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Trial record 62 of 359 for:    transthyretin

Efficacy and Safety of SmofKabiven Peripheral Versus Compounded Emulsion

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ClinicalTrials.gov Identifier: NCT03792087
Recruitment Status : Completed
First Posted : January 3, 2019
Last Update Posted : February 11, 2019
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Fresenius Kabi

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. 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).

Condition or disease Intervention/treatment Phase
Parenteral Feeding Surgery Drug: SmofKabiven Peripheral Drug: Hospital compounded emulsion Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of SmofKabiven Peripheral [Multi-oil Fat Emulsion (C6-24)/Amino Acids (16)/Glucose (13%) and Electrolyte Injection] Versus Compounded Emulsion: A Randomized, Active-Controlled, Open-Labelled, Multi-Centre Study in Adult Surgical Patients Requiring Parenteral Nutrition
Actual Study Start Date : December 21, 2017
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. Serum Prealbumin [ Time Frame: 6 days ]
    Change in Serum Prealbumin


Secondary Outcome Measures :
  1. C-reactive Protein (CRP) [ Time Frame: 6 days ]
    Change in CRP

  2. Linoleic acid [ Time Frame: 6 days ]
    Change in linoleic acid

  3. Linolenic acid [ Time Frame: 6 days ]
    Change in linolenic acid

  4. Arachidonic acid [ Time Frame: 6 days ]
    Change in arachidonic acid

  5. Eicosapentaenoic acid (EPA) [ Time Frame: 6 days ]
    Change in EPA

  6. Docosahexaenoic acis (DHA) [ Time Frame: 6 days ]
    Change in DHA

  7. Thromboxane B3 (TXB3) [ Time Frame: 6 days ]
    Change in TXB3

  8. Thromboxane B2 (TXB2) [ Time Frame: 6 days ]
    Change in TXB2

  9. Interleukin (IL)-1 [ Time Frame: 6 days ]
    Change in IL-1

  10. IL-2 [ Time Frame: 6 days ]
    Change in IL-2

  11. IL-6 [ Time Frame: 6 days ]
    Change in IL-6

  12. Cluster of Differentiation 4 (CD4) /Cluster of Differentiation 8 (CD8) [ Time Frame: 6 days ]
    Change in CD4/CD8

  13. Plasma amino acid (taurine) [ Time Frame: 6 days ]
    Change in plasma amino acid (taurine)


Other Outcome Measures:
  1. Adverse Events (AE) [ Time Frame: up to 16 days ]
    Coded according to Medical Dictionary for Regulatory Affairs (MedDRA) by System Organ Class (SOC) and preferred term

  2. Local intolerance for peripherally infusion [ Time Frame: 6 days ]
    Reported as AE

  3. Development of phlebitis [ Time Frame: 6 days ]
    Reported as AE

  4. Development of thrombophlebitis [ Time Frame: 6 days ]
    Reported as AE

  5. Blood pressure [ Time Frame: up to 16 days ]
    Vital signs

  6. Heart rate [ Time Frame: up to 16 days ]
    Vital signs

  7. Respiratory rate [ Time Frame: up to 16 days ]
    Vital signs

  8. Body temperature [ Time Frame: up to 16 days ]
    Vital signs

  9. Physical examination [ Time Frame: up to 16 days ]
    Examination of head to identify medically significant aberrance

  10. Physical examination [ Time Frame: up to 16 days ]
    Examination of mouth to to identify medically significant aberrance

  11. Physical examination [ Time Frame: up to 16 days ]
    Examination of nose, to identify medically significant aberrance

  12. Physical examination [ Time Frame: up to 16 days ]
    Examination of throat to identify medically significant aberrance

  13. Physical examination [ Time Frame: up to 16 days ]
    Examination tonsils to identify medically significant aberrance

  14. Physical examination [ Time Frame: up to 16 days ]
    Examination of ears to identify medically significant aberrance

  15. Physical examination [ Time Frame: up to 16 days ]
    Examination of eyes to identify medically significant aberrance

