Assess Effect of Omega-3 Fish Oil in Patients With Severe Acute Pancreatitis Clinical Trial
Official title:
Randomised Controlled Trial On The Effects Of Parenteral Fish Oil Emulsion In Patients With Severe Acute Pancreatitis
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment