Assess Effect of Omega-3 Fish Oil in Patients With Severe Acute Pancreatitis Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 44 |
| Est. completion date | February 2012 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Leicester General Hospital, University Hospitals of Leicester NHS Trust | Leicester | Leicestershire |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospitals, Leicester |
United Kingdom,
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Hardman WE. (n-3) fatty acids and cancer therapy. J Nutr. 2004 Dec;134(12 Suppl):3427S-3430S. Review. — View Citation
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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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reduction of the CRP by 20% from the control group | Day 7 post infusion | No | |
| Secondary | Progression in the Sequential Organ Failure Assessment (SOFA) Score | On days 1, 2, 3, 5 and 7 post infusion | No | |
| Secondary | Progression in the Multiple Organ Dysfunction Score (MODS) | On days 1, 2, 3, 5 and 7 post infusion | No | |
| Secondary | Progression in the Systemic Inflammatory Response Syndrome | On days 1, 2, 3, 5 and 7 post infusion | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No |