- Included 1084 patients ≥ 16 years of age with acute asthma exacerbations at 34 emergency departments in the United Kingdom. Patients with life-threatening features were excluded.
- Randomized patients to receive IV magnesium sulfate (2 gm over 20 min), nebulized magnesium sulfate (three 500 mg doses over 1 hour), or placebo. All other elements of asthma treatment were left to the discretion of the treating provider.
- Although the trial only met 92% of its planned enrollment for statistical power, it was still 83% powered to detect a 10% difference in the hospitalization primary endpoint
- Primary endpoint #1 (hospitalization within 7 days) was not different between IV magnesium, nebulized magnesium, or placebo (79% vs. 72% vs. 78%, p=0.276)
- Primary endpoint #2 (change in breathlessness on a 100 mm visual-analog scale at two hours) was not different between IV magnesium, nebulized magnesium, or placebo (-28.2 vs. -34.3 vs. -31.3 mm, p=0.999)
- Patients receiving either formulation of magnesium were more likely to experience side effects (IV 15% vs. nebulized 16% vs. placebo 10%, p=0.014). Hypotension, nausea/vomiting, and “other” side effects were more common with magnesium than placebo.
- Other secondary endpoints (peak expiratory flow at two hours, length of stay, need for mechanical ventilation) were not different between the three groups
“Among adults with acute asthma exacerbations, neither IV nor nebulized magnesium sulfate had any beneficial effect on clinical outcomes compared to placebo.”
- Included 798 patients diagnosed with severe sepsis within the past 24 hours
Randomized to HES 130/0.42 (Tetraspan) or lactated ringers (LR) as needed up to a maximum of 33 mL/kg/day, after which open-label LR was used.
- Primary endpoint (death or dialysis dependence at 90 days) was more common with HES than LR (51% vs. 43%, NNH 13, p=0.03) — driven entirely by mortality
- Interestingly, no difference in mortality was seen at 28 days between HES and LR (39% vs. 36%, p=0.43)
- Use of renal replacement therapy was more common with HES (22% vs. 16%, NNH 17, p=0.04)
- HES patients were more likely to receive blood products (RR 1.2, 95% CI 1.07-1.36, p=0.002); a trend toward severe bleeding was also seen with HES (10% vs. 6%, p=0.09)
- There was no difference between HES and LR in total blinded volume received within the first three days, indicating similar potency between the two fluids
“For patients with severe sepsis, hydroxyethyl starch (HES 130/0.42) was associated with higher 90-day mortality, need for renal replacement therapy, and the use of blood products than lactated ringers (LR).”