Sepsis Clinical Trial
Official title:
Multi-centre, Open-label, Phase II Clinical Trial for Determination of the Optimal Dose of Fish Oil in Patients With Severe Sepsis
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
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.
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