<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03792087</url>
  </required_header>
  <id_info>
    <org_study_id>SMKV-011-CP3</org_study_id>
    <nct_id>NCT03792087</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of SmofKabiven Peripheral Versus Compounded Emulsion</brief_title>
  <official_title>Efficacy &amp; Safety of SmofKabiven Peripheral vs Compounded Emulsion: A Randomized, Active-Controlled, Open-Labelled, Multi-Centre Study in Adult Surgical Patients Requiring Parenteral Nutrition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fresenius Kabi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parexel</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fresenius Kabi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present protocol describes a randomized, open-labelled study in which either SmofKabiven&#xD;
      Peripheral or a hospital compounded control Parenteral Nutrition (PN) regimen will be given&#xD;
      to adult surgical patients for 5 consecutive days.&#xD;
&#xD;
      As serum prealbumin is a well-established surrogate efficacy parameter reflecting the&#xD;
      patient´s nutritional status, the absolute change of the serum prealbumin level at the day of&#xD;
      the final study visit compared to baseline will represent the primary efficacy parameter in&#xD;
      the present study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In addition, other variables will be assessed in this study, i.e., C-reactive Protein (CRP),&#xD;
      free fatty acids, immunology parameters, taurine, comparison of the time required for Total&#xD;
      Parenteral Nutrition (TPN) preparation of the two groups, the results of physical&#xD;
      examination, vital signs, relevant nutrition- and safety-related laboratory parameters in&#xD;
      venous blood and urine, the results of an Electrocardiography (ECG), and the number,&#xD;
      severity, seriousness, clinical relevance, relatedness and outcome of Adverse Events (AEs).&#xD;
      The aim of the planned study is to demonstrate that SmofKabiven Peripheral is not inferior to&#xD;
      the comparative drug (compounded emulsion).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2017</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum Prealbumin</measure>
    <time_frame>6 days</time_frame>
    <description>Change in Serum Prealbumin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>C-reactive Protein (CRP)</measure>
    <time_frame>6 days</time_frame>
    <description>Change in CRP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linoleic acid</measure>
    <time_frame>6 days</time_frame>
    <description>Change in linoleic acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linolenic acid</measure>
    <time_frame>6 days</time_frame>
    <description>Change in linolenic acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arachidonic acid</measure>
    <time_frame>6 days</time_frame>
    <description>Change in arachidonic acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eicosapentaenoic acid (EPA)</measure>
    <time_frame>6 days</time_frame>
    <description>Change in EPA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Docosahexaenoic acis (DHA)</measure>
    <time_frame>6 days</time_frame>
    <description>Change in DHA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thromboxane B3 (TXB3)</measure>
    <time_frame>6 days</time_frame>
    <description>Change in TXB3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thromboxane B2 (TXB2)</measure>
    <time_frame>6 days</time_frame>
    <description>Change in TXB2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interleukin (IL)-1</measure>
    <time_frame>6 days</time_frame>
    <description>Change in IL-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-2</measure>
    <time_frame>6 days</time_frame>
    <description>Change in IL-2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-6</measure>
    <time_frame>6 days</time_frame>
    <description>Change in IL-6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cluster of Differentiation 4 (CD4) /Cluster of Differentiation 8 (CD8)</measure>
    <time_frame>6 days</time_frame>
    <description>Change in CD4/CD8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma amino acid (taurine)</measure>
    <time_frame>6 days</time_frame>
    <description>Change in plasma amino acid (taurine)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse Events (AE)</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Coded according to Medical Dictionary for Regulatory Affairs (MedDRA) by System Organ Class (SOC) and preferred term</description>
  </other_outcome>
  <other_outcome>
    <measure>Local intolerance for peripherally infusion</measure>
    <time_frame>6 days</time_frame>
    <description>Reported as AE</description>
  </other_outcome>
  <other_outcome>
    <measure>Development of phlebitis</measure>
    <time_frame>6 days</time_frame>
    <description>Reported as AE</description>
  </other_outcome>
  <other_outcome>
    <measure>Development of thrombophlebitis</measure>
    <time_frame>6 days</time_frame>
    <description>Reported as AE</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood pressure</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Vital signs</description>
  </other_outcome>
  <other_outcome>
    <measure>Heart rate</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Vital signs</description>
  </other_outcome>
  <other_outcome>
    <measure>Respiratory rate</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Vital signs</description>
  </other_outcome>
  <other_outcome>
    <measure>Body temperature</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Vital signs</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical examination</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Examination of abnormal findings in any system/organ</description>
  </other_outcome>
  <other_outcome>
    <measure>Red blood cell (RBC) count</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Total white blood cell (WBC) count</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Haemoglobin (Hb)</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Haematocrit (Hct)</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Platelets</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Creatinine</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Urea</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Sodium</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Potassium</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Magnesium</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Total calcium</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Chloride</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Phosphate</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Aspartate aminotransferase (AST)</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Alanine aminotransferase (ALT)</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Alkaline phosphatase (AP)</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Gamma-glutamyl transpeptidase (γ-GT)</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Lactate dehydrogenase (LDH)</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Total and direct bilirubin</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Albumin</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Total protein</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Glucose</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Cholesterol</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Triglycerides</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Low Density Lipoprotein (LDL)-C</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>High Density Lipoprotein (HDL)-C</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Fibrinogen</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Activated partial thromboplastin time (APTT)</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>Prothrombin time (PT)</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>International Normalised Ratio (INR)</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Laboratory variables</description>
  </other_outcome>
  <other_outcome>
    <measure>power of hydrogen (pH) value</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Urine analysis</description>
  </other_outcome>
  <other_outcome>
    <measure>Bilirubin</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Urine analysis</description>
  </other_outcome>
  <other_outcome>
    <measure>Protein</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Urine analysis</description>
  </other_outcome>
  <other_outcome>
    <measure>WBC</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Urine analysis</description>
  </other_outcome>
  <other_outcome>
    <measure>RBC</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Urine analysis</description>
  </other_outcome>
  <other_outcome>
    <measure>Urine Glucose</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Urine analysis</description>
  </other_outcome>
  <other_outcome>
    <measure>Ketone body</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Urine analysis</description>
  </other_outcome>
  <other_outcome>
    <measure>ECG</measure>
    <time_frame>up to 16 days</time_frame>
    <description>Electrocardiogram to assess cardiac disorders (e.g. Myocardial infarction, Pericarditis, QT interval Prolongation, etc.)</description>
  </other_outcome>
  <other_outcome>
    <measure>Preparation time</measure>
    <time_frame>5 days</time_frame>
    <description>Comparison of the time required for TPN preparation for the two groups</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">272</enrollment>
  <condition>Parenteral Feeding</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>SmofKabiven Peripheral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hospital compounded emulsion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SmofKabiven Peripheral</intervention_name>
    <description>Total Parenteral Nutrition</description>
    <arm_group_label>SmofKabiven Peripheral</arm_group_label>
    <other_name>Study intervention</other_name>
    <other_name>Investigational Product</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hospital compounded emulsion</intervention_name>
    <description>Total Parenteral Nutrition</description>
    <arm_group_label>Hospital compounded emulsion</arm_group_label>
    <other_name>Control</other_name>
    <other_name>Comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is scheduled to undergo elective abdominal surgery&#xD;
&#xD;
          2. Female or male patient, age between 18 and 75 years (inclusively)&#xD;
&#xD;
          3. Postoperatively, patient is expected to receive 100% of the total daily energy demand&#xD;
             via PN for at least 5 consecutive days&#xD;
&#xD;
          4. Body Mass Index (BMI) ≥ 16 and ≤ 30 kg /m2, and actual body weight ≥ 40 kg&#xD;
&#xD;
          5. Patient is capable to give Informed Consent, agrees to participate in the study, and&#xD;
             signs the Informed Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient has received PN or parenteral amino acids in the last 10 days before&#xD;
             randomization (exception: administration of glucose will be allowed)&#xD;
&#xD;
          2. Severe liver insufficiency or AST, ALT or total bilirubin at least 1.5-times higher&#xD;
             than the upper limit of normal range&#xD;
&#xD;
          3. International Normalised Ratio (INR) at least 1.5 times higher than the upper limit of&#xD;
             normal range&#xD;
&#xD;
          4. Uncontrolled hyperglycaemia, fasting blood glucose &gt; 180 mg/ dl (10 mmol/L)&#xD;
&#xD;
          5. Severe renal impairment defined as serum creatinine value at least 1.5 times higher&#xD;
             than the upper limit of normal range&#xD;
&#xD;
          6. Serious hyperlipidaemia (serum cholesterol and/or triglycerides and/or LDL-C level at&#xD;
             least 1.5 times higher than the upper limit of normal range)&#xD;
&#xD;
          7. Inborn abnormality of amino acid metabolism&#xD;
&#xD;
          8. Present signs of acute pancreatitis, hypothyroidism or hyper-thyroidism as diagnosed&#xD;
             clinically&#xD;
&#xD;
          9. Serum level of any of the electrolytes (sodium, potassium, magnesium, total calcium,&#xD;
             chloride, phosphate) above the upper limit of the normal range&#xD;
&#xD;
         10. Known unstable metabolism (e.g., known metabolic acidosis)&#xD;
&#xD;
         11. Known hypersensitivity to fish-, egg-, soybean, or peanut protein or to any of the&#xD;
             active substances or excipients of the study drugs&#xD;
&#xD;
         12. General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration,&#xD;
             and decompensated cardiac insufficiency /congestive heart failure&#xD;
&#xD;
         13. Unstable conditions (e.g., acute myocardial infarction, stroke, embolism, severe&#xD;
             sepsis, shock)&#xD;
&#xD;
         14. Drug abuse and/or chronic alcoholism&#xD;
&#xD;
         15. Psychiatric diseases, epilepsy&#xD;
&#xD;
         16. Administration of growth hormones within the previous 4 weeks before surgery, or&#xD;
             chronic maintenance therapy with systemic glucocorticoids 4 weeks before surgery&#xD;
&#xD;
         17. Participation in a clinical study with an investigational drug or an investigational&#xD;
             medical device within one month prior to start of study or during study&#xD;
&#xD;
         18. Patient is pregnant or lactating and intends to continue breast-feeding&#xD;
&#xD;
         19. Development of intraoperative/ postoperative conditions (assessed after surgery and&#xD;
             before enrollment of patients):&#xD;
&#xD;
               1. Intra-operative blood loss &gt; 1000ml;&#xD;
&#xD;
               2. Development of a condition in which PN is contraindicated;&#xD;
&#xD;
               3. Intra- or postoperative urine output &lt;0.5 ml/kg/h;&#xD;
&#xD;
               4. Need for postoperative haemo-filtration or dialysis;&#xD;
&#xD;
               5. Contraindication or inability to obtain peripheral or central venous catheter&#xD;
                  access;&#xD;
&#xD;
               6. Intra-operative decision on limited treatment, e.g. due to diagnosis of&#xD;
                  carcinomatosis;&#xD;
&#xD;
               7. Intra-operative severe complications including resuscitation, hemorrhagic and&#xD;
                  septic shock, acute single and multiple organ dysfunction including pulmonary,&#xD;
                  hepatic, and renal dysfunction prohibiting early postsurgical extubation,&#xD;
                  requiring liver-specific treatment and renal replacement therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wu Guohao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Friendship Hospital Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital with Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Qingdao University</name>
      <address>
        <city>Qingdao</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002925.pdf</url>
    <description>International Council for Harmonisation (ICH) E10 'Note for Guidance on Choice of Control Group', July 2000</description>
  </link>
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    <PMID>15736910</PMID>
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  <reference>
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  <reference>
    <citation>Grimm H, Mertes N, Goeters C, Schlotzer E, Mayer K, Grimminger F, Furst P. Improved fatty acid and leukotriene pattern with a novel lipid emulsion in surgical patients. Eur J Nutr. 2006 Feb;45(1):55-60. doi: 10.1007/s00394-005-0573-8. Epub 2005 Jul 22.</citation>
    <PMID>16041475</PMID>
  </reference>
  <reference>
    <citation>Puder M, Valim C, Meisel JA, Le HD, de Meijer VE, Robinson EM, Zhou J, Duggan C, Gura KM. Parenteral fish oil improves outcomes in patients with parenteral nutrition-associated liver injury. Ann Surg. 2009 Sep;250(3):395-402. doi: 10.1097/SLA.0b013e3181b36657.</citation>
    <PMID>19661785</PMID>
  </reference>
  <reference>
    <citation>Gura KM, Duggan CP, Collier SB, Jennings RW, Folkman J, Bistrian BR, Puder M. Reversal of parenteral nutrition-associated liver disease in two infants with short bowel syndrome using parenteral fish oil: implications for future management. Pediatrics. 2006 Jul;118(1):e197-201. doi: 10.1542/peds.2005-2662.</citation>
    <PMID>16818533</PMID>
  </reference>
  <reference>
    <citation>Alwayn IP, Gura K, Nose V, Zausche B, Javid P, Garza J, Verbesey J, Voss S, Ollero M, Andersson C, Bistrian B, Folkman J, Puder M. Omega-3 fatty acid supplementation prevents hepatic steatosis in a murine model of nonalcoholic fatty liver disease. Pediatr Res. 2005 Mar;57(3):445-52. doi: 10.1203/01.PDR.0000153672.43030.75. Epub 2005 Jan 19.</citation>
    <PMID>15659701</PMID>
  </reference>
  <reference>
    <citation>Bouletreau P, Chassard D, Allaouchiche B, Dumont JC, Auboyer C, Bertin-Maghit M, Bricard H, Ecochard R, Rangaraj J, Chambrier C, Schneid C, Cynober L. Glucose-lipid ratio is a determinant of nitrogen balance during total parenteral nutrition in critically ill patients: a prospective, randomized, multicenter blind trial with an intention-to-treat analysis. Intensive Care Med. 2005 Oct;31(10):1394-400. doi: 10.1007/s00134-005-2771-5. Epub 2005 Aug 24.</citation>
    <PMID>16132885</PMID>
  </reference>
  <reference>
    <citation>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. doi: 10.1038/sj.ejcn.1602289.</citation>
    <PMID>16234837</PMID>
  </reference>
  <reference>
    <citation>Shenkin A. Serum prealbumin: Is it a marker of nutritional status or of risk of malnutrition? Clin Chem. 2006 Dec;52(12):2177-9. doi: 10.1373/clinchem.2006.077412. No abstract available.</citation>
    <PMID>17138848</PMID>
  </reference>
  <reference>
    <citation>Young GA, Hill GL. Assessment of protein-calorie malnutrition in surgical patients from plasma proteins and anthropometric measurements. Am J Clin Nutr. 1978 Mar;31(3):429-35. doi: 10.1093/ajcn/31.3.429.</citation>
    <PMID>415592</PMID>
  </reference>
  <reference>
    <citation>Young GA, Collins JP, Hill GL. Plasma proteins in patients receiving intravenous amino acids or intravenous hyperalimentation after major surgery. Am J Clin Nutr. 1979 Jun;32(6):1192-9. doi: 10.1093/ajcn/32.6.1192.</citation>
    <PMID>87126</PMID>
  </reference>
  <reference>
    <citation>Young GA, Hill GL. A controlled study of protein-sparing therapy after excision of the rectum: effects of intravenous amino acids and hyperalimentation on body composition and plasma amino acids. Ann Surg. 1980 Aug;192(2):183-91. doi: 10.1097/00000658-198008000-00009.</citation>
    <PMID>6773484</PMID>
  </reference>
  <reference>
    <citation>Chinese medical clinical guidelines parenteral enteral nutrition 2008, edited by Chinese Medical Association, People's Medical Publishing House.</citation>
  </reference>
  <reference>
    <citation>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. doi: 10.1515/CCLM.2007.334. No abstract available.</citation>
    <PMID>17970714</PMID>
  </reference>
  <reference>
    <citation>SSPC. Intralipid 20%, Summary of Product Characteristics, dated 14 February 2007</citation>
  </reference>
  <reference>
    <citation>SSPC. Novamin 11.4%, Summary of Product Characteristics, dated 01 December 2013</citation>
  </reference>
  <reference>
    <citation>McClave SA, Martindale RG, Vanek VW, McCarthy M, Roberts P, Taylor B, Ochoa JB, Napolitano L, Cresci G; A.S.P.E.N. Board of Directors; American College of Critical Care Medicine; Society of Critical Care Medicine. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):277-316. doi: 10.1177/0148607109335234. No abstract available.</citation>
    <PMID>19398613</PMID>
  </reference>
  <reference>
    <citation>Braga M, Ljungqvist O, Soeters P, Fearon K, Weimann A, Bozzetti F; ESPEN. ESPEN Guidelines on Parenteral Nutrition: surgery. Clin Nutr. 2009 Aug;28(4):378-86. doi: 10.1016/j.clnu.2009.04.002. Epub 2009 May 21.</citation>
    <PMID>19464088</PMID>
  </reference>
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    <citation>Chowdary KV, Reddy PN. Parenteral nutrition: Revisited. Indian J Anaesth. 2010 Mar;54(2):95-103. doi: 10.4103/0019-5049.63637.</citation>
    <PMID>20661345</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19505748</PMID>
  </reference>
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    <citation>Fresenius Kabi. SomfKabiven Peripheral, emulsion for infusion. Summary of Product Characteristics, dated September.29. 2009</citation>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SmofKabiven</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Parenteral</keyword>
  <keyword>Abdominal surgery</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03792087
org study id: SMKV-011-CP3
nct id: NCT03792087
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Serum Prealbumin
time frame: 6 days
description: Change in Serum Prealbumin
measure: C-reactive Protein (CRP)
time frame: 6 days
description: Change in CRP
measure: Linoleic acid
time frame: 6 days
description: Change in linoleic acid
measure: Linolenic acid
time frame: 6 days
description: Change in linolenic acid
measure: Arachidonic acid
time frame: 6 days
description: Change in arachidonic acid
measure: Eicosapentaenoic acid (EPA)
time frame: 6 days
description: Change in EPA
measure: Docosahexaenoic acis (DHA)
time frame: 6 days
description: Change in DHA
measure: Thromboxane B3 (TXB3)
time frame: 6 days
description: Change in TXB3
measure: Thromboxane B2 (TXB2)
time frame: 6 days
description: Change in TXB2
measure: Interleukin (IL)-1
time frame: 6 days
description: Change in IL-1
measure: IL-2
time frame: 6 days
description: Change in IL-2
measure: IL-6
time frame: 6 days
description: Change in IL-6
measure: Cluster of Differentiation 4 (CD4) /Cluster of Differentiation 8 (CD8)
time frame: 6 days
description: Change in CD4/CD8
measure: Plasma amino acid (taurine)
time frame: 6 days
description: Change in plasma amino acid (taurine)
measure: Adverse Events (AE)
time frame: up to 16 days
description: Coded according to Medical Dictionary for Regulatory Affairs (MedDRA) by System Organ Class (SOC) and preferred term
measure: Local intolerance for peripherally infusion
time frame: 6 days
description: Reported as AE
measure: Development of phlebitis
time frame: 6 days
description: Reported as AE
measure: Development of thrombophlebitis
time frame: 6 days
description: Reported as AE
measure: Blood pressure
time frame: up to 16 days
description: Vital signs
measure: Heart rate
time frame: up to 16 days
description: Vital signs
measure: Respiratory rate
time frame: up to 16 days
description: Vital signs
measure: Body temperature
time frame: up to 16 days
description: Vital signs
measure: Physical examination
time frame: up to 16 days
description: Examination of abnormal findings in any system/organ
measure: Red blood cell (RBC) count
time frame: up to 16 days
description: Laboratory variables
measure: Total white blood cell (WBC) count
time frame: up to 16 days
description: Laboratory variables
measure: Haemoglobin (Hb)
time frame: up to 16 days
description: Laboratory variables
measure: Haematocrit (Hct)
time frame: up to 16 days
description: Laboratory variables
measure: Platelets
time frame: up to 16 days
description: Laboratory variables
measure: Creatinine
time frame: up to 16 days
description: Laboratory variables
measure: Urea
time frame: up to 16 days
description: Laboratory variables
measure: Sodium
time frame: up to 16 days
description: Laboratory variables
measure: Potassium
time frame: up to 16 days
description: Laboratory variables
measure: Magnesium
time frame: up to 16 days
description: Laboratory variables
measure: Total calcium
time frame: up to 16 days
description: Laboratory variables
measure: Chloride
time frame: up to 16 days
description: Laboratory variables
measure: Phosphate
time frame: up to 16 days
description: Laboratory variables
measure: Aspartate aminotransferase (AST)
time frame: up to 16 days
description: Laboratory variables
measure: Alanine aminotransferase (ALT)
time frame: up to 16 days
description: Laboratory variables
measure: Alkaline phosphatase (AP)
time frame: up to 16 days
description: Laboratory variables
measure: Gamma-glutamyl transpeptidase (γ-GT)
time frame: up to 16 days
description: Laboratory variables
measure: Lactate dehydrogenase (LDH)
time frame: up to 16 days
description: Laboratory variables
measure: Total and direct bilirubin
time frame: up to 16 days
description: Laboratory variables
measure: Albumin
time frame: up to 16 days
description: Laboratory variables
measure: Total protein
time frame: up to 16 days
description: Laboratory variables
measure: Glucose
time frame: up to 16 days
description: Laboratory variables
measure: Cholesterol
time frame: up to 16 days
description: Laboratory variables
measure: Triglycerides
time frame: up to 16 days
description: Laboratory variables
measure: Low Density Lipoprotein (LDL)-C
time frame: up to 16 days
description: Laboratory variables
measure: High Density Lipoprotein (HDL)-C
time frame: up to 16 days
description: Laboratory variables
measure: Fibrinogen
time frame: up to 16 days
description: Laboratory variables
measure: Activated partial thromboplastin time (APTT)
time frame: up to 16 days
description: Laboratory variables
measure: Prothrombin time (PT)
time frame: up to 16 days
description: Laboratory variables
measure: International Normalised Ratio (INR)
time frame: up to 16 days
description: Laboratory variables
measure: power of hydrogen (pH) value
time frame: up to 16 days
description: Urine analysis
measure: Bilirubin
time frame: up to 16 days
description: Urine analysis
measure: Protein
time frame: up to 16 days
description: Urine analysis
measure: WBC
time frame: up to 16 days
description: Urine analysis
measure: RBC
time frame: up to 16 days
description: Urine analysis
measure: Urine Glucose
time frame: up to 16 days
description: Urine analysis
measure: Ketone body
time frame: up to 16 days
description: Urine analysis
measure: ECG
time frame: up to 16 days
description: Electrocardiogram to assess cardiac disorders (e.g. Myocardial infarction, Pericarditis, QT interval Prolongation, etc.)
measure: Preparation time
time frame: 5 days
description: Comparison of the time required for TPN preparation for the two groups
arm group label: SmofKabiven Peripheral
arm group type: Experimental
description: 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.
arm group label: Hospital compounded emulsion
arm group type: Active Comparator
description: 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.
intervention type: Drug
intervention name: SmofKabiven Peripheral
description: Total Parenteral Nutrition
arm group label: SmofKabiven Peripheral
other name: Study intervention
other name: Investigational Product
intervention type: Drug
intervention name: Hospital compounded emulsion
description: Total Parenteral Nutrition
arm group label: Hospital compounded emulsion
other name: Control
other name: Comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Wu Guohao, MD
role: Principal Investigator
affiliation: Fudan University
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
url: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002925.pdf
description: International Council for Harmonisation (ICH) E10 'Note for Guidance on Choice of Control Group', July 2000
citation: Calder PC. n-3 fatty acids, inflammation, and immunity--relevance to postsurgical and critically ill patients. Lipids. 2004 Dec;39(12):1147-61. doi: 10.1007/s11745-004-1342-z.
PMID: 15736910
citation: Mayer K, Gokorsch S, Fegbeutel C, Hattar K, Rosseau S, Walmrath D, Seeger W, Grimminger F. Parenteral nutrition with fish oil modulates cytokine response in patients with sepsis. Am J Respir Crit Care Med. 2003 May 15;167(10):1321-8. doi: 10.1164/rccm.200207-674OC. Epub 2003 Feb 25.
PMID: 12615625
citation: Novak TE, Babcock TA, Jho DH, Helton WS, Espat NJ. NF-kappa B inhibition by omega -3 fatty acids modulates LPS-stimulated macrophage TNF-alpha transcription. Am J Physiol Lung Cell Mol Physiol. 2003 Jan;284(1):L84-9. doi: 10.1152/ajplung.00077.2002. Epub 2002 Aug 30.
PMID: 12388359
citation: Pluess TT, Hayoz D, Berger MM, Tappy L, Revelly JP, Michaeli B, Carpentier YA, Chiolero RL. Intravenous fish oil blunts the physiological response to endotoxin in healthy subjects. Intensive Care Med. 2007 May;33(5):789-797. doi: 10.1007/s00134-007-0591-5. Epub 2007 Mar 22. Erratum In: Intensive Care Med. 2007 Jul;33(7):1310.
PMID: 17377770
citation: Xiong J, Zhu S, Zhou Y, Wu H, Wang C. Regulation of omega-3 fish oil emulsion on the SIRS during the initial stage of severe acute pancreatitis. J Huazhong Univ Sci Technolog Med Sci. 2009 Feb;29(1):35-8. doi: 10.1007/s11596-009-0107-3. Epub 2009 Feb 18.
PMID: 19224159
citation: Helmut Grimm, A balanced lipid emulsion-A new concept in parenteral nutrition. Clinical Nutrition Supplements (2005) 1, 25-30.
citation: Grimm H, Mertes N, Goeters C, Schlotzer E, Mayer K, Grimminger F, Furst P. Improved fatty acid and leukotriene pattern with a novel lipid emulsion in surgical patients. Eur J Nutr. 2006 Feb;45(1):55-60. doi: 10.1007/s00394-005-0573-8. Epub 2005 Jul 22.
PMID: 16041475
citation: Puder M, Valim C, Meisel JA, Le HD, de Meijer VE, Robinson EM, Zhou J, Duggan C, Gura KM. Parenteral fish oil improves outcomes in patients with parenteral nutrition-associated liver injury. Ann Surg. 2009 Sep;250(3):395-402. doi: 10.1097/SLA.0b013e3181b36657.
PMID: 19661785
citation: Gura KM, Duggan CP, Collier SB, Jennings RW, Folkman J, Bistrian BR, Puder M. Reversal of parenteral nutrition-associated liver disease in two infants with short bowel syndrome using parenteral fish oil: implications for future management. Pediatrics. 2006 Jul;118(1):e197-201. doi: 10.1542/peds.2005-2662.
PMID: 16818533
citation: Alwayn IP, Gura K, Nose V, Zausche B, Javid P, Garza J, Verbesey J, Voss S, Ollero M, Andersson C, Bistrian B, Folkman J, Puder M. Omega-3 fatty acid supplementation prevents hepatic steatosis in a murine model of nonalcoholic fatty liver disease. Pediatr Res. 2005 Mar;57(3):445-52. doi: 10.1203/01.PDR.0000153672.43030.75. Epub 2005 Jan 19.
PMID: 15659701
citation: Bouletreau P, Chassard D, Allaouchiche B, Dumont JC, Auboyer C, Bertin-Maghit M, Bricard H, Ecochard R, Rangaraj J, Chambrier C, Schneid C, Cynober L. Glucose-lipid ratio is a determinant of nitrogen balance during total parenteral nutrition in critically ill patients: a prospective, randomized, multicenter blind trial with an intention-to-treat analysis. Intensive Care Med. 2005 Oct;31(10):1394-400. doi: 10.1007/s00134-005-2771-5. Epub 2005 Aug 24.
PMID: 16132885
citation: 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. doi: 10.1038/sj.ejcn.1602289.
PMID: 16234837
citation: Shenkin A. Serum prealbumin: Is it a marker of nutritional status or of risk of malnutrition? Clin Chem. 2006 Dec;52(12):2177-9. doi: 10.1373/clinchem.2006.077412. No abstract available.
PMID: 17138848
citation: Young GA, Hill GL. Assessment of protein-calorie malnutrition in surgical patients from plasma proteins and anthropometric measurements. Am J Clin Nutr. 1978 Mar;31(3):429-35. doi: 10.1093/ajcn/31.3.429.
PMID: 415592
citation: Young GA, Collins JP, Hill GL. Plasma proteins in patients receiving intravenous amino acids or intravenous hyperalimentation after major surgery. Am J Clin Nutr. 1979 Jun;32(6):1192-9. doi: 10.1093/ajcn/32.6.1192.
PMID: 87126
citation: Young GA, Hill GL. A controlled study of protein-sparing therapy after excision of the rectum: effects of intravenous amino acids and hyperalimentation on body composition and plasma amino acids. Ann Surg. 1980 Aug;192(2):183-91. doi: 10.1097/00000658-198008000-00009.
PMID: 6773484
citation: Chinese medical clinical guidelines parenteral enteral nutrition 2008, edited by Chinese Medical Association, People's Medical Publishing House.
citation: 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. doi: 10.1515/CCLM.2007.334. No abstract available.
PMID: 17970714
citation: SSPC. Intralipid 20%, Summary of Product Characteristics, dated 14 February 2007
citation: SSPC. Novamin 11.4%, Summary of Product Characteristics, dated 01 December 2013
citation: McClave SA, Martindale RG, Vanek VW, McCarthy M, Roberts P, Taylor B, Ochoa JB, Napolitano L, Cresci G; A.S.P.E.N. Board of Directors; American College of Critical Care Medicine; Society of Critical Care Medicine. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):277-316. doi: 10.1177/0148607109335234. No abstract available.
PMID: 19398613
citation: Braga M, Ljungqvist O, Soeters P, Fearon K, Weimann A, Bozzetti F; ESPEN. ESPEN Guidelines on Parenteral Nutrition: surgery. Clin Nutr. 2009 Aug;28(4):378-86. doi: 10.1016/j.clnu.2009.04.002. Epub 2009 May 21.
PMID: 19464088
citation: Chowdary KV, Reddy PN. Parenteral nutrition: Revisited. Indian J Anaesth. 2010 Mar;54(2):95-103. doi: 10.4103/0019-5049.63637.
PMID: 20661345
citation: 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.
PMID: 19505748
citation: Fresenius Kabi. SomfKabiven Peripheral, emulsion for infusion. Summary of Product Characteristics, dated September.29. 2009
responsible party type: Sponsor