  16. Physical examination [ Time Frame: up to 16 days ]
    Examination of neck to identify medically significant aberrance

  17. Physical examination [ Time Frame: up to 16 days ]
    Palpation of lymph nodes to identify medically significant aberrance

  18. Physical examination [ Time Frame: up to 16 days ]
    Auscultation of lungs and chest to identify medically significant aberrance

  19. Physical examination [ Time Frame: up to 16 days ]
    Palpation of breasts to identify medically significant aberrance

  20. Physical examination [ Time Frame: up to 16 days ]
    Examination of cardiovascular system to identify medically significant aberrance

  21. Physical examination [ Time Frame: up to 16 days ]
    Examination of abdomen to identify medically significant aberrance

  22. Physical examination [ Time Frame: up to 16 days ]
    Examination of musculoskeletal to identify medically significant aberrance (according to standard of care following the discretion of the treating physician)

  23. Physical examination [ Time Frame: up to 16 days ]
    Examination of skin to identify medically significant aberrance

  24. Physical examination [ Time Frame: up to 16 days ]
    Examination of genitalia to identify medically significant aberrance

  25. Physical examination [ Time Frame: up to 16 days ]
    Examination of neurological system to identify medically significant aberrance (according to standard of care following the discretion of the treating physician)

  26. Red blood cell (RBC) count [ Time Frame: up to 16 days ]
    Laboratory variables

  27. Total white blood cell (WBC) count [ Time Frame: up to 16 days ]
    Laboratory variables

  28. Haemoglobin (Hb) [ Time Frame: up to 16 days ]
    Laboratory variables

  29. Haematocrit (Hct) [ Time Frame: up to 16 days ]
    Laboratory variables

  30. Platelets [ Time Frame: up to 16 days ]
    Laboratory variables

  31. Creatinine [ Time Frame: up to 16 days ]
    Laboratory variables

  32. Urea [ Time Frame: up to 16 days ]
    Laboratory variables

  33. Sodium [ Time Frame: up to 16 days ]
    Laboratory variables

  34. Potassium [ Time Frame: up to 16 days ]
    Laboratory variables

  35. Magnesium [ Time Frame: up to 16 days ]
    Laboratory variables

  36. Total calcium [ Time Frame: up to 16 days ]
    Laboratory variables

  37. Chloride [ Time Frame: up to 16 days ]
    Laboratory variables

  38. Phosphate [ Time Frame: up to 16 days ]
    Laboratory variables

  39. Aspartate aminotransferase (AST) [ Time Frame: up to 16 days ]
    Laboratory variables

  40. Alanine aminotransferase (ALT) [ Time Frame: up to 16 days ]
    Laboratory variables

  41. Alkaline phosphatase (AP) [ Time Frame: up to 16 days ]
    Laboratory variables

  42. Gamma-glutamyl transpeptidase (γ-GT) [ Time Frame: up to 16 days ]
    Laboratory variables

  43. Lactate dehydrogenase (LDH) [ Time Frame: up to 16 days ]
    Laboratory variables

  44. Total and direct bilirubin [ Time Frame: up to 16 days ]
    Laboratory variables

  45. Albumin [ Time Frame: up to 16 days ]
    Laboratory variables

  46. Total protein [ Time Frame: up to 16 days ]
    Laboratory variables

  47. Glucose [ Time Frame: up to 16 days ]
    Laboratory variables

  48. Cholesterol [ Time Frame: up to 16 days ]
    Laboratory variables

  49. Triglycerides [ Time Frame: up to 16 days ]
    Laboratory variables

  50. Low Density Lipoprotein (LDL)-C [ Time Frame: up to 16 days ]
    Laboratory variables

  51. High Density Lipoprotein (HDL)-C [ Time Frame: up to 16 days ]
    Laboratory variables

  52. Fibrinogen [ Time Frame: up to 16 days ]
    Laboratory variables

  53. Activated partial thromboplastin time (APTT) [ Time Frame: up to 16 days ]
    Laboratory variables

  54. Prothrombin time (PT) [ Time Frame: up to 16 days ]
    Laboratory variables

  55. International Normalised Ratio (INR) [ Time Frame: up to 16 days ]
    Laboratory variables

  56. power of hydrogen (pH) value [ Time Frame: up to 16 days ]
    Urine analysis

