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Hypertonic Resuscitation Following Traumatic Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00316017
Recruitment Status : Terminated (Futility & potential safety concern (increased early mortality in the HS/HSD arms for those with no PRBC in 1st 24 hr, post-randomization subgp))
First Posted : April 19, 2006
Results First Posted : November 11, 2010
Last Update Posted : March 1, 2011
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
The Institute of Circulatory and Respiratory Health (ICRH)
Defence Research and Development Canada
Information provided by:
University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Shock, Traumatic
Interventions Drug: 7.5% hypertonic saline/6% Dextran-70 (HSD)
Drug: 7.5% hypertonic saline (HS)
Drug: 0.9% normal saline
Enrollment 895
Recruitment Details 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 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.
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml 7.5% hypertonic saline (HS) 250ml dose 0.9% normal saline 250 ml dose as placebo
Period Title: Overall Study
Started 231 [1] 269 [2] 395 [3]
Completed 220 256 376
Not Completed 11 13 19
Reason Not Completed
Protocol Violation             11             13             19
[1]
11 of 11 not completed due to "Bag Opened Not Given" (BONG)
[2]
12 of 13 not completed due to BONG; 1 not completed was a prisoner who was excluded
[3]
19 of 19 not complete due to BONG
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline Total
Hide Arm/Group Description 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml 7.5% hypertonic saline (HS) 250ml dose 0.9% normal saline 250 ml dose as placebo Total of all reporting groups
Overall Number of Baseline Participants 220 256 376 852
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 220 participants 256 participants 376 participants 852 participants
<=18 years 13 13 23 49
Between 18 and 65 years 188 225 332 745
>=65 years 18 18 21 57
[1]
Measure Description: The HSD group included one subject with no age data available.
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 220 participants 256 participants 376 participants 852 participants
37.7  (17.3) 36.8  (16.1) 36.2  (16.4) 36.7  (16.5)
[1]
Measure Description: The HSD group included one subject with no age data available.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 220 participants 256 participants 376 participants 852 participants
Female
50
  22.7%
51
  19.9%
85
  22.6%
186
  21.8%
Male
170
  77.3%
205
  80.1%
291
  77.4%
666
  78.2%
[1]
Measure Description: Description only includes those subjects who received the study fluid.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 220 participants 256 participants 376 participants 852 participants
United States 177 212 283 672
Canada 43 44 93 180
1.Primary Outcome
Title 28 Day Survival
Hide Description 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).
Time Frame 28 days from time of Emergency Department (ED) arrival
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, analysis was done on only those subjects who received the study fluid per randomization; this was defined as that the study fluid had been connected to the patient's IV.
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 220 256 376
Measure Type: Number
Unit of Measure: participants
164 187 279
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the percent of patients who survived to day 28 day between the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method test for proportions
Comments [Not Specified]
2.Secondary Outcome
Title Adult Respiratory Distress Syndrome(ARDS)-Free Survival Through Day 28
Hide Description Absence of diagnosis of Adult Respiratory Distress Syndrome and alive through day 28
Time Frame 28 days from time of ED arrival
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 220 256 376
Measure Type: Number
Unit of Measure: participants
147 170 246
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in ARDS-free survival through day 28 between the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method test for proportions
Comments [Not Specified]
3.Secondary Outcome
Title Worst Multiple Organ Dysfunction Score (MODS) Mean Through Day 28
Hide Description

Multiple Organ Dysfunction Score is described as:

Six organ systems were chosen, and a score of 0-4 allotted for each organ according to function (0 being normal function through to 4 for most severe dysfunction) with a maximum score of 24. The worst score based on available data (missing values were assumed normal) in each 24-hour period is taken for calculation of the aggregate score.

