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

• ClinicalTrials.gov Identifier: NCT05257031
• Recruitment Status: Active, not recruiting
• First Posted: February 25, 2022
• Last Update Posted: October 3, 2022
• Sponsor: Fresenius Kabi
• Information provided by (Responsible Party): Fresenius Kabi

Tracking Information

• First Submitted Date: January 31, 2022
• First Posted Date: February 25, 2022
• Last Update Posted Date: October 3, 2022
• Actual Study Start Date: February 12, 2022
• Actual Primary Completion Date: September 11, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 16, 2022)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 16, 2022)

• Percentage of the cumulative target protein intake reached over the study treatment period [ Time Frame: 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 ]
• Cumulative protein intake from PN, EN, ON, ONS over the study treatment period [ Time Frame: 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 ]
• Cumulative caloric intake from PN, EN, ON, ONS, and non-nutritional sources over the study treatment period [ Time Frame: Study Days 1 to 5 ]

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: February 16, 2022)

• Incidence of adverse events [ Time Frame: 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 ]
• Changes in vital signs (blood pressure) [ Time Frame: Study Days 1 to 6 ]
• Changes in vital signs (heart rate) [ Time Frame: Study Days 1 to 6 ]
• Changes in vital signs (respiratory rate) [ Time Frame: Study Days 1 to 6 ]
• Changes in vital signs (body temperature) [ Time Frame: Study Days 1 to 6 ]
• Adverse events of special interest: hyperglycaemia, hypoglycaemia, hypertriglyceridemia [ Time Frame: 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 ]
• Incidence of (serious) adverse events [ Time Frame: 24 hours after the end of the last infusion up to Study Day 12 ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Efficacy and Safety of SmofKabiven Extra Nitrogen for Parenteral Nutrition in Patients Receiving Intensive Care
• Official Title: 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Nutrition Therapy
• Critical Illness

Intervention

Drug: SmofKabiven extra Nitrogen

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.

Study Arms

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.

Intervention: Drug: SmofKabiven extra Nitrogen

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 16, 2022): 56
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2023
• Actual Primary Completion Date: September 11, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Russian Federation

Administrative Information

• NCT Number: NCT05257031
• Other Study ID Numbers: SKNt-002-CP3
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Fresenius Kabi
• Original Responsible Party: Same as current
• Current Study Sponsor: Fresenius Kabi
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Fresenius Kabi
• Verification Date: September 2022