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Fish OIL Optimal dosE Determination Study (FOILED)

Primary Purpose

Sepsis

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
0.20 gm/kg fish oil
0.50 gm/kg fish oil
Sponsored by
University Hospital Carl Gustav Carus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Dresden
  • University Hospital Giessen and Marburg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Standard care

standard care + 0.20gm/kg fish oil

standard care + 0.50 gm/kg fish oil

Arm Description

Standard care

standard care + 0.20gm/kg fish oil

standard care + 0.50 gm/kg fish oil

Outcomes

Primary Outcome Measures

Change in SOFA score
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

Markers of systemic inflammation
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
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

Full Information

First Posted
June 17, 2010
Last Updated
April 17, 2017
Sponsor
University Hospital Carl Gustav Carus
Collaborators
University of Giessen, Clinical Evaluation Research Unit at Kingston General Hospital, GWT-TUD GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01146821
Brief Title
Fish OIL Optimal dosE Determination Study
Acronym
FOILED
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 Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment/ expiration of the grant
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Carl Gustav Carus
Collaborators
University of Giessen, Clinical Evaluation Research Unit at Kingston General Hospital, GWT-TUD GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard care
Arm Title
standard care + 0.20gm/kg fish oil
Arm Type
Active Comparator
Arm Description
standard care + 0.20gm/kg fish oil
Arm Title
standard care + 0.50 gm/kg fish oil
Arm Type
Active Comparator
Arm Description
standard care + 0.50 gm/kg fish oil
Intervention Type
Dietary Supplement
Intervention Name(s)
0.20 gm/kg fish oil
Other Intervention Name(s)
Omegaven
Intervention Description
Group 2: 7 patients will receive 0.20gm/kg of ideal body weight [IBW] fish oil in addition to standard care
Intervention Type
Dietary Supplement
Intervention Name(s)
0.50 gm/kg fish oil
Other Intervention Name(s)
Omegaven
Intervention Description
Group 3: 7 patients will receive 0.50 gm/kg of ideal body weight [IBW] fish oil in addition to standard care.
Primary Outcome Measure Information:
Title
Change in SOFA score
Description
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).
Time Frame
Day 1-10
Secondary Outcome Measure Information:
Title
Markers of systemic inflammation
Description
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]].
Time Frame
Day 1-10
Title
Clinical outcomes
Description
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
Time Frame
Day 1-28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel R. Heller, MD
Organizational Affiliation
University Hospital Dresden, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daren Heyland, MD, PhD
Organizational Affiliation
Kingston General Hospital, Canada
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rupinder Dhaliwal, RD
Organizational Affiliation
Kingston General Hospital, Canada
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Dresden
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
University Hospital Giessen and Marburg
City
Giessen
ZIP/Postal Code
D-35392
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23036226
Citation
Pradelli L, Mayer K, Muscaritoli M, Heller AR. n-3 fatty acid-enriched parenteral nutrition regimens in elective surgical and ICU patients: a meta-analysis. Crit Care. 2012 Oct 4;16(5):R184. doi: 10.1186/cc11668. Erratum In: Crit Care. 2012;17(1):405.
Results Reference
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PubMed Identifier
16484909
Citation
Heller AR, Rossler S, Litz RJ, Stehr SN, Heller SC, Koch R, Koch T. Omega-3 fatty acids improve the diagnosis-related clinical outcome. Crit Care Med. 2006 Apr;34(4):972-9. doi: 10.1097/01.CCM.0000206309.83570.45.
Results Reference
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PubMed Identifier
15239141
Citation
Heller AR, Rossel T, Gottschlich B, Tiebel O, Menschikowski M, Litz RJ, Zimmermann T, Koch T. Omega-3 fatty acids improve liver and pancreas function in postoperative cancer patients. Int J Cancer. 2004 Sep 10;111(4):611-6. doi: 10.1002/ijc.20291.
Results Reference
background
PubMed Identifier
11895160
Citation
Heller AR, Fischer S, Rossel T, Geiger S, Siegert G, Ragaller M, Zimmermann T, Koch T. Impact of n-3 fatty acid supplemented parenteral nutrition on haemostasis patterns after major abdominal surgery. Br J Nutr. 2002 Jan;87 Suppl 1:S95-101. doi: 10.1079/bjn2001462.
Results Reference
background
PubMed Identifier
12897994
Citation
Mayer K, Fegbeutel C, Hattar K, Sibelius U, Kramer HJ, Heuer KU, Temmesfeld-Wollbruck B, Gokorsch S, Grimminger F, Seeger W. Omega-3 vs. omega-6 lipid emulsions exert differential influence on neutrophils in septic shock patients: impact on plasma fatty acids and lipid mediator generation. Intensive Care Med. 2003 Sep;29(9):1472-81. doi: 10.1007/s00134-003-1900-2. Epub 2003 Jul 25.
Results Reference
background
PubMed Identifier
23609773
Citation
Manzanares W, Dhaliwal R, Jurewitsch B, Stapleton RD, Jeejeebhoy KN, Heyland DK. Parenteral fish oil lipid emulsions in the critically ill: a systematic review and meta-analysis. JPEN J Parenter Enteral Nutr. 2014 Jan;38(1):20-8. doi: 10.1177/0148607113486006. Epub 2013 Apr 22.
Results Reference
background
PubMed Identifier
24345520
Citation
Pradelli L, Eandi M, Povero M, Mayer K, Muscaritoli M, Heller AR, Fries-Schaffner E. Cost-effectiveness of omega-3 fatty acid supplements in parenteral nutrition therapy in hospitals: a discrete event simulation model. Clin Nutr. 2014 Oct;33(5):785-92. doi: 10.1016/j.clnu.2013.11.016. Epub 2013 Dec 4.
Results Reference
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Fish OIL Optimal dosE Determination Study

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