Fish OIL Optimal dosE Determination Study (FOILED)
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|ClinicalTrials.gov Identifier: NCT01146821|
Recruitment Status : Terminated (Low enrollment/ expiration of the grant)
First Posted : June 22, 2010
Last Update Posted : April 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sepsis||Dietary Supplement: 0.20 gm/kg fish oil Dietary Supplement: 0.50 gm/kg fish oil||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-centre, Open-label, Phase II Clinical Trial for Determination of the Optimal Dose of Fish Oil in Patients With Severe Sepsis|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
No Intervention: Standard care
Active Comparator: standard care + 0.20gm/kg fish oil
standard care + 0.20gm/kg fish oil
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
Other Name: Omegaven
Active Comparator: standard care + 0.50 gm/kg fish oil
standard care + 0.50 gm/kg fish oil
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.
Other Name: Omegaven
- Change in SOFA score [ Time Frame: Day 1-10 ]As the primary goal of this study is to establish the safety of high doses of IV fish oils, our primary outcomes will be change in SOFA score (organ function) and biochemical parameters of safety (i.e. blood lipid levels, coagulation parameters, bleeding episodes, standard biochemistry).
- Markers of systemic inflammation [ Time Frame: Day 1-10 ]Our secondary outcomes include markers of systemic inflammation [pro-calcitonin [PCT], C-reactive protein [CRP], interleukin-1 [IL-6] and IL-10) and markers of innate immunity [such as lipopolysaccharide [LPS] ex-vivo stimulation of tumor necrosis factor-alpha [TNF-α]].
- Clinical outcomes [ Time Frame: Day 1-28 ]In addition, we plan to collect clinical outcomes such as ICU and hospital length of stay, number of infections, length of ventilation, and ICU, 28-day, and hospital mortality rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146821
|University Hospital Dresden|
|Dresden, Germany, D-01307|
|University Hospital Giessen and Marburg|
|Giessen, Germany, D-35392|
|Principal Investigator:||Axel R. Heller, MD||University Hospital Dresden, Germany|
|Study Chair:||Daren Heyland, MD, PhD||Kingston General Hospital, Canada|
|Study Director:||Rupinder Dhaliwal, RD||Kingston General Hospital, Canada|