The primary outcome is the proportion of patients who develop MODS (new MODS), or in whom MODS worsens (progressive MODS) by one or more organ dysfunction(s), as defined by Proulx et al1, with minor modifications.
NPMODS will be monitored up to 28 days or upon death or discharge which ever comes first. We selected a 28 day limit because NPMODS is only rarely observed beyond this period.
MODS (termed multiple-organ-dysfunction syndrome) is defined as the concurrent dysfunction of two or more organ systems. Each organ system failure or dysfunction is defined according to the criteria in Proulx, with minor modifications.
New MODS is defined as follows: For patients with no organ dysfunction at the time of randomization, the development of two or more concurrent organ dysfunctions at any time during the 28 days after randomization. For patients with one organ dysfunction at the time of randomization, the development of at least one other concurrent organ dysfunction after the time of randomization.
Progressive MODS is defined as: at least one additional concurrent organ dysfunction at any time during the 28 days after randomization in a patient who already has MODS (i.e. concurrent dysfunction of two or more organ systems) at the time of randomization. All deaths will be categorized as progressive MODS.
1. Proulx F, Joyal JS, Mariscalco MM, Leteurtre S, Leclerc F, Lacroix J. The pediatric multiple organ dysfunction syndrome. Pediatr Crit Care Med 2009;10:12-22.