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

May 9, 2008 updated by: Sino-Swed Pharmaceutical Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100853
        • Department of General Surgery, General Hospital of PLA
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Department of Gastrointestinal Surgery, The First Affiliated Hospital, Sun Yat-sen University
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Department of General Surgery, Affiliated Hospital of Medical University of Tongji

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infectious complications
Time Frame: POD+1 to POD+14
POD+1 to POD+14

Secondary Outcome Measures

Outcome Measure
Time Frame
Systemic inflammatory response syndrome
Time Frame: POD+1 to POD + 7
POD+1 to POD + 7
The length of hospital stay after operation
Time Frame: POD+1 to discharge
POD+1 to discharge
Post-operative nutritional cost & total treatment cost
Time Frame: POD+1 to discharge
POD+1 to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sino-Swed Pharmaceutical Corporation

Collaborators

Wuhan TongJi Hospital
Guangzhou S Y S Medical School 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

October 31, 2005

First Submitted That Met QC Criteria

October 31, 2005

First Posted (Estimate)

November 1, 2005

Study Record Updates

Last Update Posted (Estimate)

May 12, 2008

Last Update Submitted That Met QC Criteria

May 9, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hypocaloric PN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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