Efficacy and Safety of SmofKabiven Extra Nitrogen for Parenteral Nutrition in Patients Receiving Intensive Care

February 20, 2024 updated by: Fresenius Kabi

An Open-label, Non-Comparative, Multicentre Trial to Assess the Efficacy and Safety of SmofKabiven Extra Nitrogen for Parenteral Nutrition in Patients Receiving Intensive Care

The aim of this clinical trial is to assess the efficacy and safety of the investigational product SmofKabiven extra Nitrogen in patients requiring parenteral nutrition (PN) to achieve the target protein dose. The cumulative target protein dose is 6.2 g per kg of body weight (BW) over the five study treatment days, with 1.0 g/kg BW on Study Day 1 and 1.3 g/kg BW per day on Study Days 2-5; the target caloric intake is 15 kcal/kg BW on Study Day 1 and 20 kcal/kg BW/day on Study Days 2-5, following the recommendation of the ESPEN guideline on clinical nutrition in the intensive care unit 2019 regarding a slow-ramp up of calories during the first week of critical illness.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Moscow, Russian Federation
        • Municipal Clinical Hospital No. 40 of Moscow Healthcare Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years and < 90 years, male or female
  • Critically ill, medical or surgical intensive care unit (ICU) patient
  • The patient was admitted to the ICU during the previous 24-48 hours and has a minimum expected ICU stay of 5 days after the completion of screening
  • Central venous access available for continuous infusion of the investigational product
  • Contraindication against EN or limited tolerance to EN; it is planned that the patient receives ≥75% of the total target caloric intake from PN during the 5 investigational product treatment days
  • Informed consent (signed and dated) from the patient to participate in this clinical trial. If the patient is unable to make a decision because of his/her critical condition, a decision regarding study enrolment is made at a case conference involving three physicians

Exclusion Criteria:

  • Contraindication against PN or inability to receive PN via central venous access
  • The patient has received PN within the last 7 days before the start of screening
  • Body mass index (BMI) <18.5 kg/m2 or >35 kg/m2
  • Any severe, persistent blood coagulation disorder with uncontrolled bleeding
  • Any congenital errors of amino acid metabolism
  • Uncontrolled hyperglycaemia despite insulin treatment
  • Known hypersensitivity to fish, egg, soybean proteins, peanut proteins, or to any of the active ingredients or excipients contained in SmofKabiven extra Nitrogen
  • General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency
  • Severe renal insufficiency defined by the following criteria:

    • serum creatinine level > 353.6 µmol/L, or
    • creatinine level ≥ 3.0 times higher than the upper limit of normal (according to the KDIGO 2012 Clinical Practice Guideline), or
    • diuresis < 0.3 mL/kg/hr during ≥ 12 hrs (Acute Kidney Injury stage ≥ 3 according to the KDIGO 2012 Clinical Practice Guideline) without access to renal replacement therapy
  • Unstable haemodynamic conditions (e.g., acute myocardial infarction, stroke, embolism, severe sepsis, shock) including acute shock (arterial serum lactate > 2.0 mmol/L)
  • Severe liver insufficiency
  • Haemophagocytic syndrome
  • Pregnancy or lactation
  • Receiving end-of-life care
  • Severe hyperlipidaemia (serum cholesterol and/or triglycerides and/or LDL-C level at least 1.5 times higher than the upper limit of normal range)
  • Pathologically elevated serum levels of any of the included electrolytes (sodium, potassium, magnesium, total calcium, chloride, inorganic phosphate)
  • Participation in another interventional clinical trial within the previous 4 weeks
  • Previous inclusion in the present study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SmofKabiven extra Nitrogen

The investigational product will be administered in a volume that provides the target caloric intake of 15 kcal/kg BW on Study Day 1 and 20 kcal/kg BW/day on Study Days 2 to 5.

If calories are provided from other sources (e.g., enteral/oral nutrition/oral nutritional supplements or non-nutritional sources including glucose solution for drug dilution or propofol), the dose of the investigational product will be reduced accordingly to avoid calorie overload above the respective daily caloric targets.

SmofKabiven extra Nitrogen contains amino acids (Aminoven®), glucose, lipids (SMOFlipid®: 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, 15% fish oil), and electrolytes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protein intake during the study treatment period
Time Frame: Study Days 1 to 5
Percentage of patients who have reached ≥ 70% of the cumulative target protein intake.
Study Days 1 to 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of the cumulative target protein intake reached over the study treatment period
Time Frame: Study Days 1 to 5
Study Days 1 to 5
Mean daily protein intake from parenteral nutrition (PN), enteral nutrition (EN), oral nutrition (ON), oral nutrition supplements (ONS) over the study treatment period
Time Frame: Study Days 1 to 5
Study Days 1 to 5
Cumulative protein intake from PN, EN, ON, ONS over the study treatment period
Time Frame: Study Days 1 to 5
Study Days 1 to 5
Mean daily caloric intake from PN, EN, ON, ONS, and non-nutritional sources over the study treatment period
Time Frame: Study Days 1 to 5
Study Days 1 to 5
Cumulative caloric intake from PN, EN, ON, ONS, and non-nutritional sources over the study treatment period
Time Frame: Study Days 1 to 5
Study Days 1 to 5

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: Until 24 hours after the end of last infusion
Until 24 hours after the end of last infusion
Incidence of serious adverse events
Time Frame: Until 24 hours after the end of last infusion
Until 24 hours after the end of last infusion
Changes in vital signs (blood pressure)
Time Frame: Study Days 1 to 6
Study Days 1 to 6
Changes in vital signs (heart rate)
Time Frame: Study Days 1 to 6
Study Days 1 to 6
Changes in vital signs (respiratory rate)
Time Frame: Study Days 1 to 6
Study Days 1 to 6
Changes in vital signs (body temperature)
Time Frame: Study Days 1 to 6
Study Days 1 to 6
Adverse events of special interest: hyperglycaemia, hypoglycaemia, hypertriglyceridemia
Time Frame: Until 24 hours after the end of last infusion
Until 24 hours after the end of last infusion
Changes in laboratory variables (number of patients with abnormal values)
Time Frame: Study Days 4 and 6
Study Days 4 and 6
Incidence of (serious) adverse events
Time Frame: 24 hours after the end of the last infusion up to Study Day 12
24 hours after the end of the last infusion up to Study Day 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Denis N Protsenko, MD, Municipal Clinical Hospital No. 40 of Moscow Healthcare Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2022

Primary Completion (Actual)

September 11, 2022

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

January 31, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • SKNt-002-CP3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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