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.
Design: Retrospective analysis of a placebo-controlled, randomized, double-blind trial of low doses of corticosteroids in septic shock.
Setting: Nineteen intensive care units in France.
Patients: Among the 300 septic shock patients enrolled, we selected those meeting standard criteria for ARDS at inclusion.
Interventions: Seven-day treatment with 50 mg of hydrocortisone every 6 hrs and 50 μg of 9-α-fludrocortisone once a day.
Measurements and Main 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.
From 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 (DA); Laboratoire de Biostatistiques, Faculté de Pharmacie, Université de Nantes, Nantes, France (VS); and Centre d'Investigation Clinique INSERM 0203, Unité de Pharmacologie Clinique, Hôpital de Pontchaillou, Centre Hospitalier Universitaire de Rennes, Faculté de Médecine, Université de Rennes 1, Rennes, France (EB).
Supported, in part, by grant Ger-Inf-05R2 from GERMED, Assistance Publique–Hôpitaux de Paris, Paris, France.
None of the authors have financial disclosure or any other conflict of interest to disclose.
Address requests for reprints to: Djillali Annane, MD, PhD, Service de Réanimation Médicale, Hôpital Raymond Poincaré, 104 Boulevard Raymond Poincaré, 92380 Garches, France. E-mail: firstname.lastname@example.org.