Completed

NCT Number: NCT01745861

Effects Of Fish Oil Emulsion On Severe Acute Pancreatitis Patients

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Leicester General Hospital, University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE5 4PW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Conscious patients between age of 18-90 admitted to the Leicester General hospital with severe acute pancreatitis proven by:

compatible clinical features (abdominal pain with or without vomiting);
associated with elevated serum amylase levels (≥3 normal value) (≥300 iu/l);
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

Treatment and study plan

Lipidem (Omega-3 fish oil lipid emulsion)

Dietary Supplement

Lipidem 200 mg/ml daily infusion for 7 days maximum

Lipofundin® MCT/LCT 20%

Dietary Supplement

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

Primary outcomes

Reduction of the CRP by 20% from the control group

Time frame: Day 7 post infusion

Secondary outcomes

Progression in the Sequential Organ Failure Assessment (SOFA) Score

Time frame: 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
Progression in the Systemic Inflammatory Response Syndrome

Time frame: 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
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

Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Dec 10, 2012
Registry last updated: Dec 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.