Effects Of Fish Oil Emulsion On Severe Acute Pancreatitis Patients

NCT01745861 | Completed Phase 2

• 1 other identifier: SAP version 3 26-05-2011
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Reduction of the CRP by 20% from the control group

  Day 7 post infusion

Secondary Outcomes (5)

• Progression in the Sequential Organ Failure Assessment (SOFA) Score

  On days 1, 2, 3, 5 and 7 post infusion

• Progression in the Multiple Organ Dysfunction Score (MODS)

  On days 1, 2, 3, 5 and 7 post infusion

• Progression in the Systemic Inflammatory Response Syndrome

  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...).

  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

  On days 1, 2, 3, 5 and 7 post infusion

Study Arms (2)

Lipidem® (BBraun)

ACTIVE COMPARATOR

Lipid emulsion containing medium chain triglycerides (MCT), long chain triglyceride (LCT) and Omega-3 fatty acid (fish oil)

Dietary Supplement: Lipidem (Omega-3 fish oil lipid emulsion)

Lipofundin® MCT/LCT 20%

PLACEBO COMPARATOR

Lipid emulsion containing medium and long chain triglycerides

Dietary Supplement: Lipofundin® MCT/LCT 20%

Interventions

Lipidem (Omega-3 fish oil lipid emulsion) DIETARY_SUPPLEMENT

Lipidem 200 mg/ml daily infusion for 7 days maximum

Lipidem® (BBraun)

Lipofundin® MCT/LCT 20% DIETARY_SUPPLEMENT

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

Lipofundin® MCT/LCT 20%

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (1)

Leicester General Hospital, University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE5 4PW, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 12405646 BACKGROUND

• 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.

  PMID: 8843174 BACKGROUND

• 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.

  PMID: 15570049 BACKGROUND

• 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.

  PMID: 9323693 BACKGROUND

• 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.

  PMID: 11034610 BACKGROUND

• 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.

  PMID: 2985986 BACKGROUND

• 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.

  PMID: 32921364 DERIVED

Study Officials

• Mr. Ashley Dennison, MD FRCS

  Leicester General Hospital, University Hospitals of Leicester NHS Trust

  PRINCIPAL INVESTIGATOR

• Matthew Metcalfe, MD FRCS

  Leicester General Hospital, University Hospitals of Leicester NHS Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: December 10, 2012
• Study Start: June 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: December 10, 2012

Record last verified: 2012-12

Locations

GB (1)