Trial Outcomes & Findings for Hypertonic Resuscitation Following Traumatic Injury (NCT NCT00316017)

NCT ID: NCT00316017

Last Updated: 2011-03-01

Results Overview

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).

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 895 participants
• Primary outcome timeframe: 28 days from time of Emergency Department (ED) arrival
• Results posted on: 2011-03-01

Participant Flow

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.

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.

Participant milestones

Measure	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
Overall Study STARTED	231	269	395
Overall Study COMPLETED	220	256	376
Overall Study NOT COMPLETED	11	13	19

Reasons for withdrawal

Measure	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
Overall Study Protocol Violation	11	13	19

Baseline Characteristics

Hypertonic Resuscitation Following Traumatic Injury

Baseline characteristics by cohort

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=220 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=256 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=376 Participants 0.9% normal saline 250 ml dose as placebo	Total n=852 Participants Total of all reporting groups
Age Categorical <=18 years	13 participants n=5 Participants	13 participants n=7 Participants	23 participants n=5 Participants	49 participants n=4 Participants
Age Categorical Between 18 and 65 years	188 participants n=5 Participants	225 participants n=7 Participants	332 participants n=5 Participants	745 participants n=4 Participants
Age Categorical >=65 years	18 participants n=5 Participants	18 participants n=7 Participants	21 participants n=5 Participants	57 participants n=4 Participants
Age Continuous	37.7 years STANDARD_DEVIATION 17.3 • n=5 Participants	36.8 years STANDARD_DEVIATION 16.1 • n=7 Participants	36.2 years STANDARD_DEVIATION 16.4 • n=5 Participants	36.7 years STANDARD_DEVIATION 16.5 • n=4 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	51 Participants n=7 Participants	85 Participants n=5 Participants	186 Participants n=4 Participants
Sex: Female, Male Male	170 Participants n=5 Participants	205 Participants n=7 Participants	291 Participants n=5 Participants	666 Participants n=4 Participants
Region of Enrollment United States	177 participants n=5 Participants	212 participants n=7 Participants	283 participants n=5 Participants	672 participants n=4 Participants
Region of Enrollment Canada	43 participants n=5 Participants	44 participants n=7 Participants	93 participants n=5 Participants	180 participants n=4 Participants

PRIMARY outcome

Timeframe: 28 days from time of Emergency Department (ED) arrival

Population: 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.

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).

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=220 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=256 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=376 Participants 0.9% normal saline 250 ml dose as placebo
28 Day Survival	164 participants	187 participants	279 participants

SECONDARY outcome

Timeframe: 28 days from time of ED arrival

Absence of diagnosis of Adult Respiratory Distress Syndrome and alive through day 28

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=220 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=256 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=376 Participants 0.9% normal saline 250 ml dose as placebo
Adult Respiratory Distress Syndrome(ARDS)-Free Survival Through Day 28	147 participants	170 participants	246 participants

SECONDARY outcome

Timeframe: 28 days from time of ED arrival

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.

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=220 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=256 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=376 Participants 0.9% normal saline 250 ml dose as placebo
Worst Multiple Organ Dysfunction Score (MODS) Mean Through Day 28	8.7 Scores on a scale Standard Deviation 9.8	9.3 Scores on a scale Standard Deviation 9.6	8.8 Scores on a scale Standard Deviation 9.7

SECONDARY outcome

Timeframe: Within 28 days of injury, while hospitalized

Includes one or more nosocomial infections from the following list: pneumonia, blood stream infection, urinary tract infection and wound infection

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=220 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=256 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=376 Participants 0.9% normal saline 250 ml dose as placebo
Presence of Nosocomial Infection Through Day 28	52 participants	63 participants	89 participants

SECONDARY outcome

Timeframe: First 24 hours from the time of 911 call

The numbers of units of packed red blood cells transfused in the first 24 hours

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=220 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=256 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=376 Participants 0.9% normal saline 250 ml dose as placebo
Packed Red Blood Cells (PRBC) First 24 Hours	4.81 units of packed red blood cells Standard Deviation 8.12	4.61 units of packed red blood cells Standard Deviation 7.46	5.15 units of packed red blood cells Standard Deviation 8.29

SECONDARY outcome

Timeframe: First 24 hours from the time of of 911 call

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

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=220 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=256 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=376 Participants 0.9% normal saline 250 ml dose as placebo
Total Fluids First 24 Hours	11.4 Liters Standard Deviation 9.6	11.6 Liters Standard Deviation 10.4	12.3 Liters Standard Deviation 12.1

