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Soya-Bean Oil Refined

This article examines clinical trials investigating the use of Soya-Bean Oil Refined as a component in parenteral nutrition formulations. These studies focus on patients undergoing major abdominal surgeries, exploring the timing and route of nutritional support to optimize recovery and minimize complications.

Table of Contents

What is SOYA-BEAN OIL REFINED?

SOYA-BEAN OIL REFINED is a key ingredient in parenteral nutrition formulations, such as SmofKabiven and SmofKabiven Perifer. It is a purified form of soybean oil that serves as a source of essential fatty acids and energy for patients who cannot receive nutrition through regular eating or tube feeding[1][2].

Medical Uses

SOYA-BEAN OIL REFINED is primarily used in parenteral nutrition for patients who:

  • Have undergone major abdominal surgery, such as oesophagectomy (surgical removal of part or all of the esophagus)
  • Cannot take food orally or through enteral feeding (tube feeding)
  • Require nutritional support to prevent muscle wasting and promote recovery

Composition and Formulation

SOYA-BEAN OIL REFINED is part of a complex mixture in parenteral nutrition products. In formulations like SmofKabiven, it is combined with:

  • Other oils: Olive oil, fish oil (rich in omega-3 fatty acids), and medium-chain triglycerides
  • Amino acids: Essential building blocks for proteins
  • Glucose: A source of energy
  • Electrolytes: Such as sodium, potassium, and calcium
  • Vitamins and minerals: Including zinc and magnesium
This combination provides a balanced nutritional support for patients unable to eat normally[1][2].

Administration and Dosage

Parenteral nutrition containing SOYA-BEAN OIL REFINED is typically administered through intravenous infusion. The dosage and duration of treatment depend on the patient’s individual needs and medical condition. In clinical trials, the maximum daily dose of SmofKabiven was reported to be up to 2463 ml, with treatment periods lasting up to 10 days[1][2].

Clinical Trials and Research

Recent clinical trials have investigated the use of parenteral nutrition containing SOYA-BEAN OIL REFINED in various medical scenarios:

  1. A study called the “EATERS trial” is comparing early versus delayed supplementary parenteral nutrition after major emergency abdominal surgery. This trial aims to determine if early nutritional support can reduce the risk of postoperative infections and other complications[1].
  2. Another trial is examining how the route of nutrition (parenteral vs. enteral) affects muscle wasting in patients recovering from oesophagectomy. This study seeks to understand the impact of different nutritional approaches on cachexia (a condition characterized by severe weight loss and muscle wasting) and postoperative complications[2].

Potential Benefits

The use of parenteral nutrition containing SOYA-BEAN OIL REFINED may offer several potential benefits:

  • Providing essential nutrients when normal eating is not possible
  • Supporting recovery after major surgery
  • Potentially reducing the risk of postoperative infections
  • Helping to prevent or minimize muscle wasting in critically ill patients
  • Improving overall nutritional status and energy balance

Considerations and Precautions

While parenteral nutrition with SOYA-BEAN OIL REFINED can be beneficial, it’s important to note:

  • It is typically used only when enteral nutrition (eating or tube feeding) is not possible or sufficient
  • The treatment should be monitored by healthcare professionals to ensure proper dosing and to watch for any potential side effects
  • Patients with certain conditions, such as severe liver disease or disorders of fat metabolism, may require special consideration before receiving this treatment
  • Pregnant or breastfeeding women may not be eligible for certain clinical trials involving this treatment

As with any medical treatment, the use of parenteral nutrition containing SOYA-BEAN OIL REFINED should be discussed with a healthcare provider to determine if it’s appropriate for an individual patient’s needs and medical condition[1][2].

Aspect Details
Study Drug Soya-Bean Oil Refined (component of SmofKabiven)
Patient Population Adults undergoing major abdominal surgeries
Main Objectives Compare timing and routes of nutritional support post-surgery
Primary Endpoints Infection rates, muscle size changes, complication rates
Secondary Endpoints Mortality rates, readmission rates, energy and protein intake
Key Inclusion Criteria Age ≥18, scheduled for specific abdominal surgeries
Key Exclusion Criteria Pregnancy, certain pre-existing conditions, immediate post-op ICU need
Treatment Duration Varies by trial, up to 10 days post-surgery

FAQ

  • What is Soya-Bean Oil Refined used for in these clinical trials? Soya-Bean Oil Refined is used as a component in parenteral nutrition formulations like SmofKabiven. These formulations provide essential nutrients to patients who cannot eat normally, particularly after major surgeries.
  • Who are the target patients for these clinical trials? The trials target adult patients undergoing major abdominal surgeries, such as emergency abdominal surgery or oesophagectomy (surgical removal of part of the esophagus).
  • What are the main objectives of these clinical trials? The trials aim to determine the best timing and route for providing nutritional support after surgery. They compare early versus delayed parenteral nutrition and examine how different nutrition methods affect post-surgical complications and muscle loss.
  • How is the effectiveness of the treatment measured? The trials measure various outcomes, including the rate of post-operative infections, complications during hospital stay, mortality rates, and changes in muscle size as assessed by CT scans.
  • Are there any specific exclusion criteria for these trials? Yes, exclusion criteria include pregnant or breastfeeding women, patients with certain pre-existing conditions, and those requiring intensive care immediately after surgery. Specific criteria vary between trials.

Ongoing Clinical Trials on Soya-Bean Oil Refined

  • Study on Nutrition Methods and Muscle Loss After Esophagectomy Using SmofKabiven and Drug Combination for Patients Recovering from Esophageal Surgery

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Early vs. Delayed Supplementary Parenteral Nutrition with SmofKabiven for Patients After Major Emergency Abdominal Surgery

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Parenteral Nutrition: A method of feeding that bypasses the gastrointestinal tract and provides nutrients directly into the bloodstream through a vein.
  • SmofKabiven: A brand of parenteral nutrition that contains a mixture of fats, amino acids, and other nutrients, including Soya-Bean Oil Refined.
  • Oesophagectomy: A surgical procedure to remove part or all of the esophagus, often performed to treat esophageal cancer.
  • Cachexia: A complex metabolic condition associated with underlying illness and characterized by loss of muscle mass and weight.
  • CT scan: Computed Tomography scan, an imaging technique that uses X-rays and a computer to create detailed images of the body's internal structures.
  • Laparotomy: A surgical incision into the abdominal cavity, typically to examine the abdominal organs.
  • Enteral nutrition: A method of providing nutrition directly into the digestive system, usually through a tube.
  • NRS-2002 score: Nutritional Risk Screening 2002, a tool used to identify patients at nutritional risk.

References

  1. http://clinicaltrials.eu/trial/study-on-early-vs-delayed-supplementary-parenteral-nutrition-with-smofkabiven-for-patients-after-major-emergency-abdominal-surgery/
  2. http://clinicaltrials.eu/trial/study-on-nutrition-methods-and-muscle-loss-after-esophagectomy-using-smofkabiven-and-drug-combination-for-patients-recovering-from-esophageal-surgery/