NCT01745861

Effects Of Fish Oil Emulsion On Severe Acute Pancreatitis Patients

Randomised Controlled Trial On The Effects Of Parenteral Fish Oil Emulsion In Patients With Severe Acute Pancreatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University Hospitals, Leicester · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Assess Effect of Omega-3 Fish Oil in Patients With Severe Acute Pancreatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lipidem (Omega-3 fish oil lipid emulsion)	Lipidem 200 mg/ml daily infusion for 7 days maximum
DIETARY_SUPPLEMENT	Lipofundin® MCT/LCT 20%	Lipofundin® MCT/LCT 20% daily infusion for 7 days

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-12-10
• Last updated: 2012-12-10

Locations

1 site across 1 country: United Kingdom