Efficacy and Safety of SmofKabiven Peripheral Versus Compounded Emulsion
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed 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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SmofKabiven Peripheral Continuous intravenous Infusion for SmofKabiven Peripheral via peripheral or central venous access for 14-24 hours/day. Target dose 34.3 ml per kg body weight/day. Duration of treatment 5 consecutive days. |
Drug: SmofKabiven Peripheral
Total Parenteral Nutrition
Other Names:
|
| Active Comparator: Hospital compounded emulsion Continuous intravenous Infusion for Hospital compounded emulsion via peripheral or central venous access for 14-24 hours/day. Target dose 34.3 ml per kg body weight/day. Duration of treatment 5 consecutive days. |
Drug: Hospital compounded emulsion
Total Parenteral Nutrition
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Serum Prealbumin [6 days]
Change in Serum Prealbumin
Secondary Outcome Measures
- C-reactive Protein (CRP) [6 days]
Change in CRP
- Linoleic acid [6 days]
Change in linoleic acid
- Linolenic acid [6 days]
Change in linolenic acid
- Arachidonic acid [6 days]
Change in arachidonic acid
- Eicosapentaenoic acid (EPA) [6 days]
Change in EPA
- Docosahexaenoic acis (DHA) [6 days]
Change in DHA
- Thromboxane B3 (TXB3) [6 days]
Change in TXB3
- Thromboxane B2 (TXB2) [6 days]
Change in TXB2
- Interleukin (IL)-1 [6 days]
Change in IL-1
- IL-2 [6 days]
Change in IL-2
- IL-6 [6 days]
Change in IL-6
- Cluster of Differentiation 4 (CD4) /Cluster of Differentiation 8 (CD8) [6 days]
Change in CD4/CD8
- Plasma amino acid (taurine) [6 days]
Change in plasma amino acid (taurine)
Other Outcome Measures
- Adverse Events (AE) [up to 16 days]
Coded according to Medical Dictionary for Regulatory Affairs (MedDRA) by System Organ Class (SOC) and preferred term
- Local intolerance for peripherally infusion [6 days]
Reported as AE
- Development of phlebitis [6 days]
Reported as AE
- Development of thrombophlebitis [6 days]
Reported as AE
- Blood pressure [up to 16 days]
Vital signs
- Heart rate [up to 16 days]
Vital signs
- Respiratory rate [up to 16 days]
Vital signs
- Body temperature [up to 16 days]
Vital signs
- Physical examination [up to 16 days]
Examination of abnormal findings in any system/organ
- Red blood cell (RBC) count [up to 16 days]
Laboratory variables
- Total white blood cell (WBC) count [up to 16 days]
Laboratory variables
- Haemoglobin (Hb) [up to 16 days]
Laboratory variables
- Haematocrit (Hct) [up to 16 days]
Laboratory variables
- Platelets [up to 16 days]
Laboratory variables
- Creatinine [up to 16 days]
Laboratory variables
- Urea [up to 16 days]
Laboratory variables
- Sodium [up to 16 days]
Laboratory variables
- Potassium [up to 16 days]
Laboratory variables
- Magnesium [up to 16 days]
Laboratory variables
- Total calcium [up to 16 days]
Laboratory variables
- Chloride [up to 16 days]
Laboratory variables
- Phosphate [up to 16 days]
Laboratory variables
- Aspartate aminotransferase (AST) [up to 16 days]
Laboratory variables
- Alanine aminotransferase (ALT) [up to 16 days]
Laboratory variables
- Alkaline phosphatase (AP) [up to 16 days]
Laboratory variables
- Gamma-glutamyl transpeptidase (γ-GT) [up to 16 days]
Laboratory variables
- Lactate dehydrogenase (LDH) [up to 16 days]
Laboratory variables
- Total and direct bilirubin [up to 16 days]
Laboratory variables
- Albumin [up to 16 days]
Laboratory variables
- Total protein [up to 16 days]
Laboratory variables
- Glucose [up to 16 days]
Laboratory variables
- Cholesterol [up to 16 days]
Laboratory variables
- Triglycerides [up to 16 days]
Laboratory variables
- Low Density Lipoprotein (LDL)-C [up to 16 days]
