A Safety, Efficacy Study of CombiflexOmega Versus SmofKabiven in Patients With Parenteral Nutrition

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and efficacy of CombiflexOmega in comparison to SmofKabiven in postoperative patients requiring parenteral nutrition.

Official Title
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A Randomized, Open, Multicenter, Compared Phase III Trial to Evaluate the Safety, Efficacy of CombiflexOmega and SmofKabiven in Postoperative Patients Requiring Parenteral Nutrition

Conditions
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Parent

Intervention / Treatment
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* Drug: CombiflexOmega
* Drug: SmofKabiven


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 20 and older Patients are expected to require PN for more than 5 days Patients who voluntarily signed the consent form Exclusion Criteria: Patients are expected difficult to survive more than 5 days Pregnant or breast-feeding women BMI > 30 kg/m2 Patients with severe blood coagulation disorders Patients with congenital amino acid metabolism disorders Patients with acute shock Patients with uncontrollable diabetes mellitus Patients with hemophage syndrome Patients with hypopotassemia (K < 3.0mEq/L) Patients having the history of myocardial infarction Patients reported the following laboratory value fasting TG > 250mg/dl, TC > 300mg/dl ALT/AST ≥ 2×ULN, Bilirubin ≥ 3mg/dl (Exception : patients with periampullary carcinoma including biliary tract or pancreas) Creatinine ≥ 1.5mg/dl Ca > 11.2mg/dl, Na ≥ 145mEq/L, Mg ≥ 2.1mEq/L, K ≥ 5.5mEq/L Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug Patients having the history of drug or alcohol abuse General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, cardiac decompensation Patients are in unstable conditions Patients with difficult peripheral intravenous Patients with parenteral nutrition within 7 days prior to start of the trial Participation in another clinical study with an investigational drug or an investigational medical device within 28 days prior to start of study Patients judged to be unsuitable for this trial by investigators

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CombiflexOmega<br> | Drug: CombiflexOmega<br>* intravenously over 5 days infusion<br>|
| Active Comparator: SmofKabiven<br> | Drug: SmofKabiven<br>* intravenously over 5 days infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of adverse drug reaction |  | 6days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of laboratory parameters (biochemistry, hematology, coagulation) |  | 7days | 
| Changes of vital signs |  | 7days |