NCT01146821

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2 sepsis

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_2 sepsis

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
3.3 years until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

3.5 years

First QC Date

June 17, 2010

Last Update Submit

April 17, 2017

Conditions

Sepsis

Outcome Measures

Primary Outcomes (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).

    Day 1-10

Secondary Outcomes (2)

  • Markers of systemic inflammation

    Day 1-10

  • Clinical outcomes

    Day 1-28

Study Arms (3)

Standard care

NO INTERVENTION

Standard care

standard care + 0.20gm/kg fish oil

ACTIVE COMPARATOR

standard care + 0.20gm/kg fish oil

Dietary Supplement: 0.20 gm/kg fish oil

standard care + 0.50 gm/kg fish oil

ACTIVE COMPARATOR

standard care + 0.50 gm/kg fish oil

Dietary Supplement: 0.50 gm/kg fish oil

Interventions

0.20 gm/kg fish oilDIETARY_SUPPLEMENT

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

Also known as: Omegaven
standard care + 0.20gm/kg fish oil
0.50 gm/kg fish oilDIETARY_SUPPLEMENT

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

Also known as: Omegaven
standard care + 0.50 gm/kg fish oil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \>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
  • Has already received enteral or IV omega-3 fatty acids during this hospitalization and current ICU admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Dresden

Dresden, D-01307, Germany

Location

University Hospital Giessen and Marburg

Giessen, D-35392, Germany

Location

Related Publications (7)

  • 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.

    PMID: 23036226BACKGROUND

  • 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.

    PMID: 16484909BACKGROUND

  • 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.

    PMID: 15239141BACKGROUND

  • 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.

    PMID: 11895160BACKGROUND

  • 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.

    PMID: 12897994BACKGROUND

  • 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.

    PMID: 23609773BACKGROUND

  • 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.

    PMID: 24345520BACKGROUND

MeSH Terms

Conditions

Sepsis

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Axel R. Heller, MD

    University Hospital Dresden, Germany

    PRINCIPAL INVESTIGATOR

  • Daren Heyland, MD, PhD

    Kingston General Hospital, Canada

    STUDY CHAIR

  • Rupinder Dhaliwal, RD

    Kingston General Hospital, Canada

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 17, 2010

First Posted

June 22, 2010

Study Start

October 1, 2013

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations

DE(2)