Effect of low doses of corticosteroids in septic shock patients with or without early acute respiratory distress syndrome.
OBJECTIVE
We investigated the efficacy of low doses of corticosteroids in septic shock patients with or without early acute respiratory distress syndrome (ARDS) by post hoc analysis of a previously completed clinical trial.


METHODS
Retrospective analysis of a placebo-controlled, randomized, double-blind trial of low doses of corticosteroids in septic shock.


METHODS
Nineteen intensive care units in France.


METHODS
Among the 300 septic shock patients enrolled, we selected those meeting standard criteria for ARDS at inclusion.


METHODS
Seven-day treatment with 50 mg of hydrocortisone every 6 hrs and 50 microg of 9-alpha-fludrocortisone once a day.


RESULTS
There were 177 patients with ARDS (placebo, n = 92; corticosteroids, n = 85) including 129 (placebo, n = 67; corticosteroids, n = 62) nonresponders and 48 (placebo, n = 25; corticosteroids, n = 23) responders. In nonresponders, there were 50 deaths (75%) in the placebo group and 33 deaths (53%) in the steroid group (hazard ratio 0.57, 95% confidence interval 0.36-0.89, p = .013; relative risk 0.71, 95% confidence interval 0.54-0.94, p = .011). The number of days alive and off the ventilator was 2.6 +/- 6.6 in the placebo group and 5.7 +/- 8.6 in the steroid group (p = .006). There was no significant difference between groups in responders. There was no significant difference between groups in the two subsets of patients without ARDS. Adverse events rates were similar in the two groups.


CONCLUSIONS
This post hoc analysis shows that a 7-day treatment with low doses of corticosteroids was associated with better outcomes in septic shock-associated early ARDS nonresponders, but not in responders and not in septic shock patients without ARDS.
Annane
Djillali
D
Service de Réanimation Médicale, Hôpital Raymond Poincaré, Assistance Publique--Hôpitaux de Paris, Faculté de Médecine Paris Ile de France Ouest, Université de Versailles Saint-Quentin en Yvelines, Garches, France. djillali.annane@rpc.aphp.fr
Sébille
Véronique
V
Bellissant
Eric
E
D000328:Adult; D000368:Aged; D016638:Critical Illness; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005438:Fludrocortisone / Q000008:administration & dosage*; D005602:France; D049671:History, 18th Century; D017052:Hospital Mortality / Q000639:trends*; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage*; D007262:Infusions, Intravenous; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D011175:Positive-Pressure Respiration / Q000379:methods; D011336:Probability; D011379:Prognosis; D012016:Reference Values; D012128:Respiratory Distress Syndrome / Q000150:complications / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy; D012189:Retrospective Studies; D018570:Risk Assessment; D012772:Shock, Septic / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality*; D015996:Survival Rate; D016896:Treatment Outcome
D005438:Fludrocortisone; D006854:Hydrocortisone