#1 Clinical Trials Search in Europe

Highly Refined Fish Oil

Highly Refined Fish Oil is emerging as a promising treatment in various medical conditions. This article explores two significant clinical trials investigating its use in cardiac surgery patients and those with severe acute pancreatitis. These studies aim to evaluate the potential benefits of fish oil in reducing complications and improving patient outcomes in critical care settings.

Table of Contents

What is Highly Refined Fish Oil?

Highly refined fish oil is a medical product derived from fish that contains high concentrations of omega-3 fatty acids. It is being studied as a potential treatment for various medical conditions, particularly in critically ill patients and those undergoing cardiac surgery[1][2]. This substance is often referred to as “long chain omega-3-fatty acids” in medical contexts.

Potential Benefits for Cardiac Surgery Patients

Research is being conducted to explore the potential benefits of highly refined fish oil for patients undergoing high-risk cardiac surgery. The primary focus is on its ability to prevent atrial fibrillation (an irregular and often rapid heart rate) after surgery[1]. Some potential benefits being studied include:

  • Prevention of atrial fibrillation up to 7 days after surgery
  • Enhanced recovery after cardiac surgery
  • Reduced time to discharge from the hospital
  • Improved organ function
  • Shorter stays in the intensive care unit (ICU) and hospital
  • Reduced need for mechanical ventilation
  • Lower incidence of stroke
  • Improved kidney function
  • Better overall survival rates

Potential Benefits for Acute Pancreatitis Patients

Another area of research is exploring the use of highly refined fish oil in patients with predicted severe acute pancreatitis. The main goal is to reduce organ failure and mortality in these patients[2]. Potential benefits being investigated include:

  • Reduction in new organ failure (cardiovascular, pulmonary, or renal)
  • Lower mortality rates
  • Fewer infectious complications
  • Reduced need for surgical, endoscopic, or radiologic interventions
  • Shorter hospital and ICU stays
  • Decreased levels of C-reactive protein (CRP), an indicator of inflammation

How is it Administered?

Highly refined fish oil is typically administered intravenously (through a vein) as an emulsion for infusion[1][2]. The dosage and duration of treatment may vary depending on the specific condition being treated and the individual patient’s needs. For example:

  • In cardiac surgery patients, it may be given at a dose of up to 200,000 μg/kg per day for up to 8 days[1].
  • In acute pancreatitis patients, it might be administered at 2 ml/kg/day for up to 7 days[2].

Who Can Receive This Treatment?

The use of highly refined fish oil is still being researched, and specific criteria determine who might be eligible for these treatments. Generally, candidates may include:

  • Adult patients (18 years or older) undergoing high-risk cardiac surgery[1]
  • Patients with predicted severe acute pancreatitis[2]

However, certain factors may exclude a patient from receiving this treatment, such as:

  • Known allergies to fish oil, fish products, or egg protein
  • Severe liver or kidney dysfunction
  • Pregnancy or breastfeeding
  • Recent history of certain medical conditions (e.g., heart attack, stroke)
  • Participation in other clinical trials

Possible Side Effects and Precautions

As with any medical treatment, there may be potential side effects or risks associated with highly refined fish oil. These may include:

  • Allergic reactions, especially in people with known allergies to fish or egg products
  • Increased risk of bleeding in patients with coagulation disorders
  • Potential interactions with other medications

It’s important to discuss any concerns or potential risks with your healthcare provider before considering this treatment.

Ongoing Research

The use of highly refined fish oil in critical care and surgical settings is an active area of research. Clinical trials are ongoing to better understand its effectiveness, optimal dosing, and potential benefits for various patient groups[1][2]. As more data becomes available, our understanding of this treatment’s role in patient care will continue to evolve.

Aspect Cardiac Surgery Trial Acute Pancreatitis Trial
Primary Objective Prevent atrial fibrillation and enhance recovery Reduce new organ failure and mortality
Patient Population High-risk cardiac surgery patients Predicted severe acute pancreatitis patients
Administration Intravenous, up to 200,000 μg/Kg daily for 8 days Intravenous, 2ml/kg/day for up to 7 days
Key Inclusion Criteria Adults ≥18 years, high-risk cardiac surgery Adults ≥18 years, first episode of predicted severe AP
Primary Endpoint Atrial fibrillation until 7 days after surgery Composite of new organ failure and/or mortality
Secondary Endpoints Time to discharge, organ dysfunction, ICU stay Mortality, infectious complications, hospital/ICU stay

FAQ

  • What is Highly Refined Fish Oil? Highly Refined Fish Oil is a purified form of fish oil that contains omega-3 fatty acids. It's being studied as a potential treatment in various medical conditions due to its anti-inflammatory properties.
  • How is Highly Refined Fish Oil administered in these trials? In both trials, Highly Refined Fish Oil is administered intravenously as an emulsion for infusion. The dosage and duration vary depending on the specific trial and condition being treated.
  • What are the main objectives of these clinical trials? The cardiac surgery trial aims to prevent atrial fibrillation and enhance recovery after surgery. The acute pancreatitis trial seeks to reduce new organ failure and mortality in patients with predicted severe acute pancreatitis.
  • Who can participate in these trials? Eligibility varies, but generally includes adult patients undergoing specific cardiac surgeries or diagnosed with predicted severe acute pancreatitis. There are specific inclusion and exclusion criteria for each trial.
  • What are the potential benefits of using Highly Refined Fish Oil in these conditions? Potential benefits include reduced inflammation, improved recovery after surgery, decreased risk of complications such as atrial fibrillation in cardiac patients, and reduced organ failure and mortality in severe acute pancreatitis patients.

Ongoing Clinical Trials on Highly Refined Fish Oil

  • Study on Omega-3 Fatty Acids for Reducing Organ Failure and Mortality in Patients with Severe Acute Pancreatitis

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark The Netherlands

  • Study on Fish Oil Emulsion for Preventing Atrial Fibrillation in High-Risk Cardiac Surgery Patients

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Atrial Fibrillation (AF): An irregular and often rapid heart rate that can increase the risk of stroke and other heart-related complications.
  • Cardiopulmonary Bypass (CPB): A technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and oxygen to the body.
  • EuroSCORE II: A risk model that predicts the risk of death after cardiac surgery based on patient characteristics and type of surgery.
  • Acute Pancreatitis (AP): A sudden inflammation of the pancreas that can cause severe abdominal pain and other complications.
  • APACHE-II Score: A severity-of-disease classification system used in intensive care units to predict patient outcomes.
  • C-Reactive Protein (CRP): A protein produced by the liver in response to inflammation, used as a marker of inflammation in the body.
  • Organ Failure: A condition where an organ is unable to perform its normal functions, which can be life-threatening if not treated promptly.
  • Immunomodulation: The adjustment of the immune response to a desired level, often to treat various diseases.
  • Systemic Inflammatory Response Syndrome (SIRS): A widespread inflammatory response that can be triggered by various conditions, including infections and pancreatitis.

References

  1. http://clinicaltrials.eu/trial/study-on-fish-oil-emulsion-for-preventing-atrial-fibrillation-in-high-risk-cardiac-surgery-patients/
  2. http://clinicaltrials.eu/trial/study-on-omega-3-fatty-acids-for-reducing-organ-failure-and-mortality-in-patients-with-severe-acute-pancreatitis/