Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma (HypoResus)

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Susanne May, University of Washington
ClinicalTrials.gov Identifier:
NCT01411852
First received: August 3, 2011
Last updated: December 30, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention Phase
Blunt Trauma
Penetrating Wound
Hemorrhagic Shock
Drug: 0.9% Sodium Chloride 250 mL bolus
Drug: 0.9% Sodium Chloride 2000 mL bolus
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Field Trial of Hypotensive Resuscitation Versus Standard Resuscitation in Patients With Hemorrhagic Shock After Trauma: A Pilot Trial

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    The 24 hour mortality endpoint for the total number of patients each arm


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    Eligibility criteria:

    Inclusion Criteria

    Included will be those with:

    1. Blunt or penetrating injury
    2. Age ≥15yrs or weight ≥50kg if age is unknown
    3. Prehospital SBP ≤ 90 mmHg 5.3 Exclusion Criteria

    Excluded will be those with:

    1. Ground level falls
    2. Evidence of severe blunt or penetrating head injury with a Glasgow Coma Score (GCS) ≤ 8
    3. Bilateral paralysis secondary to suspected spinal cord injury
    4. Fluid greater than 250 ml was given prior to randomization
    5. Cardiopulmonary resuscitation (CPR) by Emergency Medical Services (EMS) prior to randomization
    6. Known prisoners
    7. Known or suspected pregnancy
    8. Drowning or asphyxia due to hanging
    9. Burns Total Body Surface Area (TBSA) > 20%
    10. 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Increased plasma creatinine > 3 x reference measure (ED admission) or acute plasma creatinine = 350 umol/L or acute rise = 44 umol/L or urine output < 0.3 mL/k/h x 24h. Only measured for patients with at least 2 days of ICU stay assessed.

  • Ventilator Free Days Through Day 28 [ Time Frame: From day of the 911 call through Day 28 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

  • Blunt Trauma 24 Hour Mortality [ Time Frame: From time of hospital arrival through first 24 hours ] [ Designated as safety issue: Yes ]
    The 24 hour mortality endpoint for the total number of patients injured by blunt mechanisms in each arm.

  • Penetrating Trauma 24 Hour Mortality [ Time Frame: From time of hospital arrival through first 24 hours ] [ Designated as safety issue: Yes ]
    The 24 hour mortality endpoint for the total number of patients injured by penetrating mechanisms in each arm.

  • In-hospital Mortality [ Time Frame: From day of the 911 call through hospital discharge ] [ Designated as safety issue: Yes ]
    Number of patients who died prior to discharge.


Enrollment: 192
Study Start Date: March 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.9% Sodium Chloride 250 mL bolus
0.9% Sodium Chloride 250 mL bolus - A large bore IV will be placed and a 250cc bag of normal saline (NS) will be hung. If IV placement is difficult, NS can be given through an intraosseous line. Using small bags versus large bags will physically limit the amount of fluid given to patients in the experimental group. The requirement to change the smaller bags of fluid and recheck the pulse or blood pressure will limit the amount of fluid given. The procedure will continue until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first. Hemorrhage control will be defined as ligation of a bleeding vessel, packing of a solid organ, removal of a solid organ, and angiographic embolization of a bleeding vessel.
Drug: 0.9% Sodium Chloride 250 mL bolus
Emergency Medicine Systems (EMS) agencies and in-hospital providers will be given the option to utilize either systolic blood pressure (SBP) or radial pulse as the endpoint for fluid resuscitation to patients randomized to the experimental group. Patients will receive a 250 ml bolus of normal saline (NS) only if the SBP is less than 70 mmHg or the radial pulse is not palpable. If the SBP is greater than or equal to 70 mmHg or the radial pulse is palpable, NS will be given to keep the vein open. The presence or absence of a radial pulse or the SBP will be documented before and after each bolus. The study will continue repeating the randomization procedure using only 250 ml bags of NS until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first.
Other Names:
  • isotonic saline
  • normal saline
Active Comparator: 0.9% Sodium Chloride 2000 mL bolus
0.9% Sodium Chloride 2000 mL bolus - The treatment of the control group will be consistent with traditional Prehospital Trauma Life Support and Advanced Trauma Life Support guidelines which recommend early aggressive fluid resuscitation. An intravenous line (IV) will be placed and a 1000cc bag of normal saline will be hung. If IV placement is difficult, fluid can be given through an intraosseous line. This procedure will continue until either 2 hours after hospital arrival or until control of hemorrhage is achieved whichever occurs first. Hemorrhage control will be defined as ligation of a bleeding vessel, packing of a solid organ, removal of a solid organ, and angiographic embolization of a bleeding vessel.
Drug: 0.9% Sodium Chloride 2000 mL bolus
Emergency Medicine Systems (EMS) personnel and in-hospital providers will utilize the systolic blood pressure SBP as the endpoint for delivering fluid resuscitation to patients randomized to the control group. If the SBP is equal to or less than 90 mmHg, the EMS personnel will start infusing a 1000 ml bolus of normal saline (NS) and will continue using only 1000 ml bags of NS as needed. If the total fluid resuscitation exceeds 2 liters, fluid will be stopped when the SBP exceeds 110 mmHg and restarted as necessary to maintain a goal SBP of 110 mmHg. The fluid will be given as rapidly as possible. This fluid resuscitation protocol will continue until either 2 hours after hospital arrival or until control of hemorrhage is achieved whichever occurs first.
Other Names:
  • isotonic saline
  • normal saline

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Exclusion Criteria: Excluded will be those with:

  • Ground level falls
  • Evidence of severe blunt or penetrating head injury with a Glasgow Coma Scale (GCS) ≤ 8
  • Bilateral paralysis secondary to suspected spinal cord injury
  • Fluid greater than 250ml was given prior to randomization
  • Cardiopulmonary resuscitation (CPR) by Emergency Medicine Service (EMS) prior to randomization
  • Known prisoners
  • Known or suspected pregnancy
  • Drowning or asphyxia due to hanging
  • Burns over a Total Body Surface Area (TBSA) > 20%
  • Time of call received at dispatch to study intervention > 4 hours
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411852

Locations
United States, Alabama
Alabama Resuscitation Center, University of Alabama
Birmingham, Alabama, United States, 35294
United States, Oregon
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
The Pittsburgh Resuscitation Network, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
United States, Texas
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Wisconsin
Milwaukee Resuscitation Network, Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, British Columbia
Resuscitation Outcomes Consortium Regional Coordinating Center,University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of Washington
Canadian Institutes of Health Research (CIHR)
Investigators
Study Chair: Myron L Weisfeldt, MD Resuscitation Outcomes Consortium
Study Director: David Hoyt, MD Resuscitation Outcomes Consortium
  More Information

Additional Information:
No publications provided

Responsible Party: Susanne May, PhD/Principal Investigator, Resuscitation Outcomes Consortium Data Coordinating Center, University of Washington
ClinicalTrials.gov Identifier: NCT01411852     History of Changes
Other Study ID Numbers: 41071-B, 5U01HL077863-07
Study First Received: August 3, 2011
Results First Received: October 3, 2014
Last Updated: December 30, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Washington:
fluid volume resuscitation
trauma
hemorrhagic shock

Additional relevant MeSH terms:
Shock
Shock, Hemorrhagic
Wounds and Injuries
Wounds, Penetrating
Hemorrhage
Pathologic Processes
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 26, 2015