Author Year

Country

Research Design

PEDro

Sample Size

Baker et al. (2009)

Canada

RCT

PEDro=10

N=64

Population: TBI; Hypertonic Saline (HTS, n=33):  Mean Age=42.3 yr; Gender: Male=23, Female=10; Mean GCS=5.8. Hypertonic Saline and Dextran (HSD, n=31): Mean Age=42.5 yr; Gender: Male=18, Female=13; Mean GCS=5.2.

Intervention: Participants were randomized to receive intravenous infusions of 0.9% HTS (250mL) or 7.5% HTS (250 mL) with 6% dextran-70 (HSD). Outcomes were assessed during the first 48 hr and at discharge.

Outcome Measures: Glasgow Outcome Scale (GOS), GOS Extended (GOSE), Disability Rating Scale (DRS), Functional Independence Measure (FIM), Mortality, Biomarkers.

1.        There was no significant difference between groups in GOS, GOSE, DRS, FIM, or mortality.

2.        Peak levels of biomarkers were significantly correlated with unfavorable outcomes measured by the GOS and GOSE.

Myburgh et al. (2007)

Australia

RCT

PEDro=10

N=460

Population: TBI; Hypertonic Saline (HTS, n=229): Median Age=35 yr; Gender: Male=169, Female=60; Median GCS=7. Albumin (ALB, n=231): Median Age=37 yr; Gender: Male=179, Female=52; Median GCS=7.

Intervention: Participants were randomized to receive intravenous infusions of 0.9% HTS or 4% ALB. Outcomes were assessed at 24 mo.

Outcome Measures: Glasgow Outcome Scale Extended (GOSE), Mortality.

1.        At 24 mo, there was a significantly higher rate of mortality in ALB than HTS (33.2% versus 20.4%, RR=1.63, p=0.003).

2.        Among those with severe TBI (GCS<9), there was a significantly higher rate of mortality in ALB than HTS (41.8% versus 22.2%, RR=1.88, p<0.001).

3.        Among those with mild TBI (GCS=9-12), there was a lower rate of mortality in ALB than HTS, but it was not significant (16.0% versus 21.6%, RR=0.74, p=0.50).

4.        There were no significant differences in GOSE between groups.

Sayre et al. (1996)

USA

RCT

PEDro=7

N=41

Population: TBI; Mannitol (MAN, n=20): Mean Age=29yr; Gender: Male=19, Female=1; Mean GCS=7.1. Hypertonic Saline (HTS, n=21): Mean Age=27 yr; Gender: Male=20, Female=1; Mean GCS=6.4.

Intervention: Patients were randomized to receive either intravenous infusion of 20% MAN (5 mL/kg) or 0.9% HTS (5 mL/kg).

Outcome Measures: Systolic Blood Pressure (SBP), Mortality, Urine Output (UO), Serum Sodium.

1.        Mortality was 25% in MAN and 14% in HTS (p=0.38).

2.        Mean SBP was significantly lower in MAN than in HTS (116 mmHg versus 142 mmHg, p<0.003) 2 hr after admission; however, when all time periods were compared there was no overall difference between groups.

3.        UO was significantly greater (p<0.001) and serum sodium was significantly lower (p<0.00001)  in MAN compared with HTS.

USA

Case Control

N=205

Population: TBI; Mean Age=53.12 yr; Gender: Male=157, Female=48; Mean GCS=8.75.

Intervention: Participants who received hypertonic saline (HTS, n=96) or did not (n=109) were compared in retrospective analysis.

Outcome Measures: Infections, Length of Stay (LOS), Blood Pressure (BP), Deep Venous Thrombosis (DVT), Acute Kidney Injury (AKI), Neurological Benefits.

1.        After correction for GCS, pulmonary infections (p=0.001) and LOS (p=0.0048) were significantly higher in HTS patients.

2.        HTS did not result in increased BP, DVT, AKI or neurological benefits.

3.        HTS significantly increased the odds for all infections (p<0.05), most specifically pulmonary infections, in patients with GCS<8.