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METHYLPREDNISOLONE INFUSION IN PATIENTS WITH EARLY ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) SIGNIFICANTLY IMPROVES LUNG FUNCTION: RESULTS OF A RANDOMIZED CONTROLLED TRIAL (RCT)

University of Tennessee Health Science Center, Memphis, TN

PURPOSE: To determine the effects of prolonged methylprednisolone infusion (PMPI) in patients with early ARDS.

METHODS: Patients were stratified by medical and surgical ARDS. Treatment: methylprednisolone (MP) loading 1 mg/kg I.V. was followed by PMPI at 1 mg/kg/day (days 1-14), 0.5 mg/kg/day (days 15-21), 0.25 mg/kg/day (days 22-25), and 0.125 mg/kg/day (days 26-28). Patients failing to improve lung injury score (LIS) by study day 7-9(unresolving ARDS) received open label MP (2mg/kg/day) treatment as previously reported (JAMA 1998; 280: 159). Infection surveillance and avoidance of paralysis were integral components of the protocol. The primary end-point to terminate the study was a 1-point reduction in lung injury score (LIS) by study day 7.

RESULTS: 91 patients entered the study (intention to treat - ITT)and 79 were eligible for analysis (55 treated and 24 control) on study day 7.The two groups had similar characteristics at study entry (Table 1). By day 7 (Table 2), the response of the two groups clearly diverged with almost twice the proportion of treated patients achieving a1-point reduction in LIS (69.8% vs. 37.5%; P = 0.002)and about 50%more treated patients breathing without assistance (53.9% vs. 25.0%; P = 0.01). Treated patients had a significant reduction in C-reactive protein levels and by day 7 had significantly lower LIS and multiple organ dysfunction syndrome (MODS) score. Treatment was associated with a reduction in the duration of MV, ICU staynd ICU mortality. The treatment group developed more frequently hyperglycemia (52.5% vs. 28.6%; P = 0.06), and polyneuropathy (2 vs. 0). Among treated patients, infection surveillance identified most nosocomial infections (65%) in the absence of fever.

CONCLUSION: PMPI was associated with significantly improved lung function and reduced duration of mechanical ventilation. These findings are consistent with the effects of prolonged glucocorticoid treatment previously reported in patients with unresolving ARDS (2 RCTs)and severe community-acquired pneumonia (AJRCCM 2005; 171; 242-248).

CLINICAL IMPLICATIONS: The findings of this study support the use of PMPI in association with infection surveillance and avoidance of paralysis in patients with ARDS.
Table 1— Baseline Characteristics

Variable Methylpr. Placebo P value No. of Patients 55 24 Age, years * 49.6 53.3 0.34 Male gender (%)# 30 (54.6) 11 (45.8) 0.48 APACHE III score ICU entry 58.9 55.0 0.43 APACHE III score study entry 57.6 62.8 0.28 Direct cause of ARDS (%) 40 (72.7) 14 (58.3) 0.21 Sepsis-induced ARDS (%) 42 (76.4) 22 (91.7) 0.13 Presence of Shock (%) 11 (20.0) 8 (33.3) 0.20 Lung Injury Score 3.23 3.14 0.44 PaO2:FiO2 117.4 129.2 0.52 MODS score 1.91 1.92 0.96 C-reactive protein 27.4 25.9 0.33

DISCLOSURE: Gianfranco Meduri, None.