Hospital-acquired Infection Prevention with Parenteral Omegaven (HIPPO)
Prevention of hospital-acquired infection in adult, critically ill patients
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.
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
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