Efficacy and Safety of SmofKabiven Peripheral Versus Compounded Emulsion

NCT03792087 | Completed Phase 3

• 1 other identifier: SMKV-011-CP3
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 5

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.

Conditions

Parenteral Feeding; Surgery

Keywords

SmofKabiven; Nutrition; Parenteral; Abdominal surgery

Outcome Measures

Primary Outcomes (1)

• Serum Prealbumin

  Change in Serum Prealbumin

  6 days

Secondary Outcomes (13)

• C-reactive Protein (CRP)

  6 days

• Linoleic acid

  6 days

• Linolenic acid

  6 days

• Arachidonic acid

  6 days

• Eicosapentaenoic acid (EPA)

  6 days

Other Outcomes (48)

• Adverse Events (AE)

  up to 16 days

• Local intolerance for peripherally infusion

  6 days

• Development of phlebitis

  6 days

Study Arms (2)

SmofKabiven Peripheral

EXPERIMENTAL

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

Hospital compounded emulsion

ACTIVE COMPARATOR

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

Interventions

SmofKabiven Peripheral DRUG

Total Parenteral Nutrition

Also known as: Study intervention, Investigational Product

SmofKabiven Peripheral

Hospital compounded emulsion DRUG

Total Parenteral Nutrition

Also known as: Control, Comparator

Hospital compounded emulsion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is scheduled to undergo elective abdominal surgery
• Female or male patient, age between 18 and 75 years (inclusively)
• Postoperatively, patient is expected to receive 100% of the total daily energy demand via PN for at least 5 consecutive days
• Body Mass Index (BMI) ≥ 16 and ≤ 30 kg /m2, and actual body weight ≥ 40 kg
• Patient is capable to give Informed Consent, agrees to participate in the study, and signs the Informed Consent Form

You may not qualify if:

• Patient has received PN or parenteral amino acids in the last 10 days before randomization (exception: administration of glucose will be allowed)
• Severe liver insufficiency or AST, ALT or total bilirubin at least 1.5-times higher than the upper limit of normal range
• International Normalised Ratio (INR) at least 1.5 times higher than the upper limit of normal range
• Uncontrolled hyperglycaemia, fasting blood glucose \> 180 mg/ dl (10 mmol/L)
• Severe renal impairment defined as serum creatinine value at least 1.5 times higher than the upper limit of normal range
• 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)
• Inborn abnormality of amino acid metabolism
• Present signs of acute pancreatitis, hypothyroidism or hyper-thyroidism as diagnosed clinically
• Serum level of any of the electrolytes (sodium, potassium, magnesium, total calcium, chloride, phosphate) above the upper limit of the normal range
• Known unstable metabolism (e.g., known metabolic acidosis)
• Known hypersensitivity to fish-, egg-, soybean, or peanut protein or to any of the active substances or excipients of the study drugs
• General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency /congestive heart failure
• Unstable conditions (e.g., acute myocardial infarction, stroke, embolism, severe sepsis, shock)
• Drug abuse and/or chronic alcoholism
• Psychiatric diseases, epilepsy

Sponsors & Collaborators

• Fresenius Kabi: lead
• Parexel: collaborator

Study Sites (5)

Beijing Friendship Hospital Capital Medical University

Beijing, China

Location

Peking University People's Hospital

Beijing, China

Location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, China

Location

Zhongshan Hospital, Fudan University

Shanghai, China

Location

Related Publications (25)

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  BACKGROUND

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  BACKGROUND

Study Officials

• Wu Guohao, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: January 3, 2019
• Study Start: December 21, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

CN (5)