Low-dose compared to high-dose methylprednisolone in patients with Chronic Obstructive Pulmonary Disease exacerbation requiring invasive mechanical ventilation: a proposed randomized controlled trial

Abstract

Background: Systemic corticosteroids are widely used in management of acute exacerbations of chronic obstructive pulmonary disease (COPD). As dosage, route of administration and duration of treatment are not yet determined for patients undergoing invasive mechanical ventilation (MV), intensivists and pulmonologists face a dilemma between respiratory improvement and dose-related side effects of corticosteroids.

Aim: To assess to what extent 60mg compared to 240mg of intravenous (IV) methylprednisolone daily reduces ventilator-free days (VFD) in individuals presenting severe exacerbation of COPD requiring invasive MV.

Methods: Multicenter, randomized, controlled, double-blinded clinical trial with two parallel arms in five ICUs of tertiary centers in Brazil. Primary endpoint is VFD, i.e., the number of days between extubation and day 28 after study enrollment. Estimated final sample size is of 250 individuals.

Perspectives: Prevention of adverse effects related to high dose of corticosteroids might have a dramatic impact on patients’ general health and on hospital resources.