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Trial record 58 of 359 for:    transthyretin

Efficacy and Safety of SmofKabiven Emulsion for Infusion Versus Hospital Compounded Emulsion "All in One" for Parenteral Nutrition

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ClinicalTrials.gov Identifier: NCT03792100
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : May 8, 2019
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Fresenius Kabi

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. 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).

Condition or disease Intervention/treatment Phase
Parenteral Nutrition Surgery Drug: SmofKabiven emulsion for infusion Drug: Hospital compounded "All in one" emulsion Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 272 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 and Safety of SmofKabiven Emulsion for Infusion [Multi-oil Fat Emulsion (C6-24)/Amino Acids (16)/Glucose (42%) and Electrolyte Injection] Versus Hospital Compounded Emulsion "All in One" for Parenteral Nutrition: A Randomized, Active-Controlled, Patient-blinded, Multi-Centre Study in Adult Surgical Patients Requiring Parenteral Nutrition
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


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

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




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


Secondary Outcome Measures :
  1. Nosocomial infection [ Time Frame: 6 days ]
    Postsurgical new onset of nosocomial infection

  2. Prealbumin [ Time Frame: 4 days ]
    Change in Prealbumin

  3. C-reactive Protein (CRP) [ Time Frame: 6 days ]
    Change in CRP

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

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

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

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

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

  9. Thromboxane B3 (TX B3) / Thromboxane B2 (TX B2) [ Time Frame: 6 days ]
    Change in TX B3/B2

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

  11. Interleukin (IL)-2 [ Time Frame: 6 days ]
    Change in IL-2

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

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

  14. Plasma amino acid (taurine) [ Time Frame: 6 days ]
    Change in 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. Blood pressure [ Time Frame: up to 16 days ]
    Vital signs

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

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

  5. Axillary body temperature [ Time Frame: up to 16 days ]
    Vital signs

  6. Physical examination [ Time Frame: up to 16 days ]
    Examination of the head to detect significant medical aberrance

  7. Physical examination [ Time Frame: up to 16 days ]
    Examination of mouth to detect significant medical aberrance

  8. Physical examination [ Time Frame: up to 16 days ]
    Examination of the nose to detect significant medical aberrance

  9. Physical examination [ Time Frame: up to 16 days ]
    Examination of the throat to detect significant medical aberrance

  10. Physical examination [ Time Frame: up to 16 days ]
    Examination of the tonsils to detect significant medical aberrance

  11. Physical examination [ Time Frame: up to 16 days ]
    Examination of the eyes to detect significant medical aberrance (according to standard of care following the discretion of the treating physician)

  12. Physical examination [ Time Frame: up to 16 days ]
    Examination of the neck to detect significant medical aberrance

  13. Physical examination [ Time Frame: up to 16 days ]
    Examination of the lungs and chest to detect significant medical aberrance

  14. Physical examination [ Time Frame: up to 16 days ]
    Examination of the breasts to detect significant medical aberrance

  15. Physical examination [ Time Frame: up to 16 days ]
    Examination of the cardiovascular system to detect significant medical aberrance (according to standard of care following the discretion of the treating physician)

  16. Physical examination [ Time Frame: up to 16 days ]
    Examination of the abdomen to detect significant medical aberrance

  17. Physical examination [ Time Frame: up to 16 days ]
    Examination of the genitalia to detect significant medical aberrance

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

  19. Physical examination [ Time Frame: up to 16 days ]
    Examination of the skin to detect significant medical aberrance

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

  21. Physical examination [ Time Frame: up to 16 days ]
    Examination of the lymph nodes to detect significant medical aberrance

  22. Physical examination [ Time Frame: up to 16 days ]
    Examination of the ears to detect significant medical aberrance,

