Clincosm LogoSign in Get a demo

Efficacy & Safety of SmofKabiven Emulsion for Infusion vs Hospital Compounded "All in One" for Parenteral Nutrition

Sponsor
Fresenius Kabi (Industry)
Overall Status
Completed
CT.gov ID
NCT03792100
Collaborator
Parexel (Industry)
273
Enrollment
8
Locations
2
Arms
12.6
Actual Duration (Months)
34.1
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present protocol describes a randomized, patient-blinded study in which either SmofKabiven emulsion for infusion or a hospital compounded "All in one" control Total Parenteral Nutrition (TPN) 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 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
  • Drug: SmofKabiven emulsion for infusion
  • Drug: Hospital compounded "All in one" emulsion
 Phase 3

Detailed Description

In addition, other variables will be assessed in this study, i.e., postsurgical new onset of nosocomial infection, CRP, free fatty acids, immunology parameters, 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 emulsion for infusion is not inferior to the comparative drug (hospital compounded "All in one" emulsion for parenteral nutrition).

Study Design

Study Type:
Interventional
Actual Enrollment :
273 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Allocation to the treatment arms will not be known to the patient
Primary Purpose:
Treatment
Official Title:
Efficacy & Safety of SmofKabiven Emulsion for Infusion vs Hospital Compounded "All in One" for Parenteral Nutrition (PN): A Randomized, Active-Controlled, Patient-blinded, Multi-Centre Study in Adult Surgical Patients Requiring PN
Actual Study Start Date :
Jan 3, 2019
Actual Primary Completion Date :
Jan 23, 2020
Actual Study Completion Date :
Jan 23, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: SmofKabiven emulsion for infusion

SmofKabiven emulsion for infusion will be continuously infused intravenously via central venous access for approximately 14-24 h/d. Duration of treatment with the study drug is 5 consecutive days.Targeted daily dose is 26.3 ml/kg bw/day resulting in 29.3 kcal/kg bw/day. Dosage on D 1 will be reduced to 50%.

Drug: SmofKabiven emulsion for infusion
Total Parenteral Nutrition
Other Names:
  • Study intervention
  • Investigational Product

    		•
    Active Comparator: Hospital compounded "All in one" emulsion for PN

    Hospital compounded "All in one" emulsion will be continuously infused intravenously via central venous access for approximately 14-24 h/d. Duration of treatment with the study drugs will be 5 consecutive days.Targeted daily dose is 26.3 ml/kg bw/day resulting in 29.3 kcal/kg bw/day. Dosage on D 1 will be reduced to 50%.

    Drug: Hospital compounded "All in one" emulsion
    Total Parenteral Nutrition
    Other Names:
  • Control
  • Comparator

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum Prealbumin [6 days]

      Change in Serum Prealbumin

    Secondary Outcome Measures

    1. Nosocomial infection [6 days]

      Postsurgical new onset of nosocomial infection

    2. Prealbumin [4 days]

      Change in Prealbumin

    3. C-reactive Protein (CRP) [6 days]

      Change in CRP

    4. Linoleic acid [6 days]

      Change in linoleic acid

    5. Linolenic acid [6 days]

      Change in linolenic acid

    6. Arachidonic acid [6 days]

      Change in arachidonic acid

    7. Eicosapentaenoic acid (EPA) [6 days]

      Change in EPA

    8. Docosahexaenoic acis (DHA) [6 days]

      Change in DHA

    9. Thromboxane B3 (TX B3) / Thromboxane B2 (TX B2) [6 days]

      Change in TX B3/B2

    10. Interleukin (IL)-1 [6 days]

      Change in IL-1

    11. Interleukin (IL)-2 [6 days]

      Change in IL-2

    12. Interleukin (IL)-6 [6 days]

      Change in IL-6

    13. Cluster of Differentiation 4 (CD4) / Cluster of Differentiation 8 (CD8) [6 days]

      Change in CD4/CD8

    14. Plasma amino acid (taurine) [6 days]

      Change in taurine

    Other Outcome Measures

    1. Adverse Events (AE) [up to 16 days]

      Coded according to Medical Dictionary for Regulatory Affairs (MedDRA) by System Organ Class (SOC) and preferred term

    2. Blood pressure [up to 16 days]

      Vital signs

    3. Heart rate [up to 16 days]

      Vital signs

    4. Respiratory rate [up to 16 days]

      Vital signs

    5. Axillary body temperature [up to 16 days]

      Vital signs

    6. Physical examination [up to 16 days]

      Examination of abnormal findings in any system/organ

    7. Red blood cell (RBC) count [up to 16 days]

      Laboratory variable

    8. Total white blood cell (WBC) count [up to 16 days]

      Laboratory variable

    9. Haemoglobin (Hb) [up to 16 days]

      Laboratory variable

    10. Haematocrit (Hct) [up to 16 days]

      Laboratory variable

    11. Platelets [up to 16 days]

      Laboratory variable

    12. Creatinine [up to 16 days]

      Laboratory variable

    13. Urea [up to 16 days]

      Laboratory variable

    14. Sodium [up to 16 days]

      Laboratory variable

    15. Potassium [up to 16 days]

      Laboratory variable

    16. Magnesium [up to 16 days]

      Laboratory variable

    17. Total calcium [up to 16 days]

      Laboratory variable

    18. Chloride [up to 16 days]

      Laboratory variable

    19. Phosphate [up to 16 days]

      Laboratory variable

    20. Aspartate aminotransferase (AST) [up to 16 days]

      Laboratory variable

    21. Alanine aminotransferase (ALT) [up to 16 days]

      Laboratory variable

    22. Alkaline phosphatase (AP) [up to 16 days]

      Laboratory variable

    23. Gamma-glutamyl transpeptidase (γ-GT) [up to 16 days]

      Laboratory variable

    24. Lactate dehydrogenase (LDH) [up to 16 days]

      Laboratory variable

    25. Total and direct bilirubin [up to 16 days]

      Laboratory variable

    26. Albumin [up to 16 days]

      Laboratory variable

    27. Total protein [up to 16 days]

      Laboratory variable

    28. Glucose [up to 16 days]

      Laboratory variable

    29. Cholesterol [up to 16 days]

      Laboratory variable

    30. Triglycerides [up to 16 days]

      Laboratory variable

    31. Low Density Lipoprotein (LDL)-C [up to 16 days]

      Laboratory variable

    32. High Density Lipoprotein (HDL)-C [up to 16 days]

      Laboratory variable

    33. Fibrinogen [up to 16 days]

      Laboratory variable

    34. Activated partial thromboplastin time (APTT) [up to 16 days]

      Laboratory variable

    35. Prothrombin time (PT) [up to 16 days]

      Laboratory variable

    36. International Normalised Ratio (INR) [up to 16 days]

      Laboratory variable

    37. Power of water (pH) value [up to 16 days]

      Urine analysis

    38. Bilirubin [up to 16 days]

      Urine analysis

    39. Protein [up to 16 days]

      Urine analysis

    40. White Blood Cell (WBC) [up to 16 days]

      Urine analysis

    41. Red Blood Cell (RBC) [up to 16 days]

      Urine analysis

    42. Urine Glucose [up to 16 days]

      Urine analysis

    43. Ketone body [up to 16 days]

      Urine analysis

    44. Electrocardiogram (ECG) [up to 16 days]

      Electrocardiogram to assess cardiac disorders (e.g. Myocardial infarction, Pericarditis, QT interval Prolongation, etc.)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patient is scheduled to undergo elective gastrointestinal surgery;

    2. Female or male patients, age ≥ 18 and ≤ 80 years;

    3. Postoperatively, patient is expected to receive 100% of the total daily energy demand via PN for at least 5 consecutive days;

    4. Body Mass Index (BMI) ≥ 16 kg/m2 and ≤ 30 kg /m2, and actual body weight ≥ 40 kg;

    5. Patient is capable to give Informed Consent, agrees to participate in the study, and signs the Informed Consent Form.

    Exclusion Criteria:

    1. Patient has received PN or parenteral amino acids in the last 10 days before randomization (exception: administration of glucose will be allowed);

    2. Known severe liver insufficiency in the medical history, or AST or ALT at least 3.0-times higher than the upper limit of normal range or total bilirubin at least 1.5-times higher than the upper limit of normal range;

    3. International Normalised Ratio (INR) at least 1.5 times higher than the upper limit of normal range;

    4. Uncontrolled hyperglycaemia defined as fasting blood glucose > 180 mg/ dl (10 mmol/L);

    5. Severe renal impairment defined as serum creatinine value at least 1.5 times higher than the upper limit of normal range;

    6. 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);

    7. Known inborn abnormality of amino acid metabolism in the medical history;

    8. Known acute pancreatitis in the medical history;

    9. Known hypothyroidism or hyperthyroidism in the medical history;

    10. Serum level of any of the electrolytes (sodium, potassium, magnesium, total calcium, chloride, phosphate) above the upper limit of the normal range;

    11. Known unstable metabolism in the medical history (e.g., metabolic acidosis);

    12. Known hypersensitivity to fish, egg, soybean, or peanut protein or to any of the active substances or excipients of the study drugs in the medical history;

    13. General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency /congestive heart failure;

    14. Unstable haemodynamic conditions (e.g., acute myocardial infarction, stroke, embolism, severe sepsis, shock);

    15. Known hemophagocytic syndrome;

    16. Patients diagnosed with an infection before the surgery;

    17. Drug abuse and/or chronic alcoholism;

    18. Psychiatric diseases, epilepsy;

    19. Administration of growth hormones within the previous 4 weeks before surgery, or chronic maintenance therapy with systemic glucocorticoids 4 weeks before surgery;

    20. 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;

    21. Patient is pregnant or lactating and intends to continue breast-feeding;

    22. Development of intraoperative/ postoperative conditions (assessed after surgery and before enrolment of patients):

    23. Intra-operative blood loss > 1000 ml;

    24. Development of a condition in which PN is contraindicated;

    25. Intra- or postoperative urine output < 0.5 ml/kg/h;

    26. Need for postoperative haemofiltration or dialysis;

    27. Contraindication or inability to obtain central venous catheter access;

    28. Intra-operative decision on limited treatment, e.g. due to diagnosis of carcinomatosis;

    29. 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 The Second Hospital of Jilin University Changchun China
    3 The First Affiliated Hospital of Guangzhou Medical University Guangzhou China
    4 Thepeople's hospital of Guangxi zhuang Nanning China
    5 Shanghai First People's hospital Shanghai China
    6 Shanghai Pudong Hospital Shanghai China
    7 Zhongshan Hospital Fudan University Shanghai China
    8 Shanxi Provincial People's Hospital Taiyuan China

    Sponsors and Collaborators

    • Fresenius Kabi
    • Parexel

    Investigators

    • Principal Investigator: Zhang Zhongtao, MD, Beijing Friendship Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Fresenius Kabi
    ClinicalTrials.gov Identifier:
    NCT03792100
    Other Study ID Numbers:
    • SMKV-015-CP3
    First Posted:
    Jan 3, 2019
    Last Update Posted:
    Aug 2, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fresenius Kabi
    SmofKabiven
    Abdominal surgery
    Parenteral
    Nutrition

    Study Results

    No Results Posted as of Aug 2, 2021