Hypertonic Resuscitation Following Traumatic Injury

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00316017
• Date of registration: 17/04/2006
• Primary sponsor: University of Washington
• Public title: Hypertonic Resuscitation Following Traumatic Injury
• Scientific title: Phase 3 Study of Hypertonic Resuscitation Following Traumatic Injury With Hypovolemic Shock
• Date of first enrolment: May 2006
• Target sample size: 895
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00316017
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Canada, United States

Contacts

• Name: Myron L Weisfeldt, MD
• Affiliation: Resuscitation Outcomes Consortium

Key inclusion & exclusion criteria

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



Age minimum: 15 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Shock, Traumatic

Intervention(s)

Drug: 0.9% normal saline

Drug: 7.5% hypertonic saline (HS)

Drug: 7.5% hypertonic saline/6% Dextran-70 (HSD)

Primary Outcome(s)

28 Day Survival [Time Frame: 28 days from time of Emergency Department (ED) arrival]

Secondary Outcome(s)

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]

1-9 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]

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]

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]

Adult Respiratory Distress Syndrome(ARDS)-Free Survival Through Day 28 [Time Frame: 28 days from time of ED arrival]

Days Alive Out of the Hospital Through Day 28 [Time Frame: First 28 days from the time of 911 call]

Days Alive Out of the Intensive Care Unit (ICU) Through Day 28 [Time Frame: First 28 days from the time of 911 call]

Greater Than 10 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]

Greater Than 10 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]

Greater Than 10 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]

Greater Than 10 Units PRBC in First 24 Hours [Time Frame: From the time dispatch received the 911 call to the end of the first 24 hours]

Packed Red Blood Cells (PRBC) First 24 Hours [Time Frame: First 24 hours from the time of 911 call]

Presence of Nosocomial Infection Through Day 28 [Time Frame: Within 28 days of injury, while hospitalized]

Survival at Hospital Discharge [Time Frame: Duration of hospital stay through to discharge]

Total Fluids First 24 Hours [Time Frame: First 24 hours from the time of of 911 call]

Ventilator-free Days Through Day 28 [Time Frame: Duration of hospital stay through day 28]

Worst Multiple Organ Dysfunction Score (MODS) Mean Through Day 28 [Time Frame: 28 days from time of ED arrival]

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]

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]

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]

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]

Secondary ID(s)

28226-A - IND 12506

5U01HL077863-05

IND #12506 (shock cohort)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Defence Research and Development Canada

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Neurological Disorders and Stroke (NINDS)

The Institute of Circulatory and Respiratory Health (ICRH)