Fish OIL Optimal dosE Determination Study (FOILED)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University Hospital Carl Gustav Carus.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
University Hospital Carl Gustav Carus
Collaborators:
University of Giessen
Clinical Evaluation Research Unit at Kingston General Hospital
Information provided by:
University Hospital Carl Gustav Carus
ClinicalTrials.gov Identifier:
NCT01146821
First received: June 17, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Sepsis |
Dietary Supplement: 0.20 gm/kg fish oil Dietary Supplement: 0.50 gm/kg fish oil |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multi-centre, Open-label, Phase I Clinical Trial for Determination of the Optimal Dose of Fish Oil in Patients With Severe Sepsis |
Resource links provided by NLM:
Further study details as provided by University Hospital Carl Gustav Carus:
Primary Outcome Measures:
- Change in SOFA score [ Time Frame: Day 1-10 ] [ Designated as safety issue: Yes ]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 [ Time Frame: Day 1-10 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 1-28 ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 21 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Standard care | |
| Active Comparator: standard care + 0.20gm/kg fish oil |
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
Other Name: Omegaven
|
| Active Comparator: standard care + 0.50 gm/kg fish oil |
Dietary Supplement: 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 Name: Omegaven
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146821
Contacts
| Contact: Axel R Heller, MD, PhD | +49 351 458 ext 2785 | axel.heller@uniklinikum-dresden.de |
| Contact: Rupinder Dhaliwal, RD | 613-549-6666 ext 3830 | dhaliwar@KGH.KARI.NET |
Locations
| Germany | |
| University Hospital Dresden | Not yet recruiting |
| Dresden, Germany, D-01307 | |
| Contact: Axel R. Heller, MD, PhD +49 351 458 ext 2785 axel.heller@uniklinikum-dresden.de | |
| Contact: Thea Koch, MD, PhD +49 351 458 ext 4000 thea.koch@uniklinikum-dresden.de | |
| Principal Investigator: Axel R. Heller, MD, PhD | |
| University Hospital Giessen and Marburg | Not yet recruiting |
| Giessen, Germany, D-35392 | |
| Contact: Konstantin Meyer, MD +49-641-99 ext 42112 Konstantin.Mayer@uglc.de | |
| Principal Investigator: Konstantin Meyer, MD | |
Sponsors and Collaborators
University Hospital Carl Gustav Carus
University of Giessen
Clinical Evaluation Research Unit at Kingston General Hospital
Investigators
| Principal Investigator: | Axel R. Heller, MD, PhD | University Hospital Dresden, Germany |
| Study Chair: | Daren Heyland, MD, PhD | Kingston General Hospital, Canada |
| Study Director: | Rupinder Dhaliwal, RD | Kingston General Hospital, Canada |
More Information
No publications provided
| Responsible Party: | Axel R. Heller MD, PhD, University Hospital Dresden |
| ClinicalTrials.gov Identifier: | NCT01146821 History of Changes |
| Other Study ID Numbers: | FK-FOILED, 2010-021018-49 |
| Study First Received: | June 17, 2010 |
| Last Updated: | June 17, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Sepsis Toxemia Infection |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013