Fish OIL Optimal dosE Determination Study

Sepsis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01146821
• Other study ID #: FK-FOILED
• Secondary ID: 2010-021018-49
• Status: Terminated
• Phase: Phase 2
• First received: June 17, 2010
• Last updated: April 17, 2017
• Start date: October 2013
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: University Hospital Carl Gustav Carus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 immunological parameters

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis

Intervention

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
• 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.

Locations

Country	Name	City	State
Germany	University Hospital Dresden	Dresden
Germany	University Hospital Giessen and Marburg	Giessen

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Carl Gustav Carus	Clinical Evaluation Research Unit at Kingston General Hospital, GWT-TUD GmbH, University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (7)

Heller AR, Fischer S, Rössel 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. — View Citation

Heller AR, Rössel 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. — View Citation

Heller AR, Rössler 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. — View 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. Review. — View Citation

Mayer K, Fegbeutel C, Hattar K, Sibelius U, Krämer HJ, Heuer KU, Temmesfeld-Wollbrück 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. Epub 2003 Jul 25. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day 1-10
Secondary	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-a]].	Day 1-10
Secondary	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	Day 1-28