NCT00247338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

May 12, 2008

Status Verified

May 1, 2008

Enrollment Period

1 year

First QC Date

October 31, 2005

Last Update Submit

May 9, 2008

Conditions

Gastrointestinal NeoplasmsPostoperative Complications

Keywords

parenteral nutritionlow calorielow nitrogengastrointestinal neoplasmsgastrointestinal diseasesgastrectomycolectomyrectectomyoperations

Outcome Measures

Primary Outcomes (1)

  • Infectious complications

    POD+1 to POD+14

Secondary Outcomes (3)

  • 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

Interventions

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Guangzhou, Guangdong, 510080, China

Location

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

Wuhan, Hubei, 430030, China

Location

Department of General Surgery, General Hospital of PLA

Beijing, 100853, China

Location

Related Publications (1)

  • 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.

    PMID: 17919374DERIVED

MeSH Terms

Conditions

Gastrointestinal NeoplasmsPostoperative ComplicationsHyperphagiaGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Study Officials

  • Wen-hua Zhan, MD,FACS

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

  • Zhu-Ming Jiang, MD, FACS

    Parenteral & Enteral Centre, Peking Union Medical College Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 31, 2005

First Posted

November 1, 2005

Study Start

April 1, 2005

Primary Completion

April 1, 2006

Study Completion

May 1, 2006

Last Updated

May 12, 2008

Record last verified: 2008-05

Locations

CN(3)