Preventing new infections while patients are sick in hospital with omega-3 fatty acids
| ISRCTN | ISRCTN11451475 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11451475 |
| IRAS number | 1008285 |
| Secondary identifying numbers | 158743 Sponsor EDGE reference, CPMS 59166 |
- Submission date
- 05/12/2024
- Registration date
- 11/03/2025
- Last edited
- 04/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Patients admitted to the critical care unit often end up having new infections while they are in hospital, which can be very serious. Omega-3 fatty acids, which are fish oil extracts, may be helpful in reducing the number of people that have new infections and possibly, reduce the length of hospital stay. However, we need to find the correct dose that can be given to these patients. This study will help us establish a dose that can be given to similar patients in future and build a case for future studies.
Who can participate?
Patients aged 18 years and over admitted to the Intensive Care Unit
What does the study involve?
Participants will be randomly allocated to receive either omega-3 fatty acids for 10 days, or standard care (no extra treatments).
What are the possible benefits and risks of participating?
We are not expecting any serious side effects to occur during this study. Omegaven has fish oil, is a licensed drug in the EU, and has been used safely in other groups, including healthy people, people with liver problems and children. Some patients have experienced vomiting or had a rash.
We cannot promise that there will be benefits, but we are trying to understand if giving patients Omegaven prevents them from getting serious infections while in hospital.
Where is the study run from?
The Royal London Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2022 to December 2026
Who is funding the study?
Fresenius Kabi (Germany)
Who is the main contact?
Prof. Zudin Puthucheary, z.puthucheary@qmul.ac.uk
Contact information
Public, Scientific, Principal Investigator
Adult Critical Care Unit
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
| Phone | +44 (0)20 35940351 |
|---|---|
| z.puthucheary@qmul.ac.uk |
Study information
| Study design | Single-centre randomized controlled dose-escalation trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Hospital-acquired Infection Prevention with Parenteral Omegaven (HIPPO) |
| Study acronym | HIPPO |
| Study objectives | Hospital-acquired infections (HAI) are new infections that are typically not present at admission and manifest 48 hours after hospital admission. Several studies have highlighted the potentially beneficial effects of using omega-3 FAs (fish oil) in critically ill patients to lower inflammation and suggest a significant reduction in nosocomial (hospital-acquired) infections may occur in patients receiving total parenteral (outside of the digestive tract) nutrition prepared with a lipid emulsion. However, the acceptable dose that needs to be administered and is tolerated by patients needs to be determined. This will be clarified in a dose-escalation randomised controlled trial. The inclusion of a control (standard care) group will provide information on the expected baseline levels of the outcomes. |
| Ethics approval(s) |
Approved 19/02/2025, London - Fulham Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; fulham.rec@hra.nhs.uk), ref: 24/LO/0914 |
| Health condition(s) or problem(s) studied | Prevention of hospital-acquired infection in adult, critically ill patients |
| Intervention | Following consent, the intervention will start within 48 hours of critical care admission and continue for 10 days or until hospital discharge, whichever is sooner. Randomisation will be performed using an electronic randomisation system embedded within the online trial database. Intervention arm: Participants will be randomised sequentially in three dosing phases (0.2, 0.4, 0.6 g/kg/d Omegaven) according to the Bayesian Optimal Interval dose-escalation plan. Omegaven will be provided based on bodyweight in kg, except in cases of morbidly obese patients (actual bodyweight >200% of the ideal bodyweight). Patients will receive intravenous Omegaven, administered daily (at any time within a 24-hour period) until day 10 or hospital discharge, whichever is sooner. Omegaven will be administered centrally if available and if this is not possible it will be given peripherally. Standard care arm: Patients in the standard care group will be managed by clinical staff according to local policy and guidelines until hospital discharge. No additional interventions will occur. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacodynamic, Dose response |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Omegaven |
| Primary outcome measure | The maximum tolerable dose (MTD) of Omegaven, calculated after the completion of the dose escalation based on the dose-limiting toxicity, which is in turn based on a review of adverse events attributable to the IMP |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 06/01/2022 |
| Completion date | 15/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 110 Years |
| Sex | Both |
| Target number of participants | 36 |
| Key inclusion criteria | 1. Patients aged 18 years and over 2. Patients requiring intubation and ventilation OR requiring two or more other organ systems support (Sequential Organ Failure Assessment [SOFA] score ≥2 in >2 domains) without requiring intubation and ventilation 3. Patients predicted to remain in the critical care unit for at least 72 hours as determined by the Intensive Care Consultant with clinical responsibility for patient care |
| Key exclusion criteria | 1. Patients requiring total parenteral nutrition at time of enrolment 2. Palliative care admission for end-of-life care or withdrawal of active therapy as determined by the Intensive Care Consultant with clinical responsibility for patient care 3. Neutropaenia (<1 x 10^9/l) on admission to the Adult Critical Care Unit 4. Lymphopenia (<0.25 x 10^9/l) on admission to the Adult Critical Care Unit 5. Primary immune deficiency 6. Bone marrow transplant recipient 7. All immunosuppressive drug therapy (with the exception of corticosteroid use for acute illnesses in the preceding 5 days) 8. Recorded or reported allergy to fish, or egg protein or to any of the active ingredients or excipients 9. Known inborn errors of lipid metabolism 10. Recorded or reported severe hyperlipidaemia or severe disorders of lipid metabolism (electronic health record documentation ± clinical concern and if available with serum triglycerides >400 mg/dl on admission to the Adult Critical Care Unit) 11. Enrolment in any other study with an IMP or a study that may have a similar primary outcome 12. Therapeutic anti-coagulation therapy 13. Pregnancy |
| Date of first enrolment | 01/08/2025 |
| Date of final enrolment | 01/05/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
80 Newark Street
London
E1 2ES
United Kingdom
Sponsor information
University/education
Research Services, Dept. W
c/o Mile End Post Room
Queen Mary University of London
327 Mile End Road
London
E1 4NS
England
United Kingdom
| Phone | +44 (0)20 7882 7275 |
|---|---|
| research.governance@qmul.ac.uk | |
| Website | http://www.qmul.ac.uk/ |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Fresenius Kabi AG, Fresenius Kabi Deutschland GmbH
- Location
- Germany
Results and Publications
| Intention to publish date | 15/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Data arising from this research will be made available to the scientific community in a timely and responsible manner. A detailed scientific report will be submitted to a widely accessible scientific journal on behalf of the HIPPO Trial Group. The trial steering committee will agree on the membership of a writing committee, which will take primary responsibility for the final data analysis and writing of the scientific report. All members of the writing committee will comply with internationally agreed requirements for authorship and will approve the final manuscript prior to submission. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
04/06/2025: The recruitment start date was changed from 01/05/2025 to 01/08/2025.
01/04/2025: Internal review.
22/02/2025: ISRCTN received notification of combined HRA/MHRA approval for this trial on 22/02/2025.
05/12/2024: Trial's existence confirmed by NHS HRA.
