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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CombiflexOmega | Experimental |
| |
| SmofKabiven | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CombiflexOmega | Drug | intravenously over 5 days infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of adverse drug reaction | 6days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of laboratory parameters (biochemistry, hematology, coagulation) | 7days | |
| Changes of vital signs | 7days |
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Inclusion Criteria:
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
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seoul | South Korea |
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| SmofKabiven |
| Drug |
intravenously over 5 days infusion |
|