SECONDARY outcome

Timeframe: Duration of hospital stay through day 28

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

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=220 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=256 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=376 Participants 0.9% normal saline 250 ml dose as placebo
Ventilator-free Days Through Day 28	18 days Standard Deviation 12.3	17 days Standard Deviation 12.2	17.5 days Standard Deviation 12.4

SECONDARY outcome

Timeframe: First 28 days from the time of 911 call

The number of days the patient is alive and not being cared for in the intensive care unit

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=220 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=256 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=376 Participants 0.9% normal saline 250 ml dose as placebo
Days Alive Out of the Intensive Care Unit (ICU) Through Day 28	16.4 days Standard Deviation 12.3	15.7 days Standard Deviation 12.0	16 days Standard Deviation 12.2

SECONDARY outcome

Timeframe: First 28 days from the time of 911 call

The number of days the patient is alive and no longer an inpatient in the hospital through day 28

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=220 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=256 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=376 Participants 0.9% normal saline 250 ml dose as placebo
Days Alive Out of the Hospital Through Day 28	10.3 days Standard Deviation 10.7	10.3 days Standard Deviation 10.8	10.1 days Standard Deviation 10.6

SECONDARY outcome

Timeframe: Duration of hospital stay through to discharge

Alive at the time of discharge from the Level One or Two trauma hospital. This did not include disposition from rehabilitation facilities.

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=220 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=256 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=376 Participants 0.9% normal saline 250 ml dose as placebo
Survival at Hospital Discharge	163 participants 26.3	185 participants 28.3	278 participants 27.5

SECONDARY outcome

Timeframe: From the time dispatch received the 911 call to the end of the first 24 hours

This is the total number of subjects who received no blood products in the first 24 hours from the time of the 911 call.

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=220 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=256 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=376 Participants 0.9% normal saline 250 ml dose as placebo
Zero Units PRBC in First 24 Hours	91 participants	104 participants	139 participants

SECONDARY outcome

Timeframe: From the time dispatch received 911 call to the time of death in the field or ED

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.

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=91 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=104 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=139 Participants 0.9% normal saline 250 ml dose as placebo
Zero Units PRBC and Died in Field or Emergency Department (ED)	14 participants	23 participants	13 participants

SECONDARY outcome

Timeframe: The first 6 hours from the time of admission to the hospital

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.

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=91 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=104 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=139 Participants 0.9% normal saline 250 ml dose as placebo
Zero Units PRBC and Died Within 6 Hours of Admission to the Hospital	15 participants	23 participants	14 participants

SECONDARY outcome

Timeframe: From the time dispatch received the 911 call to 28 days

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.

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=91 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=104 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=139 Participants 0.9% normal saline 250 ml dose as placebo
Zero Units PRBC and Died Within 28 Days From the Time of the 911 Call	22 participants	31 participants	18 participants

SECONDARY outcome

Timeframe: From the time dispatch received the 911 call to the end of the first 24 hours

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.

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=220 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=256 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=376 Participants 0.9% normal saline 250 ml dose as placebo
1-9 Units PRBC in First 24 Hours	92 participants	111 participants	175 participants

SECONDARY outcome

Timeframe: From the time dispatch received 911 call to the time of death in the field or ED

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.

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=92 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=111 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=175 Participants 0.9% normal saline 250 ml dose as placebo
1-9 Units PRBC and Died in Field or ED	11 participants	10 participants	14 participants

SECONDARY outcome

Timeframe: The first 6 hours from the time of admission to the hospital

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).

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=92 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=111 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=175 Participants 0.9% normal saline 250 ml dose as placebo
1-9 Units PRBC and Died Within 6 Hours of Admission to the Hospital	12 participants	17 participants	25 participants

SECONDARY outcome

Timeframe: From the time dispatch received the 911 call to 28 days

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).

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=92 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=111 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=175 Participants 0.9% normal saline 250 ml dose as placebo
1-9 Units PRBC and Died Within 28 Days From the Time of the 911 Call	19 participants	24 participants	46 participants

SECONDARY outcome

Timeframe: From the time dispatch received the 911 call to the end of the first 24 hours

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.

