Wednesday April 26, 2006
LATE STERIOD RESCUE STUDY (LaSRS): The Efficacy of Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome.
Finally the results of ARDSnet's LaSRS trial are published. Out of 180 patients with ARDS of atleast 7 days, 91 were randomly assigned to the placebo group and 89 to the methylprednisolone group. Some outcomes are very unexpected :
1. There was no significant difference in the 60-day hospital mortality rate, with 26 deaths in each group.
2. At 180 days, 29 patients had died in the placebo group and 28 had died in the methylprednisolone group.
3. The methylprednisolone group had significantly more ventilator-free days than the placebo group during the first 28 days as well as at 180 days.
4. As compared with the placebo group, the methylprednisolone group also had significantly fewer days in the ICU during the first 28 days but not at day 180 !!.
5. Ventilatory assistance was resumed: 6 in the placebo group and 20 in the methylprednisolone group. Also 8 of the 20 methylprednisolone-treated patients who resumed receiving assisted ventilation died, as compared with 3 of 6 patients in the placebo group.
6. The mean serum glucose level was not significantly different between groups at baseline but was significantly higher in the methylprednisolone group than the placebo group on days 1, 2, and 4.
7. Forty-three serious infections were diagnosed in 30 patients in the placebo group, as compared with 25 serious infections in 20 patients in the methylprednisolone group.
8. There were 17 episodes of septic shock among 15 patients in the placebo group and 6 episodes among 5 patients in the methylprednisolone group.
9. Prospectively, serious neuromyopathy were reported in nine patients, all of whom were in the methylprednisolone group but interestingly retrospective chart review found no significant difference in the incidence of neuromyopathy: 21 in the placebo group and 27 in the methylprednisolone group. Also, Exposure to neuromuscular-blocking agents was not significantly more common among patients who were identified as having neuromyopathy.
10. Patients who were enrolled at least 14 days after the onset of ARDS and who were randomly assigned to receive methylprednisolone had a significantly higher case fatality rate than similar patients who were assigned to receive placebo.
Study conclusion: These results do not support the routine use of methylprednisolone for persistent ARDS despite the improvement in cardiopulmonary physiology. In addition, starting steroid therapy more than two weeks after the onset of ARDS may increase the risk of death.
Editor note: Please read whole article to be aware of limitations of study.
1. Efficacy and Safety of Corticosteroids for Persistent Acute Respiratory Distress Syndrome - Volume 354:1671-1684, Number 16, April 20,2006
2. Protocol of study: ARDSnet.org
3. Late Steroid Rescue Study (LaSRS): The Efficacy of Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome - clinicaltrials.gov