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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
240
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.
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).
Hefei First People's Hospital
Hefei, Anhui, China
Serum prealbumin level on the 6th day after operation.
Time frame: on day 6 postoperation
The change of serum prealbumin level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The changes of linoleic acid level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The changes of arachidonic acid level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The changes of linolenic acid level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The changes of EPA level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The changes of DHA level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The changes of CRP level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The changes of IL-6 level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The changes of TNF-α level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The incidence of new postoperation infection.
Time frame: on days 1 and 6 post operation