Hypertonic Resuscitation Following Traumatic Injury

NCT00316017 | Terminated Phase 3 Results DMC

• 3 other identifiers: 28226-A - IND 125065U01HL077863-05IND #12506 (shock cohort)
• Study Type: interventional
• Target: 895
• Locations: 2 countries
• Sites: 10

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.

Conditions

Shock, Traumatic

Keywords

Trauma; Shock

Outcome Measures

Primary Outcomes (1)

• 28 Day Survival

  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).

  28 days from time of Emergency Department (ED) arrival

Secondary Outcomes (21)

• 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

Study Arms (3)

1

EXPERIMENTAL

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

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

2

EXPERIMENTAL

7.5% hypertonic saline (HS)

Drug: 7.5% hypertonic saline (HS)

3

PLACEBO COMPARATOR

0.9% normal saline

Drug: 0.9% normal saline

Interventions

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

250 cc dose given as a one-time intravenous (IV) bolus in the pre-hospital setting.

Also known as: RescueFlo

1

7.5% hypertonic saline (HS) DRUG

250 cc dose given as a one-time IV bolus in the pre-hospital setting.

2

0.9% normal saline DRUG

250 cc dose given as a one-time IV bolus in the pre-hospital setting.

3

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Blunt or penetrating trauma
• Prehospital Systolic Blood Pressure (SBP) \<= 70;OR
• Prehospital SBP 71-90 AND Hear Rate (HR) ≥108
• years of age or older, or 50kg or more if age unknown

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• The Institute of Circulatory and Respiratory Health (ICRH): collaborator
• Defence Research and Development Canada: collaborator

Study Sites (10)

Alabama Resuscitaion Center, University of Alabama

Birmingham, Alabama, 35249, United States

Location

UCSD-San Diego Resuscitation Research Center

San Diego, California, 92103, United States

Location

Iowa Resuscitation Network, University of Iowa Carver College of Medicine

Iowa City, Iowa, 52242, United States

Location

Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University

Portland, Oregon, 97239, United States

Location

The Pittsburgh Resuscitation Network, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Seattle-King County Center For Resuscitation Research, University of Washington

Seattle, Washington, 98195, United States

Location

Milwaukee Resuscitation Network, Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research Institute

Ottawa, Ontario, K1Y4E9, Canada

Location

Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto

Toronto, Ontario, M5B1W8, Canada

Location

Related Publications (2)

• Bulger EM, May S, Kerby JD, Emerson S, Stiell IG, Schreiber MA, Brasel KJ, Tisherman SA, Coimbra R, Rizoli S, Minei JP, Hata JS, Sopko G, Evans DC, Hoyt DB; ROC investigators. Out-of-hospital hypertonic resuscitation after traumatic hypovolemic shock: a randomized, placebo controlled trial. Ann Surg. 2011 Mar;253(3):431-41. doi: 10.1097/SLA.0b013e3181fcdb22.

  PMID: 21178763 RESULT

• Tisherman SA, Schmicker RH, Brasel KJ, Bulger EM, Kerby JD, Minei JP, Powell JL, Reiff DA, Rizoli SB, Schreiber MA. Detailed description of all deaths in both the shock and traumatic brain injury hypertonic saline trials of the Resuscitation Outcomes Consortium. Ann Surg. 2015 Mar;261(3):586-90. doi: 10.1097/SLA.0000000000000837.

  PMID: 25072443 DERIVED

MeSH Terms

Conditions

Shock, Traumatic; Wounds and Injuries; Shock

Interventions

Saline Solution, Hypertonic; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions

Limitations and Caveats

The trial was stopped early for futility in the presence of a potential safety concern regarding increased mortality among patients receiving hypertonic solutions and no blood transfusions. This was no longer evident 6 hr after hospital admission.

Results Point of Contact

• Title: Susanne May, PhD
• Organization: Clinical Trial Center, University of Washington, Seattle, WA

sjmay@uw.edu

206-685-1302

Study Officials

• Myron L Weisfeldt, MD

  Resuscitation Outcomes Consortium

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 17, 2006
• First Posted: April 19, 2006
• Study Start: May 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 1, 2011
• Results First Posted: November 11, 2010

Record last verified: 2011-02

Locations

US (8); CA (2)