Parenteral Nutrition
Conditions
Brief summary
This is a phase Ⅲ, multi-center, randomized, single-blind, parallel controlled with active drug, confirmatory study, and the purpose of the study is to evaluate the efficacy and safety of HR190006 for postoperative parenteral nutrition via central venous catheter.
Interventions
DRUGHR19006
An emulsion containing the full supply of carbohydrates, amino acids and lipids with a total energy content of 1265kcal in a 1250 ml volume, administered via a central venous line over a time period of approximately 15 hours per day.
DRUGAll-in-one parenteral nutrition
Trial participants are prescribed TPN by the attending physician, which will be administered via a central venous line over a time period of approximately 15 hours per day. The formulation is an emulsion containing the full supply of carbohydrates, amino acids and lipids with a total energy content of 1265kcal in a 1250 ml volume (nitrogen content, heat and liquid quantity as equal as HR19006).
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Phase Ⅲ, multi-center, randomized, single-blind, parallel controlled with active drug, confirmatory clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent; 2. Elective operation of Gastrointestinal; 3. Male or female，aged 18-80 years inclusive; 4. Body Weight at least 40kg, Body mass index (BMI) 18.5-30 kg/m2 inclusive; 5. Nutrition Risk Screening (NRS2002) score at least 3 points.
Exclusion criteria
1. Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients; 2. Congenital amino acid metabolism abnormality; 3. Hypothyroidism or hyperthyroidism; 4. Significant abnormal values of clinical laboratory examination; 5. Uncompensated hemodynamical failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure); 6. General contraindications for infusion therapy such as acute pulmonary oedema, hyper-hydration and decompensated cardiac insufficiency; 7. Subjects with a history of mental system diseases and cognitive dysfunction; 8. Serious complications during or after operation; 9. Previous (\< 2 weeks) received treatment with intravenous nutrition; 10. Previous (\< 4 weeks) or ongoing treatment with growth hormone or corticosteroids; 11. Pregnant or nursing women; 12. No birth control during the specified period of time; 13. Participated in clinical trials of other drugs (received experimental drugs); 14. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum prealbumin level on the 6th day after operation. | on day 6 postoperation |
Secondary
| Measure | Time frame |
|---|---|
| The changes of linoleic acid level from baseline on the 6th day after operation. | on days 1 and 6 post operation |
| The changes of arachidonic acid level from baseline on the 6th day after operation. | on days 1 and 6 post operation |
| The changes of linolenic acid level from baseline on the 6th day after operation. | on days 1 and 6 post operation |
| The changes of EPA level from baseline on the 6th day after operation. | on days 1 and 6 post operation |
| The change of serum prealbumin level from baseline on the 6th day after operation. | on days 1 and 6 post operation |
| The changes of CRP level from baseline on the 6th day after operation. | on days 1 and 6 post operation |
| The changes of IL-6 level from baseline on the 6th day after operation. | on days 1 and 6 post operation |
| The changes of TNF-α level from baseline on the 6th day after operation. | on days 1 and 6 post operation |
| The incidence of new postoperation infection. | on days 1 and 6 post operation |
| The changes of DHA level from baseline on the 6th day after operation. | on days 1 and 6 post operation |
Countries
China
Outcome results
None listed