  57. Bilirubin [ Time Frame: up to 16 days ]
    Urine analysis

  58. Protein [ Time Frame: up to 16 days ]
    Urine analysis

  59. WBC [ Time Frame: up to 16 days ]
    Urine analysis

  60. RBC [ Time Frame: up to 16 days ]
    Urine analysis

  61. Glucose [ Time Frame: up to 16 days ]
    Urine analysis

  62. Ketone body [ Time Frame: up to 16 days ]
    Urine analysis

  63. ECG [ Time Frame: up to 16 days ]
    Electrocardiogram to assess cardiac disorders (e.g. Myocardial infarction, Pericarditis, QT interval Prolongation, etc.)

  64. Preparation time [ Time Frame: 5 days ]
    Comparison of the time required for TPN preparation for the two groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is scheduled to undergo elective abdominal surgery
  2. Female or male patient, age between 18 and 75 years (inclusively)
  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 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. Severe liver insufficiency or AST, ALT 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, 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. Inborn abnormality of amino acid metabolism
  8. Present signs of acute pancreatitis, hypothyroidism or hyper-thyroidism as diagnosed clinically
  9. Serum level of any of the electrolytes (sodium, potassium, magnesium, total calcium, chloride, phosphate) above the upper limit of the normal range
  10. Known unstable metabolism (e.g., known metabolic acidosis)
  11. Known hypersensitivity to fish-, egg-, soybean, or peanut protein or to any of the active substances or excipients of the study drugs
  12. General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency /congestive heart failure
  13. Unstable conditions (e.g., acute myocardial infarction, stroke, embolism, severe sepsis, shock)
  14. Drug abuse and/or chronic alcoholism
  15. Psychiatric diseases, epilepsy
  16. Administration of growth hormones within the previous 4 weeks before surgery, or chronic maintenance therapy with systemic glucocorticoids 4 weeks before surgery
  17. 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
  18. Patient is pregnant or lactating and intends to continue breast-feeding
  19. Development of intraoperative/ postoperative conditions (assessed after surgery and before enrollment of patients):

    1. Intra-operative blood loss > 1000ml;
    2. Development of a condition in which PN is contraindicated;
    3. Intra- or postoperative urine output <0.5 ml/kg/h;
    4. Need for postoperative haemo-filtration or dialysis;
    5. Contraindication or inability to obtain peripheral or central venous catheter access;
    6. Intra-operative decision on limited treatment, e.g. due to diagnosis of carcinomatosis;
    7. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792087


Locations
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China
Beijing Friendship Hospital Capital Medical University
Beijing, China
Peking University People's Hospital
Beijing, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Zhongshan Hospital, Fudan University
Shanghai, China
Sponsors and Collaborators
Fresenius Kabi
Parexel
Investigators
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Principal Investigator: Wu Guohao, MD Fudan University

Additional Information:
Publications:
Helmut Grimm, A balanced lipid emulsion—A new concept in parenteral nutrition. Clinical Nutrition Supplements (2005) 1, 25-30.
Chinese medical clinical guidelines parenteral enteral nutrition 2008, edited by Chinese Medical Association, People's Medical Publishing House.
SSPC. Intralipid 20%, Summary of Product Characteristics, dated 14 February 2007
SSPC. Novamin 11.4%, Summary of Product Characteristics, dated 01 December 2013
Fresenius Kabi. SomfKabiven Peripheral, emulsion for infusion. Summary of Product Characteristics, dated September.29. 2009

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Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT03792087     History of Changes
Other Study ID Numbers: SMKV-011-CP3
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fresenius Kabi:
SmofKabiven
Nutrition
Parenteral
Abdominal surgery