Effects Of Fish Oil Emulsion On Severe Acute Pancreatitis Patients
Condition: Assess Effect of Omega-3 Fish Oil in Patients With Severe Acute Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The incidence of acute pancreatitis in UK has risen sharply over the past 40 years. Recent
      reports suggest that 56.5 per 100 000 of the population will suffer from AP annually; this
      figure is more than double the highest previous estimated incidence. In the majority of
      patients the condition is mild, but about 25% of patients suffer a severe attack and between
      30 and 50% of these patients dies. The usual cause of death is multiple organ failure
      secondary to systemic leukocyte activation (mainly neutrophils), accompanied by the systemic
      inflammatory response syndrome (SIRS).

      Studies with omega-3 fish oil have shown to control inflammatory process and improve the
      outcome especially in hyperinflammatory conditions.

      This research will look at the effects of supplementing omega-3 fish oil to patients with
      severe acute pancreatitis (severe inflammation of the pancreas).

      Patients with severe acute pancreatitis will be prospectively and blindly randomised into
      either a study group who will receive (Lipidem, lipid emulsion contains essential fatty acids
      and omega-3 fish oil) or a control group that will receive (Lipofundin, lipid emulsion
      contains only essential fatty acids and no omega-3 fish oil). Normal and standard clinical
      care will be provided to all patients as per the national management guidelines. Each patient
      will receive either Lipidem or Lipofundin emulsions daily until they are deemed fit for
      discharge by their own medical team or for a maximum of SEVEN days.

      The main aim of this study is to examine whether lipid emulsions enriched with omega-3 fish
      oil could improve the clinical outcome in patients with severe acute pancreatitis.
    

Detailed description: 
      This research project is designed to give lipid emulsion enriched with omega-3 fish oil to
      conscious adult patients with mental capacity to consent for themselves and with severe acute
      pancreatitis in Leicester General Hospital wards or units.

      Potential participants with SAP will be identified by the patient's own team and referred to
      the researchers for consideration and eventual enrolling in the study. Unconscious patients
      or unable to consent for themselves will be EXCLUDED from the study.

      Randomization:

      Patients will be randomised to receive Lipidem 200 mg/ml OR Lipofundin MCT/LCT 20% lipid
      emulsion from random number tables. Randomization, blinding procedure (over labeling) will be
      conducted by an independent licensed pharmaceutical unit.
    

Intervention name(s): Lipidem (Omega-3 fish oil lipid emulsion); Lipofundin® MCT/LCT 20%
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lipidem 200 mg/ml daily infusion for 7 days maximum; Lipofundin® MCT/LCT 20% daily infusion for 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment