Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
7 participants
INTERVENTIONAL
2013-10-31
2017-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Standard care
Standard care
No interventions assigned to this group
standard care + 0.20gm/kg fish oil
standard care + 0.20gm/kg fish oil
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
standard care + 0.50 gm/kg fish oil
standard care + 0.50 gm/kg fish oil
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Requiring invasive or non-invasive ventilation
* Clinical evidence of sepsis
* Presence of one or more organ failures
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University of Giessen
OTHER
Clinical Evaluation Research Unit at Kingston General Hospital
OTHER
GWT-TUD GmbH
OTHER
University Hospital Carl Gustav Carus
OTHER
Responsible Party
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Axel R. Heller
MD
Principal Investigators
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Axel R. Heller, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Dresden, Germany
Daren Heyland, MD, PhD
Role: STUDY_CHAIR
Kingston General Hospital, Canada
Rupinder Dhaliwal, RD
Role: STUDY_DIRECTOR
Kingston General Hospital, Canada
Locations
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University Hospital Dresden
Dresden, , Germany
University Hospital Giessen and Marburg
Giessen, , Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2010-021018-49
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FK-FOILED
Identifier Type: -
Identifier Source: org_study_id
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