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.
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
- Conditions the study is for
- Gastrointestinal Neoplasms, Postoperative Complications
- 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
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.
Infectious complications
Measured: POD+1 to POD+14
Secondary outcomes (3)
Systemic inflammatory response syndrome
Measured: POD+1 to POD + 7
The length of hospital stay after operation
Measured: POD+1 to discharge
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.
- First posted1 Nov 2005 (estimated)
- Study startApr 2005
- Primary completionApr 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sino-Swed Pharmaceutical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou S Y S Medical School hospital, Wuhan TongJi Hospital, Chinese PLA General Hospital, Jie-Ping Wu Medical Foundation
- Investigators
- Wen-hua Zhan, MD,FACS, Principal investigator, First Affiliated Hospital, Sun Yat-Sen UniversityZhu-Ming Jiang, MD, FACS, Study chair, Parenteral & Enteral Centre, Peking Union Medical College Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00247338
- Acronym / sponsor ID
- Hypocaloric PN
- Keywords
- parenteral nutrition, low calorie, low nitrogen, gastrointestinal neoplasms, gastrointestinal diseases, gastrectomy, colectomy, rectectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sino-Swed Pharmaceutical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Guangzhou S Y S Medical School hospital, Wuhan TongJi Hospital, Chinese PLA General Hospital, Jie-Ping Wu Medical Foundation
- Study start
- Apr 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 1 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low calorie, low nitrogen parenteral nutrition for patient with NRS score 3 | Drug | – |
Primary outcome
Infectious complications
Time frame: POD+1 to POD+14
3 secondary outcomes
Systemic inflammatory response syndrome
Time frame: POD+1 to POD + 7
The length of hospital stay after operation
Time frame: POD+1 to discharge
Post-operative nutritional cost & total treatment cost
Time frame: POD+1 to discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2008.
- Derived from this study: PubMed 17919374Zhan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-hua Zhan, MD,FACS principal investigator
First Affiliated Hospital, Sun Yat-Sen University
Zhu-Ming Jiang, MD, FACS study chair
Parenteral & Enteral Centre, Peking Union Medical College Hospital
3 sites in 1 country: see every site and its status.
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.