The present protocol describes a randomized, open-labelled study in which either SmofKabiven Peripheral or a hospital compounded control Parenteral Nutrition (PN) regimen will be given to adult surgical patients for 5 consecutive days. As serum prealbumin is a well-established surrogate efficacy parameter reflecting the patient´s nutritional status, the absolute change of the serum prealbumin level at the day of the final study visit compared to baseline will represent the primary efficacy parameter in the present study.
In addition, other variables will be assessed in this study, i.e., C-reactive Protein (CRP), free fatty acids, immunology parameters, taurine, comparison of the time required for Total Parenteral Nutrition (TPN) preparation of the two groups, the results of physical examination, vital signs, relevant nutrition- and safety-related laboratory parameters in venous blood and urine, the results of an Electrocardiography (ECG), and the number, severity, seriousness, clinical relevance, relatedness and outcome of Adverse Events (AEs). The aim of the planned study is to demonstrate that SmofKabiven Peripheral is not inferior to the comparative drug (compounded emulsion).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
272
Total Parenteral Nutrition
Total Parenteral Nutrition
Beijing Friendship Hospital Capital Medical University
Beijing, China
Peking University People's Hospital
Beijing, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Serum Prealbumin
Change in Serum Prealbumin
Time frame: 6 days
C-reactive Protein (CRP)
Change in CRP
Time frame: 6 days
Linoleic acid
Change in linoleic acid
Time frame: 6 days
Linolenic acid
Change in linolenic acid
Time frame: 6 days
Arachidonic acid
Change in arachidonic acid
Time frame: 6 days
Eicosapentaenoic acid (EPA)
Change in EPA
Time frame: 6 days
Docosahexaenoic acis (DHA)
Change in DHA
Time frame: 6 days
Thromboxane B3 (TXB3)
Change in TXB3
Time frame: 6 days
Thromboxane B2 (TXB2)
Change in TXB2
Time frame: 6 days
Interleukin (IL)-1
Change in IL-1
Time frame: 6 days
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Zhongshan Hospital, Fudan University
Shanghai, China
IL-2
Change in IL-2
Time frame: 6 days
IL-6
Change in IL-6
Time frame: 6 days
Cluster of Differentiation 4 (CD4) /Cluster of Differentiation 8 (CD8)
Change in CD4/CD8
Time frame: 6 days
Plasma amino acid (taurine)
Change in plasma amino acid (taurine)
Time frame: 6 days