Effects Of Fish Oil Emulsion On Severe Acute Pancreatitis Patients
NCT ID: NCT01745861
Last Updated: 2012-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2010-06-30
2012-02-29
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lipidem® (BBraun)
Lipid emulsion containing medium chain triglycerides (MCT), long chain triglyceride (LCT) and Omega-3 fatty acid (fish oil)
Lipidem (Omega-3 fish oil lipid emulsion)
Lipidem 200 mg/ml daily infusion for 7 days maximum
Lipofundin® MCT/LCT 20%
Lipid emulsion containing medium and long chain triglycerides
Lipofundin® MCT/LCT 20%
Lipofundin® MCT/LCT 20% daily infusion for 7 days
Interventions
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Lipidem (Omega-3 fish oil lipid emulsion)
Lipidem 200 mg/ml daily infusion for 7 days maximum
Lipofundin® MCT/LCT 20%
Lipofundin® MCT/LCT 20% daily infusion for 7 days
Eligibility Criteria
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Inclusion Criteria
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 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
18 Years
90 Years
ALL
No
Sponsors
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University Hospitals, Leicester
OTHER
Responsible Party
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Principal Investigators
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Mr. Ashley Dennison, MD FRCS
Role: PRINCIPAL_INVESTIGATOR
Leicester General Hospital, University Hospitals of Leicester NHS Trust
Matthew Metcalfe, MD FRCS
Role: STUDY_CHAIR
Leicester General Hospital, University Hospitals of Leicester NHS Trust
Locations
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Leicester General Hospital, University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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SAP version 3 26-05-2011
Identifier Type: -
Identifier Source: org_study_id