Hypertonic Resuscitation Following Traumatic Injury

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled by Emergency Medicine Services (EMS) personnel in the pre-hospital setting based on pre-defined inclusion/exclusion criteria. The first subject was enrolled on May 9, 2006 and the last subject was enrolled on August 25, 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
895 subjects were randomized. 852 subjects completed the study. Randomization was performed when the outer study fluid bag wrapper was removed in the presence of a patient. To ensure there was no bias, a secondary intention to treat analysis was also performed which included all randomized patients even if the fluid was not administered.

Reporting Groups

	Description
7.5% Hypertonic Saline/6% Dextran-70 (HSD)	7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% Hypertonic Saline (HS)	7.5% hypertonic saline (HS) 250ml dose
0.9% Normal Saline	0.9% normal saline 250 ml dose as placebo

Participant Flow:   Overall Study

	7.5% Hypertonic Saline/6% Dextran-70 (HSD)	7.5% Hypertonic Saline (HS)	0.9% Normal Saline
STARTED	231 [1]	269 [2]	395 [3]
COMPLETED	220	256	376
NOT COMPLETED	11	13	19
Protocol Violation	11	13	19

Reporting Groups

	Description
7.5% Hypertonic Saline/6% Dextran-70 (HSD)	7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% Hypertonic Saline (HS)	7.5% hypertonic saline (HS) 250ml dose
0.9% Normal Saline	0.9% normal saline 250 ml dose as placebo
Total	Total of all reporting groups

Baseline Measures

	7.5% Hypertonic Saline/6% Dextran-70 (HSD)	7.5% Hypertonic Saline (HS)	0.9% Normal Saline	Total
Number of Participants   [units: participants]	220	256	376	852
Age [1] [units: participants]
<=18 years	13	13	23	49
Between 18 and 65 years	188	225	332	745
>=65 years	18	18	21	57
Age [1] [units: years] Mean ± Standard Deviation	37.7  ± 17.3	36.8  ± 16.1	36.2  ± 16.4	36.7  ± 16.5
Gender [2] [units: participants]
Female	50	51	85	186
Male	170	205	291	666
Region of Enrollment   [units: participants]
United States	177	212	283	672
Canada	43	44	93	180

1.  Primary:

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

2.  Secondary:

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

3.  Secondary:

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

4.  Secondary:

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

5.  Secondary:

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

6.  Secondary:

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

7.  Secondary:

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

8.  Secondary:

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

9.  Secondary:

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

10.  Secondary:

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

11.  Secondary:

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 ]

12.  Secondary:

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 ]

13.  Secondary:

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 ]

14.  Secondary:

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 ]

15.  Secondary:

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 ]

16.  Secondary:

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 ]

17.  Secondary:

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 ]

18.  Secondary:

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 ]

19.  Secondary:

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 ]

20.  Secondary:

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 ]

21.  Secondary:

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 ]

22.  Secondary:

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 ]