Clinical trial · Interventional
The Impact of Low Calorie and Low Nitrogen Parenteral Nutrition Support on the Clinical Outcome of Postoperative Patients
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
NCT00247338CI-TRIAL-00001450completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| low calorie, low nitrogen parenteral nutrition for patient with NRS score 3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Infectious complications
- timeFrame
- POD+1 to POD+14
Secondary outcomes (3)
- measure
- Systemic inflammatory response syndrome
- timeFrame
- POD+1 to POD + 7
- measure
- The length of hospital stay after operation
- timeFrame
- POD+1 to discharge
- measure
- Post-operative nutritional cost & total treatment cost
- timeFrame
- POD+1 to discharge
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZhan 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 17919374