NCT01146821

Fish OIL Optimal dosE Determination Study

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University Hospital Carl Gustav Carus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	0.20 gm/kg fish oil	Group 2: 7 patients will receive 0.20gm/kg of ideal body weight \[IBW\] fish oil in addition to standard care
DIETARY_SUPPLEMENT	0.50 gm/kg fish oil	Group 3: 7 patients will receive 0.50 gm/kg of ideal body weight \[IBW\] fish oil in addition to standard care.

Timeline

• Start date: 2013-10-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2010-06-22
• Last updated: 2017-04-19

Locations

2 sites across 1 country: Germany