Effects of different doses of methylprednisolone on clinical outcomes in patients with severe community-acquired pneumonia: a study protocol for a randomized controlled trial
Abstract
Background The specific use of methylprednisolone in severe community-acquired pneumonia (SCAP) has not yet formed a consensus. It is not clear whether the clinical efficacy of methylprednisolone in SCAP is dose-dependent, and how to balance the best efficacy with the least complications. The aim of this study is to evaluate the efficacy and safety of different doses of methylprednisolone in the adjuvant treatment for patients with SCAP. Methods/design This is a prospective, randomized, double-blind, parallel group, placebo-controlled trial to evaluate the efficacy and safety of different doses of methylprednisolone in the adjuvant treatment for patients with SCAP. Patients with diagnosed SCAP are randomized to the following four groups at a 1:1:1:1 ratio: group 1 (control group)—standard ICU patient care+100ml of normal saline once a day for 5 days; group 2—standard ICU patient care+40mg of methylprednisolone (dissolved in normal saline with a final volume of 100ml) once a day for 5 days; group 3—standard ICU patient care+80mg of methylprednisolone (dissolved in normal saline with a final volume of 100ml) once a day for 5 days; and group 4—standard ICU patient care+120mg of methylprednisolone (dissolved in normal saline with a final volume of 100ml) once a day for 5 days. The primary outcome is PaO 2 /FiO 2 ratio at day 5 following randomization. The secondary outcomes are 28-day mortality, ventilator-free days at 28 days, mechanical ventilation duration at 28 days,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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