods. This row includes patients who met the "Injury" and "Failure" criteria as well. Only measured for patients with at least 2 days of ICU stay assessed.
- Acute Renal Failure Classification Score of "Injury" Without Glomerular Filtration Rate (GFR) [ Time Frame: From ED arrival through Day 28 ]Increased plasma creatinine > 2 x reference measure (ED admission) or urine output < 0.5 mL/kg/h x 24h. The RIFLE urine criterion for this level actually specifies a 12 hour period of assessment but study data are collected for 24-hr periods. This row includes patients who met the "Failure" criteria as well. Only measured for patients with at least 2 days of ICU stay assessed.
- Acute Renal Failure Classification Score of "Failure" Without Glomerular Filtration Rate (GFR) [ Time Frame: From ED arrival through the first 24 hours ]Incr
Original Secondary Outcome:
- Protocol Violations [ Time Frame: From the time of randomization through the first 24 hours following the time the 911 call was received at dispatch ]Protocol violations will be assessed in the following measurements: 1. amount of non-missing vital signs (either systolic blood pressure or palpable radial pulse) prior and after administration of each bolus of fluid; 2. consistency between vital signs measure and (non-) continuation of fluid as mandated by the treatment arm; 3. percent of exclusions due to potential head injury
- Total fluid requirement during intervention period [ Time Frame: From time of first intravenous or intraosseous access through the first 2 hours after arrival in the final Emergency Department or hemorrhage control, whichever occurs first ]Total volume of fluid administered during the intervention time frame inclusive of crystalloids, blood products, 3% saline, mannitol, and other colloids
- Total Fluid Requirement During First 24 Hours [ Time Frame: From 911 call received at dispatch through the first 24 hours ]Total volume of fluid administered during the first 24 hours inclusive of crystalloids, blood products, 3% saline, mannitol, and other colloids
- Total Blood Product Requirements in First 24 Hours [ Time Frame: From 911 call received at dispatch through the first 24 hours ]Total amount of blood products required: packed red blood cells (PRBC), fresh frozen plasma (FFP), platelets (plts), cryoprecipitate (cryo)
- Base Deficit on Admission to the Emergency Department (ED) [ Time Frame: From final Emergency Department arrival time through the following 24 hours ]The first base deficit value reported from arterial blood lab work drawn after arrival in the final Emergency Department. This measure reflects the acid-base balance in the arterial blood. A negative number indicates that the blood is more acid that normal.
- Hematocrit and hemaglobin on admission to the Emergency Department [ Time Frame: From final Emergency Department arrival time through the following 24 hours ]The first hematocrit and hemaglobin values reported from blood drawn in the final Emergency Department
- Coagulation Parameters on Admission to the Emergency Department [ Time Frame: From final Emergency Department arrival time through the following 24 hours ]The first platelet, protime, prothrombin time, International normalised ratio (INR), and fibrinogen values reported from blood drawn in the final Emergency Department
- Ventilator Free Days Through Day 28 [ Time Frame: From day of the 911 call through Day 28 ]The number of days beginning with the day of the 911 call counted as "Day 0" through Day 28 during which the patient did not require mechanical ventilation. Deaths are assigned the worst score (0).
- Days Alive Out of the Intensive Care Unit (ICU) Through Day 28 [ Time Frame: From day of the 911 call through Day 28 ]The number of days beginning with the day of the 911 call counted as "Day 0" through Day 28 during which 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: From day of the 911 call through Day 28 ]The number of days beginning with the day of the 911 call counted as "Day 0" through Day 28 during which the patient is alive and not being cared for in the hospital
- Worst Acute Renal Failure Classification Score Without Glomerular Filtration Rate (GFR) [ Time Frame: From day of the 911 call through Day 28 ]Beginning with the day of the 911 call counted as "Day 0" through Day 28, the worst acute renal failure classification score recorded using the Risk, Injury, Failure, Loss, and End-stage kidney disease (RIFLE) criteria excluding glomerular filtration rate (GFR) calculated using plasma creatinine and urine output based on weight in kilograms. Classifications: 1. Risk; 2. Injury: and 3. Failure
Information By: University of Washington
Dates:
Date Received: August 3, 2011
Date Started: March 2012
Date Completion:
Last Updated: December 30, 2014
Last Verified: December 2014
- Protocol Violations [ Time Frame: From the time of randomization through the first 24 hours following the time the 911 call was received at dispatch ]
- Total Volume of All Crystalloid Given for Early Resuscitation (Feasibility) [ Time Frame: From time of first intravenous or intraosseous insertion through the first 2 hours after hospital arrival or hemorrhage control, which ever occurs first ]
