CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Lipidem (Omega-3 fish oil lipid emulsion) +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01745861
NCT01745861Phase 2Completed

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

University Hospitals, Leicester·interventional·Posted Dec 10, 2012·Updated Dec 10, 2012

In Brief

A Phase 2 clinical trial evaluating Lipidem (Omega-3 fish oil lipid emulsion) and Lipofundin® MCT/LCT 20% for Assess Effect of Omega-3 Fish Oil in Patients With Severe Acute Pancreatitis. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 10, 2012
Enrollment StartJun 1, 2010
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.6 years ago

Interventions

Lipidem (Omega-3 fish oil lipid emulsion)dietary

Lipidem 200 mg/ml daily infusion for 7 days maximum

Lipofundin® MCT/LCT 20%dietary

Lipofundin® MCT/LCT 20% daily infusion for 7 days