Time Frame 28 days from time of ED arrival
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 220 256 376
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
8.7  (9.8) 9.3  (9.6) 8.8  (9.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in average Worst Multiple Organ Dysfunction Scores (MODS) through day 28 between the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Presence of Nosocomial Infection Through Day 28
Hide Description Includes one or more nosocomial infections from the following list: pneumonia, blood stream infection, urinary tract infection and wound infection
Time Frame Within 28 days of injury, while hospitalized
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 220 256 376
Measure Type: Number
Unit of Measure: participants
52 63 89
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the percent of patients with the Presence of Nosocomial Infection through day 28 between the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method test for proportions
Comments [Not Specified]
5.Secondary Outcome
Title Packed Red Blood Cells (PRBC) First 24 Hours
Hide Description The numbers of units of packed red blood cells transfused in the first 24 hours
Time Frame First 24 hours from the time of 911 call
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 220 256 376
Mean (Standard Deviation)
Unit of Measure: units of packed red blood cells
4.81  (8.12) 4.61  (7.46) 5.15  (8.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the average number of PRBC units given within the first 24 hours between the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Total Fluids First 24 Hours
Hide Description The total amount of IV fluids given in the pre-hospital setting and the hospital setting in the first 24 hours following the time of 911 call
Time Frame First 24 hours from the time of of 911 call
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 220 256 376
Mean (Standard Deviation)
Unit of Measure: Liters
11.4  (9.6) 11.6  (10.4) 12.3  (12.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the average amount of Total fluids given within the first 24 hours between the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Ventilator-free Days Through Day 28
Hide Description The number of days beginning with the day of 911 call counted as "Day O" through day 28 that the patient did not require mechanical ventilation
Time Frame Duration of hospital stay through day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 220 256 376
Mean (Standard Deviation)
Unit of Measure: days
18  (12.3) 17  (12.2) 17.5  (12.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the average number of Ventilator-free days through day 28 between the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title Days Alive Out of the Intensive Care Unit (ICU) Through Day 28
Hide Description The number of days the patient is alive and not being cared for in the intensive care unit
Time Frame First 28 days from the time of 911 call
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 220 256 376
Mean (Standard Deviation)
Unit of Measure: days
16.4  (12.3) 15.7  (12.0) 16  (12.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the average number of Days alive out of the ICU through day 28 between the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Days Alive Out of the Hospital Through Day 28
Hide Description The number of days the patient is alive and no longer an inpatient in the hospital through day 28
Time Frame First 28 days from the time of 911 call
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 220 256 376
Mean (Standard Deviation)
Unit of Measure: days
10.3  (10.7) 10.3  (10.8) 10.1  (10.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the average number of Days alive out of the hospital through day 28 between the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method ANOVA
Comments [Not Specified]
10.Secondary Outcome
Title Survival at Hospital Discharge
Hide Description Alive at the time of discharge from the Level One or Two trauma hospital. This did not include disposition from rehabilitation facilities.
Time Frame Duration of hospital stay through to discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 220 256 376
Measure Type: Number
Unit of Measure: participants
163 185 278
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the percent of patients who survived to hospital discharge between the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method test for proportions
Comments [Not Specified]
11.Secondary Outcome
Title Zero Units PRBC in First 24 Hours
Hide Description This is the total number of subjects who received no blood products in the first 24 hours from the time of the 911 call.
Time Frame From the time dispatch received the 911 call to the end of the first 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 220 256 376
Measure Type: Number
Unit of Measure: participants
91 104 139
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the percent of patients who received zero units of PRBC in the first 24 hours between the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method test for proportions
Comments [Not Specified]
12.Secondary Outcome
Title Zero Units PRBC and Died in Field or Emergency Department (ED)
Hide Description This is the total number of subjects who died in the field or the ED from the set of subjects who received no blood products.
Time Frame From the time dispatch received 911 call to the time of death in the field or ED
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 91 104 139
Measure Type: Number
Unit of Measure: participants
14 23 13
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the percent of patients who died in field or ED between the three groups among the patients who received zero units of PRBC.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method test for proportions
Comments [Not Specified]
13.Secondary Outcome
Title Zero Units PRBC and Died Within 6 Hours of Admission to the Hospital
Hide Description This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received no blood products.
