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SepsisPhase 2FOILEDNCT01146821

Fish OIL Optimal dosE Determination Study

A Phase 2 study testing 0.20 gm/kg fish oil and 0.50 gm/kg fish oil in people with Sepsis, run by University Hospital Carl Gustav Carus at 2 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis
What is being tested?
0.20 gm/kg fish oil and 0.50 gm/kg fish oil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
2 sitesGermany
Study dates
Oct 2013to Apr 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • >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
Show all 11Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • University Hospital Dresden

    Dresden, D-01307

  • University Hospital Giessen and Marburg

    Giessen, D-35392

Other trials in Germany

About this study

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

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

Read the 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
Being tested
0.20 gm/kg fish oil, 0.50 gm/kg fish oil
Medical subject headings
Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.20 gm/kg fish oilDietary supplement

    Also called Omegaven

    Group 2: 7 patients will receive 0.20gm/kg of ideal body weight [IBW] fish oil in addition to standard care

  • 0.50 gm/kg fish oilDietary supplement

    Also called Omegaven

    Group 3: 7 patients will receive 0.50 gm/kg of ideal body weight [IBW] fish oil in addition to standard care.

Study groups in NCT01146821
Study groupRoleWhat they receive
Standard careNo interventionStandard care
standard care + 0.20gm/kg fish oilActive comparatorstandard care + 0.20gm/kg fish oil
Receives: Dietary Supplement: 0.20 gm/kg fish oil
standard care + 0.50 gm/kg fish oilActive comparatorstandard care + 0.50 gm/kg fish oil
Receives: Dietary Supplement: 0.50 gm/kg fish oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Day 1-10

Secondary outcomes (2)

  1. 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]].

    Measured: Day 1-10

  2. 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

    Measured: Day 1-28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2010 (estimated)
  2. Study startOct 2013
  3. Primary completionApr 2017
  4. Study completionApr 2017

Why it stopped: Low enrollment/ expiration of the grant

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01146821
Sponsor's protocol ID
FK-FOILED
Other IDs
2010-021018-49
Acronym
FOILED
Status last verified
Apr 2017
First submitted
17 Jun 2010
Last updated
19 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23036226

  • 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.

    PubMed 16484909

  • 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.

    PubMed 15239141

  • 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.

    PubMed 11895160

  • 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.

    PubMed 12897994

  • 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.

    PubMed 23609773

  • 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.

    PubMed 24345520

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 0.20 gm/kg fish oil and 0.50 gm/kg fish oil in people with Sepsis, run by University Hospital Carl Gustav Carus at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low enrollment/ expiration of the grant). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in SOFA score (time frame: Day 1-10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01146821, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.

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