Objectives: The overall objective is to determine the effect of IV fish oil on 28-day mortality of critically ill patients with severe sepsis. However, prior to such a large trial, we need to determine the optimal dose of IV fish oils in this population. Therefore, the primary objective of this proposal (FOILED) is to determine the safety and efficacy of IV fish oil doses of 0.20 g/kg and 0.50 g/kg, compared to a control group, in critically ill patients with severe sepsis by examining organ function, blood safety and biochemical parameters, markers of systemic inflammation and innate immunological parameters.~Study Design: This is a multi-centre, open-label, phase I dose ranging clinical trial with prospective controls.~Setting: 2 tertiary care ICUs in Germany (Universitätsklinikum Carl Gustav Carus, Dresden and University Hospital Giessen and Marburg, Giessen).~Patients: Mechanically ventilated adult patients (>18 years old) admitted to ICU with clinical evidence of sepsis, sepsis associated organ dysfunction, and high expression of inflammatory cytokines.
The primary objective of this trial is to determine the safety and efficacy of IV fish oil doses of 0.20 g/kg and 0.50 g/kg, compared to a control group, in critically ill patients with severe sepsis by examining organ function, blood safety and biochemical parameters, markers of systemic inflammation and innate immunological parameters