Time Frame The first 6 hours from the time of admission to the hospital
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 91 104 139
Measure Type: Number
Unit of Measure: participants
15 23 14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in percent of patients who died within 6 hours of admission to the hospital between the three groups among patients who received zero units of PRBC.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.02
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method test for proportions
Comments [Not Specified]
14.Secondary Outcome
Title Zero Units PRBC and Died Within 28 Days From the Time of the 911 Call
Hide Description This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received no units of PRBC.
Time Frame From the time dispatch received the 911 call to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 91 104 139
Measure Type: Number
Unit of Measure: participants
22 31 18
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received zero units of PRBC.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method test for proportions
Comments [Not Specified]
15.Secondary Outcome
Title 1-9 Units PRBC in First 24 Hours
Hide Description This is the total number of subjects who received 1 to 9 units of packed red blood cells (PRBC) in the first 24 hours from the time of the 911 call.
Time Frame From the time dispatch received the 911 call to the end of the first 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 220 256 376
Measure Type: Number
Unit of Measure: participants
92 111 175
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the percent of patients who received 1-9 units PRBC in the first 24 hours between the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method test for proportions
Comments [Not Specified]
16.Secondary Outcome
Title 1-9 Units PRBC and Died in Field or ED
Hide Description This is the total number of subjects who received 1 to 9 units of packed red blood cells (PRBC) among the patients who died in the field or the ED.
Time Frame From the time dispatch received 911 call to the time of death in the field or ED
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 92 111 175
Measure Type: Number
Unit of Measure: participants
11 10 14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the percent of patients who died in Field or ED between the three groups among the patients who received 1-9 units of PRBC.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method test for proportions
Comments [Not Specified]
17.Secondary Outcome
Title 1-9 Units PRBC and Died Within 6 Hours of Admission to the Hospital
Hide Description This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received 1 to 9 units of packed red blood cells (PRBC).
Time Frame The first 6 hours from the time of admission to the hospital
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 92 111 175
Measure Type: Number
Unit of Measure: participants
12 17 25
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the percent of patients who died within 6 hours of admission to the hospital between the three groups among the patients who received 1-9 units of PRBC.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method test for proportions
Comments [Not Specified]
18.Secondary Outcome
Title 1-9 Units PRBC and Died Within 28 Days From the Time of the 911 Call
Hide Description This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received 1 to 9 units of packed red blood cells (PRBC).
Time Frame From the time dispatch received the 911 call to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 92 111 175
Measure Type: Number
Unit of Measure: participants
19 24 46
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received 1-9 units of PRBC.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method test for proportions
Comments [Not Specified]
19.Secondary Outcome
Title Greater Than 10 Units PRBC in First 24 Hours
Hide Description This is the total number of subjects who received greater than 10 units of packed red blood cells (PRBC) in the first 24 hours from the time of the 911 call.
Time Frame From the time dispatch received the 911 call to the end of the first 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 220 256 376
Measure Type: Number
Unit of Measure: participants
36 40 61
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the percent of patients who received greater than 10 units of PRBC in first 24 hours between the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method test for proportions
Comments [Not Specified]
20.Secondary Outcome
Title Greater Than 10 Units PRBC and Died in Field or ED
Hide Description This is the total number of subjects who died in the field or the ED among the patients who received greater than 10 units of packed red blood cells (PRBC).
Time Frame From the time dispatch received 911 call to the time of death in the field or ED
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 36 40 61
Measure Type: Number
Unit of Measure: participants
0 0 3
21.Secondary Outcome
Title Greater Than 10 Units PRBC and Died Within 6 Hours of Admission to the Hospital
Hide Description This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received greater than 10 units of packed red blood cells (PRBC).
