The Impact of Low Calorie and Low Nitrogen Parenteral Nutrition Support on the Clinical Outcome of Postoperative Patients

Sponsor

Sino-Swed Pharmaceutical Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00247338

Collaborator

Guangzhou S Y S Medical School hospital (Other), Wuhan TongJi Hospital (Other), Beijing 301 hospital (Other), Jie-Ping Wu Medical Foundation (Other)

120

Enrollment

Locations

Duration (Months)

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Neoplasms Postoperative Complications	Drug: low calorie, low nitrogen parenteral nutrition for patient with NRS score 3	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

May 1, 2006

Outcome Measures

Primary Outcome Measures

Infectious complications [POD+1 to POD+14]

Secondary Outcome Measures

Systemic inflammatory response syndrome [POD+1 to POD + 7]
The length of hospital stay after operation [POD+1 to discharge]
Post-operative nutritional cost & total treatment cost [POD+1 to discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 value
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastrointestinal Surgery, The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510080
2	Department of General Surgery, Affiliated Hospital of Medical University of Tongji	Wuhan	Hubei	China	430030
3	Department of General Surgery, General Hospital of PLA	Beijing		China	100853

Sponsors and Collaborators

Sino-Swed Pharmaceutical Corporation
Guangzhou S Y S Medical School hospital
Wuhan TongJi Hospital
Beijing 301 hospital
Jie-Ping Wu Medical Foundation

Investigators

Principal Investigator: Wen-hua Zhan, MD,FACS, First Affiliated Hospital, Sun Yat-Sen University
Study Chair: Zhu-Ming Jiang, MD, FACS, Parenteral & Enteral Centre, Peking Union Medical College Hospital