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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR19006 | Experimental |
| |
| All-in-one parenteral nutrition | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR19006 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum prealbumin level on the 6th day after operation. | on day 6 postoperation |
| Measure | Description | Time Frame |
|---|---|---|
| The change of serum prealbumin level from baseline on the 6th day after operation. | on days 1 and 6 post operation | |
| The changes of linoleic acid level from baseline on the 6th day after operation. | on days 1 and 6 post operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hefei First People's Hospital | Hefei | Anhui | 230061 | China |
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| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Phase Ⅲ, multi-center, randomized, single-blind, parallel controlled with active drug, confirmatory clinical trial.
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| All-in-one parenteral nutrition | Drug | 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). |
|
| 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 changes of DHA 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 |