#1 Clinical Trials Search in Europe

Purified Egg Phospholipids

Recent clinical trials are investigating the potential benefits of using Purified Egg Phospholipids, a component of fish oil-based lipid emulsions, in two distinct medical scenarios. One study focuses on preventing atrial fibrillation in high-risk cardiac surgery patients, while another examines its effects on reducing organ failure and mortality in severe acute pancreatitis. These trials aim to explore how this compound may improve patient outcomes in critical care settings.

Table of Contents

What are Purified Egg Phospholipids?

Purified egg phospholipids are a component of a medical treatment known as fish oil-based lipid emulsion. This substance is derived from eggs and is used in combination with other ingredients, such as glycerol and highly refined fish oil, to create an intravenous (IV) solution[1]. The resulting product is an emulsion for infusion, which means it’s a liquid medication that can be administered directly into a patient’s bloodstream.

Medical Conditions and Treatments

Purified egg phospholipids, as part of fish oil-based lipid emulsions, are being studied for their potential benefits in treating various medical conditions, including:

  • Critical illness: Patients in intensive care units (ICUs) who are critically ill[1].
  • Cardiac surgery: High-risk patients undergoing cardiac surgery[1].
  • Severe acute pancreatitis: A serious inflammation of the pancreas[2].

Benefits and Potential Uses

Research suggests that purified egg phospholipids, when used as part of fish oil-based lipid emulsions, may offer several potential benefits:

  1. Prevention of atrial fibrillation: One study aims to demonstrate that fish oil emulsion is superior to placebo in preventing atrial fibrillation (an irregular and often rapid heart rate) in patients after cardiac surgery[1].
  2. Enhanced recovery: The treatment may help patients recover more quickly after cardiac surgery[1].
  3. Reduction of organ failure and mortality: In patients with severe acute pancreatitis, early administration of fish oil emulsion might reduce the risk of new organ failure and death[2].
  4. Anti-inflammatory effects: The omega-3 fatty acids in the fish oil component may help reduce inflammation, which is a key factor in many critical illnesses[2].

Ongoing Clinical Trials

Two significant clinical trials are currently investigating the use of purified egg phospholipids as part of fish oil-based lipid emulsions:

  1. Cardiac Surgery Trial: This phase II multicenter trial is studying the use of intravenous fish oil-based lipid emulsion in high-risk cardiac surgery patients. The primary goal is to prevent atrial fibrillation for up to 7 days after surgery[1].
  2. PLANCTON Trial: This study focuses on patients with predicted severe acute pancreatitis. It aims to determine if early intravenous administration of omega-3 fatty acids can reduce new organ failure and/or mortality[2].

Eligibility Criteria

The eligibility criteria for these trials vary, but generally include:

  • Adult patients (18 years or older)
  • Specific medical conditions (e.g., high-risk cardiac surgery patients, predicted severe acute pancreatitis)
  • No known allergies to fish oil, egg products, or related substances
  • No severe liver or kidney dysfunction
  • No recent participation in other clinical trials

It’s important to note that these criteria are specific to the clinical trials and may not reflect the eventual usage guidelines if the treatment is approved for general use[1][2].

Side Effects and Precautions

While purified egg phospholipids and fish oil-based emulsions are being studied for their potential benefits, it’s important to be aware of possible side effects and precautions:

  • Allergic reactions: Patients with known hypersensitivity to fish products, egg protein, or soya products should not use these treatments[1].
  • Bleeding risk: Patients with severe coagulation disorders may need to avoid this treatment[1].
  • Liver function: Those with severe liver dysfunction may not be suitable candidates for this treatment[1].
  • Kidney function: Patients with severe chronic kidney dysfunction may need to avoid this treatment[1].

As with any medical treatment, it’s crucial to consult with a healthcare professional before considering the use of purified egg phospholipids or fish oil-based emulsions. They can provide personalized advice based on your specific medical condition and health status.

Aspect Cardiac Surgery Trial Acute Pancreatitis Trial
Primary Objective Prevent atrial fibrillation after cardiac surgery Reduce new organ failure and/or mortality
Patient Population High-risk cardiac surgery patients Predicted severe acute pancreatitis patients
Drug Administration Max 200,000 μg/kg daily, up to 8 days 2 ml/kg/day for up to 7 days
Key Inclusion Criteria Adults ≥18 years, elective cardiac surgery with CPB First episode of AP, within 24 hours of diagnosis
Key Exclusion Criteria History of atrial fibrillation, severe liver dysfunction Organ failure on admission, recurrent pancreatitis
Primary Endpoint Atrial fibrillation within 7 days post-surgery Composite of new organ failure and mortality
Key Secondary Endpoints ICU/hospital stay, organ dysfunction, quality of life Mortality, infectious complications, hospital/ICU stay

FAQ

  • What is the main purpose of using Purified Egg Phospholipids in these clinical trials? Purified Egg Phospholipids are being studied as part of fish oil-based lipid emulsions to potentially prevent atrial fibrillation in cardiac surgery patients and reduce organ failure and mortality in severe acute pancreatitis patients.
  • How is the drug administered in these trials? The drug is administered intravenously as an emulsion for infusion. In the cardiac surgery trial, it's given at a maximum daily dose of 200,000 μg/kg, while in the pancreatitis trial, it's administered at 2 ml/kg/day for up to 7 days.
  • Who are the target patients for these clinical trials? The cardiac surgery trial targets high-risk adult patients undergoing elective cardiac surgery with cardiopulmonary bypass. The pancreatitis trial focuses on patients with predicted severe acute pancreatitis, diagnosed within 24 hours and with symptoms for less than 72 hours.
  • What are the main outcomes being measured in these trials? The cardiac surgery trial primarily measures atrial fibrillation occurrence within 7 days after surgery. The pancreatitis trial's primary endpoint is a composite of new organ failure and mortality. Both trials also assess various secondary outcomes related to patient recovery and complications.
  • Are there any specific exclusion criteria for these trials? Yes, both trials have specific exclusion criteria. Common exclusions include known hypersensitivity to fish oil or egg products, pregnancy or lactation, and severe liver dysfunction. The cardiac surgery trial also excludes patients with a history of atrial fibrillation, while the pancreatitis trial excludes those with organ failure on admission or recurrent pancreatitis.

Ongoing Clinical Trials on Purified Egg Phospholipids

  • 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 rhythm that can lead to blood clots in the heart. It's a common complication after cardiac surgery.
  • Cardiopulmonary Bypass (CPB): A technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.
  • Acute Pancreatitis (AP): A sudden inflammation of the pancreas that can cause severe abdominal pain and, in some cases, lead to serious complications.
  • Systemic Inflammatory Response Syndrome (SIRS): A widespread inflammatory response that can be triggered by various conditions, including infections and pancreatitis.
  • Omega-3 Fatty Acids: A type of essential fat found in fish oil, known for its potential anti-inflammatory properties.
  • Emulsion for Infusion: A liquid medication preparation where tiny droplets of one liquid are dispersed throughout another liquid, designed for intravenous administration.
  • EuroSCORE II: A risk model that predicts the risk of death after cardiac surgery based on patient characteristics and type of surgery.
  • APACHE-II Score: A severity-of-disease classification system used in intensive care units to predict patient outcomes.
  • C-Reactive Protein (CRP): A blood test marker for inflammation in the body, often used to assess the severity of conditions like pancreatitis.
  • Modified Marshall Score: A scoring system used to assess organ dysfunction or failure in critically ill patients.

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/