Status:
COMPLETED
The Impact of Low Calorie and Low Nitrogen Parenteral Nutrition Support on the Clinical Outcome of Postoperative Patients
Lead Sponsor:
Sino-Swed Pharmaceutical Corporation
Collaborating Sponsors:
Guangzhou S Y S Medical School hospital
Wuhan TongJi Hospital
Conditions:
Gastrointestinal Neoplasms
Postoperative Complications
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 traditio...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00247338
Start Date
April 1 2005
End Date
May 1 2006
Last Update
May 12 2008
Active Locations (3)
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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