Protocol for a multicenter prospective observational study to develop and validate a cytokine-based prediction model for early warning of MODS after major trauma: the CYTO-MODS study

Purpose Severe trauma is a major cause of death and disability. Among its complications, multiple organ dysfunction syndrome (MODS) is a key late-stage condition, which is closely associated with post-traumatic cytokine storm. At present, there is a lack of reliable models for effective prediction of MODS, and the understanding of the dynamic changes of post-traumatic cytokines remains limited. This study is primarily designed to develop a predictive model for post-traumatic MODS, with a secondary aim of characterizing the features of the post-traumatic cytokine storm. Methods This is a study protocol. A prospective, multicenter, observational longitudinal study was designed. A total of 600 patients with severe trauma who have an injury severity score > 15 will be enrolled. Serum samples will be collected at 4 time points: within 8 h, 24 h, 72 h, and 168 h after injury. The temporal changes of key cytokines including interleukin-18, interferon-γ–inducible protein 10, monocyte chemoattractant protein-1, eosinophil chemotactic protein, monocyte chemoattractant protein-4, C-X-C motif chemokine ligand 12, macrophage inflammatory protein-3α, interleukin-1 receptor antagonist, cystatin C and myeloid-related protein 8/myeloid-related protein 14 will be quantitatively analyzed. The primary outcome of the study is the occurrence of MODS. Based on this, a combined multi-factor prediction model will be established and verified, and the characteristics of post-traumatic cytokine storm will be systematically described. Discussion This multicenter prospective study will provide robust evidence for the development and validation of a cytokine-based model for early prediction of MODS after severe trauma and further clarify the temporal evolution of post-traumatic cytokine storm.