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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
Sponsor:
Collaborators:
University of Giessen
Clinical Evaluation Research Unit at Kingston General Hospital
GWT-TUD GmbH
Information provided by (Responsible Party):
Axel R. Heller, 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

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
Drug Information available for: Fish oil

Arm Intervention/treatment
No Intervention: Standard care
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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]].

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
Germany
University Hospital Dresden
Dresden, Germany, D-01307
University Hospital Giessen and Marburg
Giessen, Germany, D-35392
Sponsors and Collaborators
University Hospital Carl Gustav Carus
University of Giessen
Clinical Evaluation Research Unit at Kingston General Hospital
GWT-TUD GmbH
Investigators
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

Publications:

Responsible Party: Axel R. Heller, MD, University Hospital Carl Gustav Carus
ClinicalTrials.gov Identifier: NCT01146821     History of Changes
Other Study ID Numbers: FK-FOILED
2010-021018-49 ( EudraCT Number )
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes