The Impact of Low Calorie and Low Nitrogen Parenteral Nutrition Support on the Clinical Outcome of Postoperative Patients
Condition: Gastrointestinal Neoplasms; Postoperative Complications
MeSH terms: Gastrointestinal Neoplasms; Digestive System Neoplasms; Postoperative Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is designed to investigate the influence of parenteral nutrition (PN) with low
      nitrogen and calorie supply on the clinical outcome of patients after an operation compared
      to that of traditional PNs.
    

Detailed description: 
      Wretlind from Sweden invented fat emulsion as early as 1961, which has been applied to
      parenteral nutrition. Dudrick and Wilmore from America introduced intravenous nutrition
      containing carbohydrates and amino acids, which was termed as high intravenous nutrition in
      1967. Afterwards, it was proven that this treatment cannot improve clinical outcome but
      increases complications, such as infection, etc. Because of the action of catecholamine and
      corticosteroids under stress after an operation, insulin resistance becomes a main indicator
      of endocrine problems for patients. Under such circumstances, even intake of glucose at
      physiological doses can result in hyperglycosemia and increase the incidence of complications
      of infection and metabolism. Overseas and domestic scholars studied parenteral nutrition (PN)
      with low nitrogen and calorie supply long ago, and the results revealed that PN with low
      nitrogen and calorie supply can significantly decrease oxygen consumption of patients under
      stress of an operation, alleviate the inflammation response, reduce the rate of cholestasis
      and cut the treatment cost during hospitalization. On the other hand, catabolism of protein
      significantly increases after operation and trauma, but it cannot be simply corrected by high
      dose amino acid intake. Contrarily, improperly increasing of the intake of amino acids
      aggravates metabolism further. A domestic study on PN with a low calorie supply has revealed
      benefits on the clinical outcome of patients after an operation, such as a domestic
      randomised controlled study that has proven that intravenous nutrition with a low nitrogen
      and calorie supply significantly lowered the level of blood glucose, cut nutrition related
      medicine costs, shortened the length of hospital stay and reduced the incidence of phlebitis
      after operation, and also has the tendency to reduce the incidence of complications after an
      operation. Meta analysis has revealed that PN with a low nitrogen and calorie supply can
      control blood glucose better and may reduce the incidence of infection related complications,
      and has the tendency of shortening the length of hospital stay.

      The development of all-in-one PN has experienced the process of sequential single bottle
      infusion, poly-bottle serial infusion, hospital prepared all-in-one solution and
      industrialized three compartment bags, and currently, the utilization of industrialized three
      compartment bags has been the dominant tendency of clinical parenteral nutrition among
      countries in Europe and Asia. Domestically Kabiven peripheral (FK, Germany, 1440 ml
      H20040008, 1920 ml H20040019) are the first three compartment bags, which is a pre-filling
      standard all-in-one nutrition solution. The two specifications (1440 ml,1920 ml) first
      launched to the market already satisfy most demands of PN support for patients, and provide
      PN with a low nitrogen and calorie supplying administration platform for patients after
      operation, spare time for the preparation of all-in-one nutrition solution, and avoid
      preparing such solutions under the common clean condition in hospitals.

      Up to now, there is no report of a randomized controlled study about the utilization of three
      compartment bags domestically.
    

Intervention name(s): low calorie, low nitrogen parenteral nutrition for patient with NRS score 3
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: parenteral nutrition; low calorie; low nitrogen; gastrointestinal neoplasms; gastrointestinal diseases; gastrectomy; colectomy; rectectomy; operations