Fish OIL Optimal dosE Determination Study

Phase 2

Terminated

• Conditions: Sepsis
• Interventions: Dietary Supplement: 0.20 gm/kg fish oil; Dietary Supplement: 0.50 gm/kg fish oil

• Registration Number: NCT01146821
• Lead Sponsor: University Hospital Carl Gustav Carus

Brief 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.

Study Timeline

• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Study Start: 2013-10
• Status Verified: 2017-04
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Adult ICU patients
• Requiring invasive or non-invasive ventilation
• Clinical evidence of sepsis
• Presence of one or more organ failures

Exclusion Criteria

• >24 hours from admission to ICU to time of consent
• Low level of inflammatory cytokine (IL-6(qualitative assay <100 pg/ml)
• lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the first week)
• Immunocompromised (post-organ transplantation, HIV, neutropenic [<1000 PMN], steroids >20 mgs/day for 6 months).
• Chronic non-invasive ventilation (except if they become mechanically ventilated)
• Platelet count of < 30 GPt/L
• Pregnant patients. Urine/blood tests for pregnancy will be done on all women of childbearing age by each site as part of standard of ICU practice.
• Previous enrollment in this study
• Enrollment in other ICU intervention study
• Allergy to fish or fish oil (shellfish allergy not an exclusion criterion)
• Has already received enteral or IV omega-3 fatty acids during this hospitalization and current ICU admission.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
standard care + 0.20gm/kg fish oil	0.20 gm/kg fish oil	standard care + 0.20gm/kg fish oil
standard care + 0.50 gm/kg fish oil	0.50 gm/kg fish oil	standard care + 0.50 gm/kg fish oil

Primary Outcome Measures

Name	Time	Method
Change in SOFA score	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).

Secondary Outcome Measures

Name	Time	Method
Clinical outcomes	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
Markers of systemic inflammation	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 \[TNF-α\]\].

Trial Locations

Locations (2)

University Hospital Giessen and Marburg; 🇩🇪 Giessen, Germany

University Hospital Dresden; 🇩🇪 Dresden, Germany