Comparison of Three-chamber-bag Versus Compounded Bag

Study Overview
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Brief Summary
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The purpose of the study is to investigate the efficacy and safety of a convenient 3-chamber-bag containing aminoacids, glucose and lipid emulsion (LCT/MCT 20%) compared to a conventionally compounded monobag for parenteral nutrition.

Official Title
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A Prospective, Controlled, Randomized, Blinded, Parallel Group Multicentre Study on the Safety and Efficacy of a Convenience Three-chamber Bag for Parenteral Nutrition in Post-operative Patients After Abdominal Surgery Versus a Compounded Monobag

Conditions
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Parenteral Nutrition for Patients With Proven Insufficient Enteral Resorption

Intervention / Treatment
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* Drug: NuTRIflex Lipid peri
* Drug: compounded monobag


Participation Criteria
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Eligibility Criteria
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Inclusion: •Patients considered for elective open abdominal surgery Male and female patients ≥18 and <85 years of age Indication for total parenteral nutrition therapy: for 6 consecutive days NRS ≥3 Ability and willingness to give voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Review Board (IRB) prior to all evaluations, and to comply with the requirements of the study Exclusion: Major criteria: Body weight < 50 kg or > 70 kg Laparoscopic surgery Seriously ill patients in need of high energy nutrition support (i. e. > 2100 Kcal/day) Hepatic surgery Surgery with estimated blood loss >1000ml Participation in a clinical study with an investigational drug or an investigational medical device within one month prior to the start of study Receiving regular parenteral nutrition within 7 days before the onset of study General contraindications for parenteral nutrition (acidosis of various geneses, untreated disorders of electrolyte and fluid balance, hyperhydration, acute pulmonary edema, inadequate cellular oxygen supply) General contraindications for infusion therapy such as acute pulmonary oedema, hyperhydration and decompensated cardiac insufficiency, acute stroke Known hypersensitivity to egg-, soy-, and peanut proteins or any of the ingredients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>three chamber bag for parenteral nutrition containing lipids, glucose, amino acids and electrolytes | Drug: NuTRIflex Lipid peri<br>* parenteral nutrition<br>|
| Active Comparator: 2<br>compounded monobag including lipids, glucose, amino acids and electrolytes | Drug: compounded monobag<br>* parenteral nutrition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Course of prealbumin (from day 1 to day 7) |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical outcome parameters, haematology, liver function, blood biochemistry and electrolytes, coagulation function |  | 7 days |