Nutrition TherapyPhase 3NCT05257031
Efficacy and Safety of SmofKabiven Extra Nitrogen for Parenteral Nutrition in Patients Receiving Intensive Care
A Phase 3 study testing SmofKabiven extra Nitrogen in people with Nutrition Therapy and Critical Illness, run by Fresenius Kabi at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nutrition Therapy, Critical Illness
- What is being tested?
- SmofKabiven extra Nitrogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteRussia
- Study dates
- 12 Feb 2022to 30 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Municipal Clinical Hospital No. 40 of Moscow Healthcare Department
Moscow
About this study
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
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.
- Conditions
- Nutrition Therapy, Critical Illness
- Being tested
- SmofKabiven extra Nitrogen
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmofKabiven extra NitrogenDrug
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 group | Role | What they receive |
|---|---|---|
| SmofKabiven extra Nitrogen | Experimental | 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. Receives: Drug: SmofKabiven extra Nitrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein intake during the study treatment period
Percentage of patients who have reached ≥ 70% of the cumulative target protein intake.
Measured: Study Days 1 to 5
Secondary outcomes (5)
Percentage of the cumulative target protein intake reached over the study treatment period
Measured: 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
Measured: Study Days 1 to 5
Cumulative protein intake from PN, EN, ON, ONS over the study treatment period
Measured: Study Days 1 to 5
Mean daily caloric intake from PN, EN, ON, ONS, and non-nutritional sources over the study treatment period
Measured: Study Days 1 to 5
Cumulative caloric intake from PN, EN, ON, ONS, and non-nutritional sources over the study treatment period
Measured: Study Days 1 to 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start12 Feb 2022
- Primary completion11 Sep 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Denis N Protsenko, MD, Principal investigator, Municipal Clinical Hospital No. 40 of Moscow Healthcare Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257031
- Sponsor's protocol ID
- SKNt-002-CP3
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2022
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05257031
- Acronym / sponsor ID
- SKNt-002-CP3
- Conditions
- Nutrition Therapy, Critical Illness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2022 (actual)
- Primary completion
- 11 Sep 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SmofKabiven extra Nitrogen | Experimental | Drug: SmofKabiven extra NitrogenThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmofKabiven extra NitrogenSmofKabiven extra Nitrogen contains amino acids (Aminoven®), glucose, lipids (SMOFlipid®: 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, 15% fish oil), and electrolytes. | Drug | SmofKabiven extra Nitrogen |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis N Protsenko, MD principal investigator
Municipal Clinical Hospital No. 40 of Moscow Healthcare Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SmofKabiven extra Nitrogen in people with Nutrition Therapy and Critical Illness, run by Fresenius Kabi at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein intake during the study treatment period (time frame: Study Days 1 to 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.