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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients who have undergone major emergency abdominal surgery. The study is investigating the effects of two different approaches to providing additional nutrition through the veins, known as supplementary parenteral nutrition. The two treatments being compared are called SmofKabiven and SmofKabiven Perifer, which are both emulsions for infusion. These treatments contain a mix of essential nutrients, including amino acids, oils, and minerals, to support recovery after surgery.

The purpose of the study is to compare the impact of starting supplementary parenteral nutrition early versus postponing it on the risk of infections that patients might acquire in the hospital after their surgery. Participants in the study will receive either the early or postponed nutrition treatment, or a placebo, and their progress will be monitored over time. The study aims to see if the timing of the nutrition affects the rate of infections and other complications during the hospital stay.

Throughout the study, researchers will observe various outcomes, such as the rate of complications, the length of hospital stay, and mortality rates at 30, 90, and 180 days after surgery. They will also track the amount and type of energy and protein intake during the hospital stay. This information will help determine the best approach to providing nutrition to patients recovering from major emergency abdominal surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. This study aims to compare the effects of early versus postponed supplementary parenteral nutrition after major emergency abdominal surgery.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying that you are aged 18 or above, have undergone a primary emergency midline laparotomy, and meet other specific criteria.

  3. Step 3

    Randomization

    You will be randomly assigned to one of two groups: one receiving early supplementary parenteral nutrition and the other receiving postponed supplementary parenteral nutrition.

  4. Step 4

    Treatment administration

    If assigned to the early group, you will receive SmofKabiven Perifer or SmofKabiven as an emulsion for infusion shortly after surgery. If in the postponed group, the infusion will begin later. The infusion is administered through a vein.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, your health will be closely monitored. This includes tracking any infections, complications, and your overall recovery. The study will also record your energy and protein intake.

  6. Step 6

    Completion of study

    The study will conclude with a final assessment to evaluate outcomes such as the rate of infections and other complications, length of hospital stay, and overall recovery.

Who can join the trial?

5 criteria

  • Must be 18 years or older.
  • Must have had a primary emergency midline laparotomy (a type of major abdominal surgery).
  • Must have a preoperative NRS-2002 score of less than 7 (a score used to assess nutritional risk before surgery).
  • Must have no contraindications (no medical reasons preventing) for oral or enteral intake (eating or tube feeding) after surgery.
  • Must have an intake of less than 30% of the recommended caloric target on the second day after surgery.

Who cannot join the trial?

4 criteria

  • Patients who have not undergone major emergency abdominal surgery. This refers to urgent and significant surgery in the belly area.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a clinical trial group that is not included in this study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Supplementary Parenteral Nutrition is a type of nutrition given directly into the bloodstream through a vein. This method is used when a person cannot eat or absorb enough nutrients through their digestive system. In this trial, the focus is on providing this nutrition either early or later after major emergency abdominal surgery. The goal is to see if the timing of this nutrition affects the risk of infections that can occur after surgery. This therapy is important because it helps ensure that patients receive the necessary nutrients to support healing and recovery when they cannot eat normally.

What is already known about the treatment

Supplementary Parenteral Nutrition – This medication is administered intravenously, meaning it is delivered directly into the bloodstream through a vein. It is currently being studied in clinical trials to determine its effectiveness in reducing the risk of infections after major emergency abdominal surgery. The main therapeutic use of this nutrition is to provide essential nutrients to patients who cannot eat or absorb enough food through their digestive system. At the molecular level, it supplies the body with necessary proteins, carbohydrates, fats, vitamins, and minerals, bypassing the digestive tract. It is classified as a form of nutritional support therapy.

Investigated diseases

Major emergency abdominal surgery – This term refers to urgent surgical procedures performed on the abdominal area due to life-threatening conditions such as trauma, perforation, or severe infection. The progression of the condition requiring surgery can vary widely, often involving rapid onset of severe symptoms like intense abdominal pain, bleeding, or infection. The surgery itself aims to address the immediate threat, such as repairing damaged organs or removing obstructions. Post-surgery, patients may experience a range of complications, including infections, which can affect recovery. The healing process involves monitoring for any signs of complications and ensuring proper nutrition and care to support recovery. The condition's progression and recovery depend on the underlying cause and the patient's overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505378-14-00Estimated enrolment342 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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