Laboratory variables
- High Density Lipoprotein (HDL)-C [up to 16 days]
Laboratory variables
- Fibrinogen [up to 16 days]
Laboratory variables
- Activated partial thromboplastin time (APTT) [up to 16 days]
Laboratory variables
- Prothrombin time (PT) [up to 16 days]
Laboratory variables
- International Normalised Ratio (INR) [up to 16 days]
Laboratory variables
- power of hydrogen (pH) value [up to 16 days]
Urine analysis
- Bilirubin [up to 16 days]
Urine analysis
- Protein [up to 16 days]
Urine analysis
- WBC [up to 16 days]
Urine analysis
- RBC [up to 16 days]
Urine analysis
- Urine Glucose [up to 16 days]
Urine analysis
- Ketone body [up to 16 days]
Urine analysis
- ECG [up to 16 days]
Electrocardiogram to assess cardiac disorders (e.g. Myocardial infarction, Pericarditis, QT interval Prolongation, etc.)
- Preparation time [5 days]
Comparison of the time required for TPN preparation for the two groups
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient is scheduled to undergo elective abdominal surgery
-
Female or male patient, age between 18 and 75 years (inclusively)
-
Postoperatively, patient is expected to receive 100% of the total daily energy demand via PN for at least 5 consecutive days
-
Body Mass Index (BMI) ≥ 16 and ≤ 30 kg /m2, and actual body weight ≥ 40 kg
-
Patient is capable to give Informed Consent, agrees to participate in the study, and signs the Informed Consent Form
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):
-
Intra-operative blood loss > 1000ml;
-
Development of a condition in which PN is contraindicated;
-
Intra- or postoperative urine output <0.5 ml/kg/h;
-
Need for postoperative haemo-filtration or dialysis;
-
Contraindication or inability to obtain peripheral or central venous catheter access;
-
Intra-operative decision on limited treatment, e.g. due to diagnosis of carcinomatosis;
-
Intra-operative severe complications including resuscitation, hemorrhagic and septic shock, acute single and multiple organ dysfunction including pulmonary, hepatic, and renal dysfunction prohibiting early postsurgical extubation, requiring liver-specific treatment and renal replacement therapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Friendship Hospital Capital Medical University | Beijing | China | ||
| 2 | Peking University People's Hospital | Beijing | China | ||
| 3 | The First Affiliated Hospital with Nanjing Medical University | Nanjing | China | ||
| 4 | The Affiliated Hospital of Qingdao University | Qingdao | China | ||
| 5 | Zhongshan Hospital, Fudan University | Shanghai | China |
Sponsors and Collaborators
- Fresenius Kabi
- Parexel
Investigators
- Principal Investigator: Wu Guohao, MD, Fudan University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
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- Bernstein LH. The systemic inflammatory response syndrome C-reactive protein and transthyretin conundrum. Clin Chem Lab Med. 2007;45(11):1566-7; author reply 1568-9.
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- Sergi G, Coin A, Enzi G, Volpato S, Inelmen EM, Buttarello M, Peloso M, Mulone S, Marin S, Bonometto P. Role of visceral proteins in detecting malnutrition in the elderly. Eur J Clin Nutr. 2006 Feb;60(2):203-9.
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- Singer P, Berger MM, Van den Berghe G, Biolo G, Calder P, Forbes A, Griffiths R, Kreyman G, Leverve X, Pichard C, ESPEN. ESPEN Guidelines on Parenteral Nutrition: intensive care. Clin Nutr. 2009 Aug;28(4):387-400. doi: 10.1016/j.clnu.2009.04.024. Epub 2009 Jun 7.
- SSPC. Intralipid 20%, Summary of Product Characteristics, dated 14 February 2007
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- SMKV-011-CP3