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

Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03792100
• Other study ID #: SMKV-015-CP3
• Status: Completed
• Phase: Phase 3
• Start date: January 3, 2019
• Est. completion date: January 23, 2020

Study information

• Verified date: July 2021
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: January 23, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parenteral Nutrition
• Surgery

Intervention

Drug:
• SmofKabiven emulsion for infusion
Total Parenteral Nutrition
• Hospital compounded "All in one" emulsion
Total Parenteral Nutrition

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing
China	The Second Hospital of Jilin University	Changchun
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Thepeople's hospital of Guangxi zhuang	Nanning
China	Shanghai First People's hospital	Shanghai
China	Shanghai Pudong Hospital	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai
China	Shanxi Provincial People's Hospital	Taiyuan

Sponsors (2)

Lead Sponsor	Collaborator
Fresenius Kabi	Parexel

Country where clinical trial is conducted

China, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events (AE)	Coded according to Medical Dictionary for Regulatory Affairs (MedDRA) by System Organ Class (SOC) and preferred term	up to 16 days
Other	Blood pressure	Vital signs	up to 16 days
Other	Heart rate	Vital signs	up to 16 days
Other	Respiratory rate	Vital signs	up to 16 days
Other	Axillary body temperature	Vital signs	up to 16 days
Other	Physical examination	Examination of abnormal findings in any system/organ	up to 16 days
Other	Red blood cell (RBC) count	Laboratory variable	up to 16 days
Other	Total white blood cell (WBC) count	Laboratory variable	up to 16 days
Other	Haemoglobin (Hb)	Laboratory variable	up to 16 days
Other	Haematocrit (Hct)	Laboratory variable	up to 16 days
Other	Platelets	Laboratory variable	up to 16 days
Other	Creatinine	Laboratory variable	up to 16 days
Other	Urea	Laboratory variable	up to 16 days
Other	Sodium	Laboratory variable	up to 16 days
Other	Potassium	Laboratory variable	up to 16 days
Other	Magnesium	Laboratory variable	up to 16 days
Other	Total calcium	Laboratory variable	up to 16 days
Other	Chloride	Laboratory variable	up to 16 days
Other	Phosphate	Laboratory variable	up to 16 days
Other	Aspartate aminotransferase (AST)	Laboratory variable	up to 16 days
Other	Alanine aminotransferase (ALT)	Laboratory variable	up to 16 days
Other	Alkaline phosphatase (AP)	Laboratory variable	up to 16 days
Other	Gamma-glutamyl transpeptidase (?-GT)	Laboratory variable	up to 16 days
Other	Lactate dehydrogenase (LDH)	Laboratory variable	up to 16 days
Other	Total and direct bilirubin	Laboratory variable	up to 16 days
Other	Albumin	Laboratory variable	up to 16 days
Other	Total protein	Laboratory variable	up to 16 days
Other	Glucose	Laboratory variable	up to 16 days
Other	Cholesterol	Laboratory variable	up to 16 days
Other	Triglycerides	Laboratory variable	up to 16 days
Other	Low Density Lipoprotein (LDL)-C	Laboratory variable	up to 16 days
Other	High Density Lipoprotein (HDL)-C	Laboratory variable	up to 16 days
Other	Fibrinogen	Laboratory variable	up to 16 days
Other	Activated partial thromboplastin time (APTT)	Laboratory variable	up to 16 days
Other	Prothrombin time (PT)	Laboratory variable	up to 16 days
Other	International Normalised Ratio (INR)	Laboratory variable	up to 16 days
Other	Power of water (pH) value	Urine analysis	up to 16 days
Other	Bilirubin	Urine analysis	up to 16 days
Other	Protein	Urine analysis	up to 16 days
Other	White Blood Cell (WBC)	Urine analysis	up to 16 days
Other	Red Blood Cell (RBC)	Urine analysis	up to 16 days
Other	Urine Glucose	Urine analysis	up to 16 days
Other	Ketone body	Urine analysis	up to 16 days
Other	Electrocardiogram (ECG)	Electrocardiogram to assess cardiac disorders (e.g. Myocardial infarction, Pericarditis, QT interval Prolongation, etc.)	up to 16 days
Primary	Serum Prealbumin	Change in Serum Prealbumin	6 days
Secondary	Nosocomial infection	Postsurgical new onset of nosocomial infection	6 days
Secondary	Prealbumin	Change in Prealbumin	4 days
Secondary	C-reactive Protein (CRP)	Change in CRP	6 days
Secondary	Linoleic acid	Change in linoleic acid	6 days
Secondary	Linolenic acid	Change in linolenic acid	6 days
Secondary	Arachidonic acid	Change in arachidonic acid	6 days
Secondary	Eicosapentaenoic acid (EPA)	Change in EPA	6 days
Secondary	Docosahexaenoic acis (DHA)	Change in DHA	6 days
Secondary	Thromboxane B3 (TX B3) / Thromboxane B2 (TX B2)	Change in TX B3/B2	6 days
Secondary	Interleukin (IL)-1	Change in IL-1	6 days
Secondary	Interleukin (IL)-2	Change in IL-2	6 days
Secondary	Interleukin (IL)-6	Change in IL-6	6 days
Secondary	Cluster of Differentiation 4 (CD4) / Cluster of Differentiation 8 (CD8)	Change in CD4/CD8	6 days
Secondary	Plasma amino acid (taurine)	Change in taurine	6 days

External Links

•   International Council for Harmonisation (ICH) E10 'Note for Guidance on Choice of Control Group', July 2000