Effects Of Fish Oil Emulsion On Severe Acute Pancreatitis Patients
Effects Of Fish Oil Emulsion On Severe Acute Pancreatitis Patients
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.
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.
Inclusion Criteria:

 Conscious patients between age of 18-90 admitted to the Leicester General hospital with
 severe acute pancreatitis proven by:

 1. compatible clinical features (abdominal pain with or without vomiting);

 2. associated with elevated serum amylase levels (≥3 normal value) (≥300 iu/l);

 3. one or more of the severity criteria as outlined in the Atlanta severity criteria or
 modified glasgow acute pancreatitis severity score ≥3

 Exclusion Criteria:

 -  Patients unconscious or unable to consent.

 -  Patients under 18 years old or above 90 years old

 -  Hypersensitivity to fish, egg or soy protein or other active substances of the TPN.

 -  Uncontrolled hyperlipidaemia

 -  Severe primary blood coagulation disorder

 -  Acute pancreatitis accompanied with hyperlipidaemia

 -  Ketoacidosis

 -  Acute thromboembolic disease

 -  Severe liver failure

 -  Acute phase of myocardial infarction or stroke

 -  Pregnancy and lactation

 -  Severe renal failure without access to haemofiltration or dialysis