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Effects Of Fish Oil Emulsion On Severe Acute Pancreatitis Patients

NCT01745861 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-12-10

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • University Hospitals, Leicester

    lead OTHER

Principal Investigators

  • Mr. Ashley Dennison, MD FRCS · Leicester General Hospital, University Hospitals of Leicester NHS Trust

  • Matthew Metcalfe, MD FRCS · Leicester General Hospital, University Hospitals of Leicester NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01745861 on ClinicalTrials.gov