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Methylprednisolone infusion in early severe ARDS: results of a randomized controlled trial
G Umberto Meduri1, Emmel Golden, Amado X Freire
1Division of Pulmonary, Critical Care, and Sleep Medicine, University of Tennessee Health Science Center, 956 Court Ave, Room H316, Memphis, TN 38163, USA. umeduri@utmem.edu
Objective:
To determine the effects of low-dose prolonged methylprednisolone infusion on lung function in patients with early severe ARDS.
Design:
Randomized, double-blind, placebo-controlled trial.
Setting:
ICUs of five hospitals in Memphis.
Participants:
Ninety-one patients with severe early ARDS (
Interventions:
Patients were randomized (2:1 fashion) to methylprednisolone infusion (1 mg/kg/d) vs placebo. The duration of treatment was up to 28 days. Infection surveillance and avoidance of paralysis were integral components of the protocol.
Main Outcome Measure:
The predefined primary end point was a 1-point reduction in lung injury score (LIS) or successful extubation by day 7.
Results:
In intention-to-treat analysis, the response of the two groups (63 treated and 28 control) clearly diverged by day 7, with twice the proportion of treated patients achieving a 1-point reduction in LIS (69.8% vs 35.7%; p = 0.002) and breathing without assistance (53.9% vs 25.0%; p = 0.01). Treated patients had significant reduction in C-reactive protein levels, and by day 7 had lower LIS and multiple organ dysfunction syndrome scores. Treatment was associated with a reduction in the duration of mechanical ventilation (p = 0.002), ICU stay (p = 0.007), and ICU mortality (20.6% vs 42.9%; p = 0.03). Treated patients had a lower rate of infections (p = 0.0002), and infection surveillance identified 56% of nosocomial infections in patients without fever.
Conclusions:
Methylprednisolone-induced down-regulation of systemic inflammation was associated with significant improvement in pulmonary and extrapulmonary organ dysfunction and reduction in duration of mechanical ventilation and ICU length of stay.
Insights
Low-dose methylprednisolone significantly improved lung function and reduced mortality in early severe acute respiratory distress syndrome (ARDS) patients. This treatment lowered mechanical ventilation duration and intensive care unit (ICU) stay, demonstrating its efficacy in critical care settings.
Area of Science:
- Critical Care Medicine
- Pulmonology
- Pharmacology
Background:
- Severe acute respiratory distress syndrome (ARDS) presents a significant challenge in intensive care units (ICUs).
- Systemic inflammation plays a crucial role in the pathophysiology and progression of ARDS.
- Early intervention strategies are vital for improving patient outcomes.
Purpose of the Study:
- To evaluate the efficacy of low-dose, prolonged methylprednisolone infusion in patients with early severe ARDS.
- To assess the impact of methylprednisolone on lung function, organ dysfunction, and clinical outcomes.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted across five hospital ICUs.
- Ninety-one patients with severe early ARDS (within 72 hours of onset) were enrolled, with 66% having sepsis.
- Patients received either methylprednisolone (1 mg/kg/d) or placebo infusion for up to 28 days, with rigorous infection surveillance.
Main Results:
- Methylprednisolone treatment led to a significantly higher proportion of patients achieving a 1-point reduction in Lung Injury Score (LIS) or successful extubation by day 7 (69.8% vs 35.7%).
- Treated patients showed reduced C-reactive protein levels, lower LIS and multiple organ dysfunction syndrome scores by day 7.
- Significant reductions were observed in mechanical ventilation duration (p=0.002), ICU stay (p=0.007), and ICU mortality (20.6% vs 42.9%; p=0.03).
- A lower rate of infections was noted in the methylprednisolone group (p=0.0002).
Conclusions:
- Low-dose methylprednisolone effectively down-regulates systemic inflammation in early severe ARDS.
- Treatment is associated with improved pulmonary and extrapulmonary organ function.
- Methylprednisolone infusion reduces mechanical ventilation duration, ICU length of stay, and mortality in ARDS patients.
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