- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05257031
Efficacy and Safety of SmofKabiven Extra Nitrogen for Parenteral Nutrition in Patients Receiving Intensive Care
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Moscow, Russian Federation
- Municipal Clinical Hospital No. 40 of Moscow Healthcare Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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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
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Percentage of patients who have reached ≥ 70% of the cumulative target protein intake.
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Study Days 1 to 5
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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
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Study Days 1 to 5
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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
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Study Days 1 to 5
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Cumulative protein intake from PN, EN, ON, ONS over the study treatment period
Time Frame: Study Days 1 to 5
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Study Days 1 to 5
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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
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Study Days 1 to 5
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Cumulative caloric intake from PN, EN, ON, ONS, and non-nutritional sources over the study treatment period
Time Frame: Study Days 1 to 5
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Study Days 1 to 5
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events
Time Frame: Until 24 hours after the end of last infusion
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Until 24 hours after the end of last infusion
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Incidence of serious adverse events
Time Frame: Until 24 hours after the end of last infusion
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Until 24 hours after the end of last infusion
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Changes in vital signs (blood pressure)
Time Frame: Study Days 1 to 6
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Study Days 1 to 6
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Changes in vital signs (heart rate)
Time Frame: Study Days 1 to 6
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Study Days 1 to 6
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Changes in vital signs (respiratory rate)
Time Frame: Study Days 1 to 6
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Study Days 1 to 6
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Changes in vital signs (body temperature)
Time Frame: Study Days 1 to 6
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Study Days 1 to 6
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Adverse events of special interest: hyperglycaemia, hypoglycaemia, hypertriglyceridemia
Time Frame: Until 24 hours after the end of last infusion
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Until 24 hours after the end of last infusion
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Changes in laboratory variables (number of patients with abnormal values)
Time Frame: Study Days 4 and 6
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Study Days 4 and 6
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Incidence of (serious) adverse events
Time Frame: 24 hours after the end of the last infusion up to Study Day 12
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24 hours after the end of the last infusion up to Study Day 12
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Denis N Protsenko, MD, Municipal Clinical Hospital No. 40 of Moscow Healthcare Department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SKNt-002-CP3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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