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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.
Full description
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).
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Inclusion criteria
Exclusion criteria
Patient has received PN or parenteral amino acids in the last 10 days before randomization (exception: administration of glucose will be allowed)
Severe liver insufficiency or AST, ALT or total bilirubin at least 1.5-times higher than the upper limit of normal range
International Normalised Ratio (INR) at least 1.5 times higher than the upper limit of normal range
Uncontrolled hyperglycaemia, fasting blood glucose > 180 mg/ dl (10 mmol/L)
Severe renal impairment defined as serum creatinine value at least 1.5 times higher than the upper limit of normal range
Serious hyperlipidaemia (serum cholesterol and/or triglycerides and/or LDL-C level at least 1.5 times higher than the upper limit of normal range)
Inborn abnormality of amino acid metabolism
Present signs of acute pancreatitis, hypothyroidism or hyper-thyroidism as diagnosed clinically
Serum level of any of the electrolytes (sodium, potassium, magnesium, total calcium, chloride, phosphate) above the upper limit of the normal range
Known unstable metabolism (e.g., known metabolic acidosis)
Known hypersensitivity to fish-, egg-, soybean, or peanut protein or to any of the active substances or excipients of the study drugs
General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency /congestive heart failure
Unstable conditions (e.g., acute myocardial infarction, stroke, embolism, severe sepsis, shock)
Drug abuse and/or chronic alcoholism
Psychiatric diseases, epilepsy
Administration of growth hormones within the previous 4 weeks before surgery, or chronic maintenance therapy with systemic glucocorticoids 4 weeks before surgery
Participation in a clinical study with an investigational drug or an investigational medical device within one month prior to start of study or during study
Patient is pregnant or lactating and intends to continue breast-feeding
Development of intraoperative/ postoperative conditions (assessed after surgery and before enrollment of patients):
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272 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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