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

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sino-Swed Pharmaceutical Corporation
• Collaborators: Beijing 301 hospital; Guangzhou S Y S Medical School hospital; Jie-Ping Wu Medical Foundation; Wuhan TongJi Hospital

Criteria

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