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

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

  25. Haemoglobin (Hb) [ Time Frame: up to 16 days ]
    Laboratory variable

  26. Haematocrit (Hct) [ Time Frame: up to 16 days ]
    Laboratory variable

  27. Platelets [ Time Frame: up to 16 days ]
    Laboratory variable

  28. Creatinine [ Time Frame: up to 16 days ]
    Laboratory variable

  29. Urea [ Time Frame: up to 16 days ]
    Laboratory variable

  30. Sodium [ Time Frame: up to 16 days ]
    Laboratory variable

  31. Potassium [ Time Frame: up to 16 days ]
    Laboratory variable

  32. Magnesium [ Time Frame: up to 16 days ]
    Laboratory variable

  33. Total calcium [ Time Frame: up to 16 days ]
    Laboratory variable

  34. Chloride [ Time Frame: up to 16 days ]
    Laboratory variable

  35. Phosphate [ Time Frame: up to 16 days ]
    Laboratory variable

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

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

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

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

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

  41. Total and direct bilirubin [ Time Frame: up to 16 days ]
    Laboratory variable

  42. Albumin [ Time Frame: up to 16 days ]
    Laboratory variable

  43. Total protein [ Time Frame: up to 16 days ]
    Laboratory variable

  44. Glucose [ Time Frame: up to 16 days ]
    Laboratory variable

  45. Cholesterol [ Time Frame: up to 16 days ]
    Laboratory variable

  46. Triglycerides [ Time Frame: up to 16 days ]
    Laboratory variable

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

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

  49. Fibrinogen [ Time Frame: up to 16 days ]
    Laboratory variable

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

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

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

  53. Power of water (pH) value [ Time Frame: up to 16 days ]
    Urine analysis

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

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

  56. White Blood Cell (WBC) [ Time Frame: up to 16 days ]
    Urine analysis

  57. Red Blood Cell (RBC) [ Time Frame: up to 16 days ]
    Urine analysis

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

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

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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):

    1. Intra-operative blood loss > 1000 ml;
    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 haemofiltration or dialysis;
    5. Contraindication or inability to obtain 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): NCT03792100


Contacts
Layout table for location contacts
Contact: Miao Yu, MD +86-10-59096956 miao.yu@fresenius-kabi.com
Contact: Lu Weibj +86-10-59096901 weibj.lu@fresenius-kabi.com

Locations
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China
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, China
The Second Hospital of Jilin University Recruiting
Changchun, China
The First Affiliated Hospital of Guangzhou Medical University Not yet recruiting
Guangzhou, China
Thepeople's hospital of Guangxi zhuang Recruiting
Nanning, China
Shanghai First People's hospital Not yet recruiting
Shanghai, China
Shanghai Pudong Hospital Not yet recruiting
Shanghai, China
Zhongshan Hospital Fudan University Not yet recruiting
Shanghai, China
The First Affiliated Hospital of Soochow University Not yet recruiting
Suzhou, China
Shanxi Provincial People's Hospital Not yet recruiting
Taiyuan, China
Sponsors and Collaborators
Fresenius Kabi
Parexel
Investigators
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Principal Investigator: Zhang Zhongtao, MD Beijing Friendship Hospital

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.
Fresenius Kabi SSPC. Intralipid 20%, Summary of Product Characteristics, dated 14 February 2007.
Fresenius Kabi SSPC. Novamin 11.4%, Summary of Product Characteristics, dated 01 December 2013.
Fresenius Kabi. SomfKabiven emulsion for infusion. Summary of Product Characteristics, dated December 08. 2008.
ZHAO Subin, GU Junxia, ZHANG Xianbin, SHI Dongfang, Early enteral nutrition with Fresubin after gastrointestinal operation, Parenteral& Enteral Nutrition, Ju1.2003, Vol l0 No.3: 134-136.
Wei Yi Fa (2001) No.2: Notice for Ministry of Health of China to Publish the Diagnosis Criteria of Nosocomial Infection (Pilot Edition). Ministry of Health of China Office, Jan.2, 200.

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Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT03792100     History of Changes
Other Study ID Numbers: SMKV-015-CP3
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Abdominal surgery
Parenteral
Nutrition