Effects Of Fish Oil Emulsion On Severe Acute Pancreatitis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT01745861
First received: November 13, 2012
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Assess Effect of Omega-3 Fish Oil in Patients With Severe Acute Pancreatitis
Dietary Supplement: Lipidem (Omega-3 fish oil lipid emulsion)
Dietary Supplement: Lipofundin® MCT/LCT 20%
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial On The Effects Of Parenteral Fish Oil Emulsion In Patients With Severe Acute Pancreatitis

Resource links provided by NLM:


Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • Reduction of the CRP by 20% from the control group [ Time Frame: Day 7 post infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression in the Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: On days 1, 2, 3, 5 and 7 post infusion ] [ Designated as safety issue: No ]
  • Progression in the Multiple Organ Dysfunction Score (MODS) [ Time Frame: On days 1, 2, 3, 5 and 7 post infusion ] [ Designated as safety issue: No ]
  • Progression in the Systemic Inflammatory Response Syndrome [ Time Frame: On days 1, 2, 3, 5 and 7 post infusion ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: June 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lipidem® (BBraun)
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)
Lipidem 200 mg/ml daily infusion for 7 days maximum
Placebo Comparator: Lipofundin® MCT/LCT 20%
Lipid emulsion containing medium and long chain triglycerides
Dietary Supplement: Lipofundin® MCT/LCT 20%
Lipofundin® MCT/LCT 20% daily infusion for 7 days

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745861

Locations
United Kingdom
Leicester General Hospital, University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom, LE5 4PW
Sponsors and Collaborators
University Hospitals, Leicester
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
  More Information

Publications:

Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT01745861     History of Changes
Other Study ID Numbers: SAP version 3 26-05-2011
Study First Received: November 13, 2012
Last Updated: December 7, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Pancreatitis
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014