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Comparing With Traditional Nitrogen Calorie Parenteral Nutrition Support, the Impact of Low Calorie and Low Nitrogen Intake on the Clinical Outcome of Gastrointestinal Postoperative Patients, Multicentre Post-Marketing Clinical Study

Phase 4
18 Years
80 Years
Not Enrolling
Gastrointestinal Neoplasms, Postoperative Complications

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Trial Information

Comparing With Traditional Nitrogen Calorie Parenteral Nutrition Support, the Impact of Low Calorie and Low Nitrogen Intake on the Clinical Outcome of Gastrointestinal Postoperative Patients, Multicentre Post-Marketing Clinical Study

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.

Inclusion Criteria:

- Patients undergone resection of stomach, intestine, or rectum, having the indication
of nutrition

- Nutrition risk screening scores around 3

- The age of the patients must be between 18 to 80

- The patients sign the confirmed consent letter

- Weight falls in the range of either 45-56 kg or 60-75 kg

Exclusion Criteria:

- Pregnant or breast feeding

- Contraindication of fluid infusion, acute pulmonary edema, brain edema and functional
insufficiency of the heart

- Hypersensitive to the ingredient of the trial product nutrient

- Chemotherapy within 7 days before the beginning of this trial

- Unstable angina pectoris

- Diabetes mellitus

- Disorder of lipid metabolism: triglycerides, cholesterol increased by 1.5 times above
the reference value

- Abnormal renal function: serum creatinine or BUN 1.5 times above normal reference

- Abnormal liver function: ALT or serum total bilirubin 1.5 times above normal
reference value

- Having severe drug allergy history and/or asthma

- On operation day, blood loss above 800 ml

- Contraindication to parenteral nutrition

- Receiving regular parenteral nutrition within 7 days before the trial

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Infectious complications

Outcome Time Frame:

POD+1 to POD+14

Safety Issue:


Principal Investigator

Wen-hua Zhan, MD,FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

First Affiliated Hospital, Sun Yat-Sen University


China: Ministry of Health

Study ID:

Hypocaloric PN



Start Date:

April 2005

Completion Date:

May 2006

Related Keywords:

  • Gastrointestinal Neoplasms
  • Postoperative Complications
  • parenteral nutrition
  • low calorie
  • low nitrogen
  • gastrointestinal neoplasms
  • gastrointestinal diseases
  • gastrectomy
  • colectomy
  • rectectomy
  • operations
  • Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Postoperative Complications