In short
There is currently 1 ongoing clinical trial investigating nutritional support for patients who have undergone major emergency abdominal surgery, which may include cases related to intestinal infarction. This trial is examining whether the timing of supplementary parenteral nutrition affects recovery outcomes and infection rates after surgery.
Clinical trial locations
Study on Early vs. Delayed Supplementary Parenteral Nutrition with SmofKabiven for Patients After Major Emergency Abdominal Surgery
This clinical trial is designed for patients who have undergone major emergency abdominal surgery and focuses on comparing two different approaches to providing nutritional support during recovery. The study investigates whether starting supplementary parenteral nutrition early or delaying it affects the risk of hospital-acquired infections and other complications.
Main inclusion criteria: To participate in this study, patients must be at least 18 years old and have undergone a primary emergency midline laparotomy, which is a major type of abdominal surgery performed through a vertical incision in the middle of the abdomen. Participants must have a preoperative nutritional risk score (NRS-2002) of less than 7, indicating they were not severely malnourished before surgery. They should have no medical reasons preventing them from eating or receiving tube feeding after surgery. Additionally, on the second day following surgery, their food intake must be less than 30% of their recommended caloric needs.
Main exclusion criteria: Patients who have not undergone major emergency abdominal surgery cannot participate. Those outside the specified age range or who belong to vulnerable populations requiring special protection are also excluded. Additionally, patients who are part of other clinical trial groups not included in this study are not eligible.
Focus and goals: The primary goal of this trial is to determine whether the timing of supplementary parenteral nutrition impacts the rate of hospital-acquired infections after major emergency abdominal surgery. Researchers will monitor various outcomes throughout the hospital stay, including the rate of complications, length of hospital stay, and mortality rates at 30, 90, and 180 days after surgery. The study also tracks the amount and type of energy and protein intake participants receive. This information will help identify the best approach to nutritional support for patients recovering from this type of surgery.
Investigational treatment: The trial uses supplementary parenteral nutrition, specifically the products SmofKabiven and SmofKabiven Perifer. These are emulsions for infusion delivered directly into the bloodstream through a vein. They contain a mix of essential nutrients, including amino acids, oils, and minerals, designed to support recovery when patients cannot eat or absorb enough food through their digestive system. Participants are randomly assigned to receive either early nutrition support (shortly after surgery) or delayed nutrition support (started later in the recovery process). This method bypasses the digestive tract and ensures that patients receive necessary proteins, carbohydrates, fats, vitamins, and minerals to support healing.
Summary
Currently, there is one active clinical trial for patients who may have experienced intestinal infarction as part of a major emergency abdominal surgery situation. This trial is being conducted in Denmark and focuses on optimizing nutritional support during the critical recovery period following emergency surgery. The study specifically investigates the therapeutic products SmofKabiven and SmofKabiven Perifer, examining whether early versus delayed administration of supplementary parenteral nutrition affects infection rates and overall recovery outcomes. This research is particularly important for patients who cannot meet their nutritional needs through normal eating in the days immediately following surgery, as proper nutrition is essential for wound healing and preventing complications.