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=220 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=256 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=376 Participants 0.9% normal saline 250 ml dose as placebo
Greater Than 10 Units PRBC in First 24 Hours	36 participants	40 participants	61 participants

SECONDARY outcome

Timeframe: From the time dispatch received 911 call to the time of death in the field or ED

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).

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=36 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=40 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=61 Participants 0.9% normal saline 250 ml dose as placebo
Greater Than 10 Units PRBC and Died in Field or ED	0 participants	0 participants	3 participants

SECONDARY outcome

Timeframe: The first 6 hours from the time of admission to the hospital

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).

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=36 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=40 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=61 Participants 0.9% normal saline 250 ml dose as placebo
Greater Than 10 Units PRBC and Died Within 6 Hours of Admission to the Hospital	9 participants	9 participants	22 participants

SECONDARY outcome

Timeframe: From the time dispatch received the 911 call to 28 days

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).

Outcome measures

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=36 Participants 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=40 Participants 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=61 Participants 0.9% normal saline 250 ml dose as placebo
Greater Than 10 Units PRBC and Died Within 28 Days From the Time of the 911 Call	15 participants	14 participants	32 participants

Adverse Events

7.5% Hypertonic Saline/6% Dextran-70 (HSD)

Serious events: 21 serious events

Other events: 1 other events

Deaths: 0 deaths

7.5% Hypertonic Saline (HS)

Serious events: 25 serious events

Other events: 1 other events

Deaths: 0 deaths

0.9% Normal Saline

Serious events: 21 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=220 participants at risk 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=256 participants at risk 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=376 participants at risk 0.9% normal saline 250 ml dose as placebo
Blood and lymphatic system disorders Hypernatremia that required therapeutic intervention	0.91% 2/220 • Number of events 2 • Between May 2006 and August 2009, which was 3 years and 3 months 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	2.0% 5/256 • Number of events 5 • Between May 2006 and August 2009, which was 3 years and 3 months 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	1.3% 5/376 • Number of events 5 • Between May 2006 and August 2009, which was 3 years and 3 months 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
Nervous system disorders Increased intracranial hemorrrhage	5.5% 12/220 • Number of events 12 • Between May 2006 and August 2009, which was 3 years and 3 months 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	5.5% 14/256 • Number of events 14 • Between May 2006 and August 2009, which was 3 years and 3 months 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	4.0% 15/376 • Number of events 15 • Between May 2006 and August 2009, which was 3 years and 3 months 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
Blood and lymphatic system disorders Hypernatremia that did not required therapeutic intervention	3.2% 7/220 • Number of events 7 • Between May 2006 and August 2009, which was 3 years and 3 months 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	2.3% 6/256 • Number of events 6 • Between May 2006 and August 2009, which was 3 years and 3 months 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	0.27% 1/376 • Number of events 1 • Between May 2006 and August 2009, which was 3 years and 3 months 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

Other adverse events

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n=220 participants at risk 7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml	7.5% Hypertonic Saline (HS) n=256 participants at risk 7.5% hypertonic saline (HS) 250ml dose	0.9% Normal Saline n=376 participants at risk 0.9% normal saline 250 ml dose as placebo
Blood and lymphatic system disorders Pain, rash, hypotension secondary to a transfusion reaction	0.00% 0/220 • Between May 2006 and August 2009, which was 3 years and 3 months 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	0.00% 0/256 • Between May 2006 and August 2009, which was 3 years and 3 months 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	0.27% 1/376 • Number of events 1 • Between May 2006 and August 2009, which was 3 years and 3 months 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
Pregnancy, puerperium and perinatal conditions Complete placental abruption leading to fetal demise	0.00% 0/220 • Between May 2006 and August 2009, which was 3 years and 3 months 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	0.39% 1/256 • Number of events 1 • Between May 2006 and August 2009, which was 3 years and 3 months 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	0.00% 0/376 • Between May 2006 and August 2009, which was 3 years and 3 months 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
Nervous system disorders Seizure activity	0.45% 1/220 • Number of events 1 • Between May 2006 and August 2009, which was 3 years and 3 months 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	0.00% 0/256 • Between May 2006 and August 2009, which was 3 years and 3 months 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	0.00% 0/376 • Between May 2006 and August 2009, which was 3 years and 3 months 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

Additional Information

Susanne May, PhD

Clinical Trial Center, University of Washington, Seattle, WA

Phone: 206-685-1302

Email: sjmay@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place