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Gastrointestinal NeoplasmsPhase 4NCT00247338

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

A Phase 4 study testing low calorie, low nitrogen parenteral nutrition for patient with NRS score 3 in people with Gastrointestinal Neoplasms and Postoperative Complications, run by Sino-Swed Pharmaceutical Corporation at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
low calorie, low nitrogen parenteral nutrition for patient with NRS score 3
How many people
120 participants
Where
3 sitesChina
Study dates
Apr 2005to May 2006
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

China3 sites
  • Department of General Surgery, General Hospital of PLA

    Beijing, 100853

  • Department of Gastrointestinal Surgery, The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • Department of General Surgery, Affiliated Hospital of Medical University of Tongji

    Wuhan, Hubei, 430030

Other trials in China

About this study

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

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.

Read the 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.

Being tested
low calorie, low nitrogen parenteral nutrition for patient with NRS score 3
Keywords
parenteral nutrition, low calorie, low nitrogen, gastrointestinal neoplasms, gastrointestinal diseases, gastrectomy, colectomy, rectectomy, operations
Medical subject headings
Gastrointestinal Neoplasms, Postoperative Complications, Hyperphagia, Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • low calorie, low nitrogen parenteral nutrition for patient with NRS score 3Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infectious complications

    Measured: POD+1 to POD+14

Secondary outcomes (3)
  1. Systemic inflammatory response syndrome

    Measured: POD+1 to POD + 7

  2. The length of hospital stay after operation

    Measured: POD+1 to discharge

  3. Post-operative nutritional cost & total treatment cost

    Measured: POD+1 to discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionApr 2006
  4. Study completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00247338
Sponsor's protocol ID
Hypocaloric PN
Status last verified
May 2008
First submitted
31 Oct 2005
Last updated
12 May 2008
Results posted
No

Publications

  • Zhan WH, Jiang ZM, Tang Y, Wu YP, Liu JW, Zhang YJ, Chen W, Liu T, Yao C. [Impact of hypocaloric and hypo-nitrogen parenteral nutrition on clinical outcome in postoperative patients: a multi-center randomized controlled trial of 120 cases]. Zhonghua Yi Xue Za Zhi. 2007 Jul 3;87(25):1729-33. Chinese.

    PubMed 17919374

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing low calorie, low nitrogen parenteral nutrition for patient with NRS score 3 in people with Gastrointestinal Neoplasms and Postoperative Complications, run by Sino-Swed Pharmaceutical Corporation at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infectious complications (time frame: POD+1 to POD+14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00247338, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2008.

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