Effects Of Fish Oil Emulsion On Severe Acute Pancreatitis Patients

December 7, 2012 updated by: University Hospitals, Leicester

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE5 4PW
        • Leicester General Hospital, University Hospitals of Leicester NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lipidem® (BBraun)
Lipid emulsion containing medium chain triglycerides (MCT), long chain triglyceride (LCT) and Omega-3 fatty acid (fish oil)
Lipidem 200 mg/ml daily infusion for 7 days maximum
Placebo Comparator: Lipofundin® MCT/LCT 20%
Lipid emulsion containing medium and long chain triglycerides
Lipofundin® MCT/LCT 20% daily infusion for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of the CRP by 20% from the control group
Time Frame: Day 7 post infusion
Day 7 post infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression in the Sequential Organ Failure Assessment (SOFA) Score
Time Frame: On days 1, 2, 3, 5 and 7 post infusion
On days 1, 2, 3, 5 and 7 post infusion
Progression in the Multiple Organ Dysfunction Score (MODS)
Time Frame: On days 1, 2, 3, 5 and 7 post infusion
On days 1, 2, 3, 5 and 7 post infusion
Progression in the Systemic Inflammatory Response Syndrome
Time Frame: On days 1, 2, 3, 5 and 7 post infusion
On days 1, 2, 3, 5 and 7 post infusion
Progression in the inflammatory and anti-inflammatory mediators (IL-1RA, IL-10, IL-6, IL-18, TNF-a, ICAM-1, IL-10 etc...).
Time Frame: On days 1, 2, 3, 5 and 7 post infusion
On days 1, 2, 3, 5 and 7 post infusion
Escalation of care to high dependency or intensive care unit and length of hospital stay
Time Frame: On days 1, 2, 3, 5 and 7 post infusion
On days 1, 2, 3, 5 and 7 post infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mr. Ashley Dennison, MD FRCS, Leicester General Hospital, University Hospitals of Leicester NHS Trust
  • Study Chair: Matthew Metcalfe, MD FRCS, Leicester General Hospital, University Hospitals of Leicester NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

December 7, 2012

First Posted (Estimate)

December 10, 2012

Study Record Updates

Last Update Posted (Estimate)

December 10, 2012

Last Update Submitted That Met QC Criteria

December 7, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • SAP version 3 26-05-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Assess Effect of Omega-3 Fish Oil in Patients With Severe Acute Pancreatitis

Clinical Trials on Lipidem (Omega-3 fish oil lipid emulsion)

3
Subscribe