Clinical Trial Results:
Fish OIL optimal dosE Determination Study
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Summary
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EudraCT number |
2010-021018-49 |
Trial protocol |
DE |
Global end of trial date |
15 Dec 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Jun 2024
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First version publication date |
06 Jun 2024
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
FOILED
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01146821 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GWT-TUD GmbH
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Sponsor organisation address |
Freiberger Str. 33, Dresden, Germany, 01067
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Public contact |
Medical Consulting, GWT-TUD GmbH, +49 35125933100, medical.consulting@g-wt.de
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Scientific contact |
Medical Consulting, GWT-TUD GmbH, +49 35125933100, medical.consulting@g-wt.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Jun 2018
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Dec 2017
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
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.
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Protection of trial subjects |
The conduct of this study was in compliance with the Good Clinical Praactice Guidelines and under the guiding principles detailed in the Declaration of Helsinki. The study was also carried out in keeping with applicable local law(s) and regulation(s).
Upon enrollment (prior to initiation of the study interventions) and daily thereafter for the study duration in the ICU, measurement daily parameters. In addition, monitoring routine measurements of liver function tests (AST, ALT, GGT, and bilirubin) and blood urea nitrogen when clinically available and will follow study patients in ICU to evaluate tolerance of enteral nutrition and total nutritional adequacy (including propofol use).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
12 Mar 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 7
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Worldwide total number of subjects |
7
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EEA total number of subjects |
7
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
7
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85 years and over |
0
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Recruitment
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Recruitment details |
The present trial enrolled patients from May 2012 and was preliminary stopped due to lack of recruitment after completion of the control group (n=7) in March 2017. The present trial was initially planned as a two-center open-label, phase II dose ranging clinical trial with prospective controls. | ||||||
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Pre-assignment
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Screening details |
Consecutive patients admitted to the ICU with sepsis were screened for possible enrollment in the trial. The first patient was enrolled in March 2015. | ||||||
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Period 1
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Period 1 title |
Group 1 (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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Group 1 | ||||||
Arm description |
A consecutive cohort of 7 patients who met the eligibility criteria serving as controls. This group received no fish oils but routine clinical and biochemical measurements were performed in this group similar to the subsequent groups. | ||||||
Arm type |
standard care | ||||||
Investigational medicinal product name |
Highly refined fish oil
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Investigational medicinal product code |
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Other name |
Omegaven®
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Pharmaceutical forms |
Emulsion for infusion
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Routes of administration |
Infusion
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Dosage and administration details |
No study intervention. This group received no fish oils but routine clinical and biochemical measurements were performed in this group similar to the subsequent groups.
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End points reporting groups
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Reporting group title |
Group 1
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Reporting group description |
A consecutive cohort of 7 patients who met the eligibility criteria serving as controls. This group received no fish oils but routine clinical and biochemical measurements were performed in this group similar to the subsequent groups. | ||
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End point title |
Change in Sequential Organ Failure Assessment score (organ function) [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
14 days
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The present trial enrolled patients from May 2012 and was preliminary stopped due to lack of recruitment after completion of the control group (n=7) in March 2017. Patients with severe sepsis and septic shock (initial SOFA 13±1). Caused mainly by peritonitis (85.7%). Hospital mortality was 28.6% and 28-day mortality 14.3%. ICU length of stay was 15 (6-36) days and hospital length of stay was 34 (14-69) days. |
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| No statistical analyses for this end point | |||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
12 month
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
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Reporting groups
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Reporting group title |
Overall
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Reporting group description |
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: There were no non-seroius adverse events reported. |
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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19 May 2015 |
Protocol V2.1 |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| The trial was stopped after completion of group 1 due to lack of recruitment. | |||