Time Frame The first 6 hours from the time of admission to the hospital
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 36 40 61
Measure Type: Number
Unit of Measure: participants
9 9 22
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the percent of patients who died within 6 hours of admission to the hospital between the three groups among the patients who received greater than 10 units of PRBC.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method test for proportions
Comments [Not Specified]
22.Secondary Outcome
Title Greater Than 10 Units PRBC and Died Within 28 Days From the Time of the 911 Call
Hide Description This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received greater than 10 units of packed red blood cells (PRBC).
Time Frame From the time dispatch received the 911 call to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description:
7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
7.5% hypertonic saline (HS) 250ml dose
0.9% normal saline 250 ml dose as placebo
Overall Number of Participants Analyzed 36 40 61
Measure Type: Number
Unit of Measure: participants
15 14 32
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5% Hypertonic Saline/6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline
Comments The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received greater than 10 units of PRBC.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.
Method test for proportions
Comments [Not Specified]
Time Frame Between May 2006 and August 2009, which was 3 years and 3 months
Adverse Event Reporting Description Serial blood sodium levels were drawn to monitor the effects of the hypertonic saline solutions; Serial head CT's were done to monitor for intracranial hemorrhage
 
Arm/Group Title 7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Hide Arm/Group Description 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml 7.5% hypertonic saline (HS) 250ml dose 0.9% normal saline 250 ml dose as placebo
All-Cause Mortality
7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/220 (9.55%)      25/256 (9.77%)      21/376 (5.59%)    
Blood and lymphatic system disorders       
Hypernatremia that required therapeutic intervention  [1]  2/220 (0.91%)  2 5/256 (1.95%)  5 5/376 (1.33%)  5
Hypernatremia that did not required therapeutic intervention  [2]  7/220 (3.18%)  7 6/256 (2.34%)  6 1/376 (0.27%)  1
Nervous system disorders       
Increased intracranial hemorrrhage  [3]  12/220 (5.45%)  12 14/256 (5.47%)  14 15/376 (3.99%)  15
Indicates events were collected by systematic assessment
[1]
Serum sodium>160 mEq/L requiring therapeutic intervention
[2]
Serum sodium>160 mEq/L that did not require therapeutic intervention
[3]
Evidence observed on serial head CT scanning
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
7.5% Hypertonic Saline/6% Dextran-70 (HSD) 7.5% Hypertonic Saline (HS) 0.9% Normal Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/220 (0.45%)      1/256 (0.39%)      1/376 (0.27%)    
Blood and lymphatic system disorders       
Pain, rash, hypotension secondary to a transfusion reaction * [1]  0/220 (0.00%)  0 0/256 (0.00%)  0 1/376 (0.27%)  1
Nervous system disorders       
Seizure activity * [2]  1/220 (0.45%)  1 0/256 (0.00%)  0 0/376 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Complete placental abruption leading to fetal demise * [3]  0/220 (0.00%)  0 1/256 (0.39%)  1 0/376 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
200 cc red blood cells typed for another patient and not felt to be related to study intervention
[2]
Observed in prehospital setting during 7.5% hypertonic saline/6% dextran-70 (HSD) fluid administration
[3]
Protocol violation: enrolled obviously pregnant woman, 6 months gestation
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susanne May, PhD
Organization: Clinical Trial Center, University of Washington, Seattle, WA
Phone: 206-685-1302
EMail: sjmay@uw.edu
Layout table for additonal information
Responsible Party: Gerald van Belle, PhD/Prinicipal Investigator, Resuscitation Outcomes Consortium Data Coordinating Center
ClinicalTrials.gov Identifier: NCT00316017    
Other Study ID Numbers: 28226-A - IND 12506
5U01HL077863-05 ( U.S. NIH Grant/Contract )
IND #12506 (shock cohort) ( Other Identifier: FDA )
First Submitted: April 17, 2006
First Posted: April 19, 2006
Results First Submitted: September 2, 2010
Results First Posted: November 11, 2010
Last Update Posted: March 1, 2011