- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Leicestershire
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Leicester, Leicestershire, United Kingdom, LE5 4PW
- Leicester General Hospital, University Hospitals of Leicester NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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)
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Lipidem 200 mg/ml daily infusion for 7 days maximum
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Placebo Comparator: Lipofundin® MCT/LCT 20%
Lipid emulsion containing medium and long chain triglycerides
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Lipofundin® MCT/LCT 20% daily infusion for 7 days
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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
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Day 7 post infusion
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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
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On days 1, 2, 3, 5 and 7 post infusion
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Progression in the Multiple Organ Dysfunction Score (MODS)
Time Frame: On days 1, 2, 3, 5 and 7 post infusion
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On days 1, 2, 3, 5 and 7 post infusion
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Progression in the Systemic Inflammatory Response Syndrome
Time Frame: On days 1, 2, 3, 5 and 7 post infusion
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On days 1, 2, 3, 5 and 7 post infusion
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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
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On days 1, 2, 3, 5 and 7 post infusion
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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
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On days 1, 2, 3, 5 and 7 post infusion
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Collaborators and Investigators
Sponsor
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
General Publications
- Morlion BJ, Torwesten E, Lessire H, Sturm G, Peskar BM, Furst P, Puchstein C. The effect of parenteral fish oil on leukocyte membrane fatty acid composition and leukotriene-synthesizing capacity in patients with postoperative trauma. Metabolism. 1996 Oct;45(10):1208-13. doi: 10.1016/s0026-0495(96)90237-1.
- Serhan CN, Clish CB, Brannon J, Colgan SP, Chiang N, Gronert K. Novel functional sets of lipid-derived mediators with antiinflammatory actions generated from omega-3 fatty acids via cyclooxygenase 2-nonsteroidal antiinflammatory drugs and transcellular processing. J Exp Med. 2000 Oct 16;192(8):1197-204. doi: 10.1084/jem.192.8.1197.
- Foitzik T, Eibl G, Schneider P, Wenger FA, Jacobi CA, Buhr HJ. Omega-3 fatty acid supplementation increases anti-inflammatory cytokines and attenuates systemic disease sequelae in experimental pancreatitis. JPEN J Parenter Enteral Nutr. 2002 Nov-Dec;26(6):351-6. doi: 10.1177/0148607102026006351.
- Hardman WE. (n-3) fatty acids and cancer therapy. J Nutr. 2004 Dec;134(12 Suppl):3427S-3430S. doi: 10.1093/jn/134.12.3427S.
- Roulet M, Frascarolo P, Pilet M, Chapuis G. Effects of intravenously infused fish oil on platelet fatty acid phospholipid composition and on platelet function in postoperative trauma. JPEN J Parenter Enteral Nutr. 1997 Sep-Oct;21(5):296-301. doi: 10.1177/0148607197021005296.
- Lee TH, Hoover RL, Williams JD, Sperling RI, Ravalese J 3rd, Spur BW, Robinson DR, Corey EJ, Lewis RA, Austen KF. Effect of dietary enrichment with eicosapentaenoic and docosahexaenoic acids on in vitro neutrophil and monocyte leukotriene generation and neutrophil function. N Engl J Med. 1985 May 9;312(19):1217-24. doi: 10.1056/NEJM198505093121903.
- Al-Leswas D, Eltweri AM, Chung WY, Arshad A, Stephenson JA, Al-Taan O, Pollard C, Fisk HL, Calder PC, Garcea G, Metcalfe MS, Dennison AR. Intravenous omega-3 fatty acids are associated with better clinical outcome and less inflammation in patients with predicted severe acute pancreatitis: A randomised double blind controlled trial. Clin Nutr. 2020 Sep;39(9):2711-2719. doi: 10.1016/j.clnu.2018.04.003. Epub 2018 Apr 27.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAP version 3 26-05-2011
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