Prehospital Hypertonic Saline Resuscitation
This review may be edited
Posted By: Rahul Deshpande
Posted Date: 03/03/10
Title: Prehospital Hypertonic Saline Resuscitation
Authors: D. James Cooper, BMBS, MD; Paul S. Myles, MBBS, MD; Francis T. McDermott, MBBS, MD; Lynette J. Murray, BAppSci; John Laidlaw, MBBS; Gregory Cooper; Ann B. Tremayne; Stephen S. Bernard, MBBS; Jennie Ponsford, MA, PhD; for the HTS Study Investigators
Reference: JAMA. 2004;291:1350-1357
Link: Click here for a direct link to the paper. A password may be required for access to fulltext.
Abstract: Context Prehospital hypertonic saline (HTS) resuscitation of patients with traumatic brain injury (TBI) may increase survival but whether HTS improves neurological outcomes is unknown. Objective To 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 Patients Double-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. Interventions Patients were randomly assigned to receive a rapid intravenous infusion of either 250 mL of 7.5% saline (n=114) or 250 mL of Ringerís lactate solution (n=115; controls) in addition to conventional intravenous fluid and resuscitation protocols administered by paramedics. Treatment allocation was concealed. Main Outcome Measure Neurological function at 6 months, measured by the extended Glasgow Outcome Score (GOSE). Results Primary 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. Conclusion In 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.
Are the Results Valid?
1. Was the assignment of patients to treatments randomized? ( Was allocation concealment maintained?)
Yes. Allocation concealment was maintained by using sequentially numbered identical fluid bags (instead of sequentially numbered envelopes) in each Ambo to allocate new patients to one of the two treatment arms.
2. Were all patients who entered the trial properly accounted for and attributed at its conclusion?
2a. Was followup complete?
[Edited by Gord]Unclear. Figure 1 implies that follow-up was complete however the first paragraph of the Results section report that "A total of 262 patients were enrolled in the study, including 27 patients who were subsequently excluded because they did not fulfill study entry criteria." Furthermore, the text of the Results section refers to '229 correctly enrolled patients'.

It is likely that 11.4% (30/262)of all enrolled patients were excluded from analysis.

2b. Were patients analyzed in the groups to which they were randomized?
Yes they were.
3. Were patients, health workers, and study personnel blind to treatment?
Yes, Patients, paramedics, treating physicians, and study coordinators were all blinded to treatment received.
4. Were the groups similar at the start of the trial?
The authors report good balance for the 229 'correctly enrolled patients'.
5. Aside from the experimental intervention, were the groups treated equally?
Table 2 does suggest there were differences in treatments received. For example, Control patients required a longer duration of inotropes.
What are the Results?
1. How large was the treatment effect?
There were no significant differences between the groups with respect to the primary study end point, the GOSE, or other measures of functional neurological status (Table 3) at either 3 or 6 months after injury. There was also no difference in the rate of favorable outcome, defined by a GOSE of 5 or more, for HTS vs control (RR, 0.99; 95% CI, 0.76-1.30; P=.96). Rates of return to work were not significantly different between the groups.
2. How precise was the estimate of the treatment effect?
The proportion of patients surviving at 6 months was P=.23; RR, 1.17; 95% CI, 0.9-1.5).

Favorable outcome, defined by a GOSE of 5 or more, for HTS vs control (RR, 0.99; 95% CI, 0.76-1.30; P=.96).

Will the Results Help Me In Caring For My Patients?
1. Can the results be applied to my patient care?
The patient and abulance retrieval system is similar to that of NSW.
2. Were all clinically important outcomes considered?
Yes. The authors did a reasonably good job of collecting appropriate measures of quality of life: GOSE, Neurological outcome in 6 months.Return to Previous job vs Modified Job.
3. Are the likely treatment benefits worth the potential harms and costs?
Uncertain. With a possiblity of more than 10% of enrolled patient excluded from the primary analysis, significant uncertainty exists about the interpretation of the results.

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Prehospital Hypertonic Saline Resuscitation

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