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

NCT03792100 | Completed Phase 3

• 1 other identifier: SMKV-015-CP3
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 8

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.

Conditions

Parenteral Nutrition; Surgery

Keywords

SmofKabiven; Abdominal surgery; Parenteral; Nutrition

Outcome Measures

Primary Outcomes (1)

• Serum Prealbumin

  Change in Serum Prealbumin

  6 days

Secondary Outcomes (14)

• Nosocomial infection

  6 days

• Prealbumin

  4 days

• C-reactive Protein (CRP)

  6 days

• Linoleic acid

  6 days

• Linolenic acid

  6 days

Other Outcomes (44)

• Adverse Events (AE)

  up to 16 days

• Blood pressure

  up to 16 days

• Heart rate

  up to 16 days

Study Arms (2)

SmofKabiven emulsion for infusion

EXPERIMENTAL

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

Hospital compounded "All in one" emulsion for PN

ACTIVE COMPARATOR

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

Interventions

SmofKabiven emulsion for infusion DRUG

Total Parenteral Nutrition

Also known as: Study intervention, Investigational Product

SmofKabiven emulsion for infusion

Hospital compounded "All in one" emulsion DRUG

Total Parenteral Nutrition

Also known as: Control, Comparator

Hospital compounded "All in one" emulsion for PN

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is scheduled to undergo elective gastrointestinal surgery;
• Female or male patients, age ≥ 18 and ≤ 80 years;
• 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 kg/m2 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);
• 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;
• International Normalised Ratio (INR) at least 1.5 times higher than the upper limit of normal range;
• Uncontrolled hyperglycaemia defined as 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);
• Known inborn abnormality of amino acid metabolism in the medical history;
• Known acute pancreatitis in the medical history;
• Known hypothyroidism or hyperthyroidism in the medical history;
• 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 in the medical history (e.g., metabolic acidosis);
• 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;
• General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency /congestive heart failure;
• Unstable haemodynamic conditions (e.g., acute myocardial infarction, stroke, embolism, severe sepsis, shock);
• Known hemophagocytic syndrome;

Sponsors & Collaborators

• Fresenius Kabi: lead
• Parexel: collaborator

Study Sites (8)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

The Second Hospital of Jilin University

Changchun, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

Thepeople's hospital of Guangxi zhuang

Nanning, China

Location

Shanghai First People's hospital

Shanghai, China

Location

Shanghai Pudong Hospital

Shanghai, China

Location

Zhongshan Hospital Fudan University

Shanghai, China

Location

Shanxi Provincial People's Hospital

Taiyuan, China

Location

Related Publications (29)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhang Zhongtao, MD

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Allocation to the treatment arms will not be known to the patient
• 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: January 3, 2019
• Primary Completion: January 23, 2020
• Study Completion: January 23, 2020
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)