Prehospital Hypertonic Saline Resuscitation of Patients With Hypotension and Severe Traumatic Brain Injury: A Randomized Controlled Trial
2004
ContextPrehospital hypertonic saline (HTS) resuscitation of patients with traumatic
brain injury (TBI) may increase survival but whether HTS improves neurological
outcomes is unknown.ObjectiveTo determine whether prehospital resuscitation with intravenous HTS
improves long-term neurological outcome in patients with severe TBI compared
with resuscitation with conventional fluids.Design, Setting, and PatientsDouble-blind, randomized controlled trial of 229 patients with TBI who
were comatose (Glasgow Coma Scale score, <9) and hypotensive (systolic
blood pressure, <100 mm Hg). The patients were enrolled between December
14, 1998, and April 9, 2002, in Melbourne, Australia.InterventionsPatients were randomly assigned to receive a rapid intravenous infusion
of either 250 mL of 7.5% saline (n = 114) or 250 mL of Ringer's lactate solution
(n = 115; controls) in addition to conventional intravenous fluid and resuscitation
protocols administered by paramedics. Treatment allocation was concealed.Main Outcome MeasureNeurological function at 6 months, measured by the extended Glasgow
Outcome Score (GOSE).ResultsPrimary outcomes were obtained in 226 (99%) of 229 patients enrolled.
Baseline characteristics of the groups were equivalent. At hospital admission,
the mean serum sodium level was 149 mEq/L for HTS patients vs 141 mEq/L for
controls (P<.001). The proportion of patients
surviving to hospital discharge was similar in both groups (n = 63 [55%] for
HTS group and n = 57 [50%] for controls; P = .32);
at 6 months, survival rates were n = 62 (55%) in the HTS group and n = 53
(47%) in the control group (P = .23). At 6 months,
the median (interquartile range) GOSE was 5 (3-6) in the HTS group vs 5 (5-6)
in the control group (P = .45). There was no significant
difference between the groups in favorable outcomes (moderate disability and
good outcome survivors [GOSE of 5-8]) (risk ratio, 0.99; 95% confidence interval,
0.76-1.30; P = .96) or in any other measure of postinjury
neurological function.ConclusionIn this study, patients with hypotension and severe TBI who received
prehospital resuscitation with HTS had almost identical neurological function
6 months after injury as patients who received conventional fluid.
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