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

Primary Purpose

Nutrition Therapy, Critical Illness

Status

Active

Phase

Phase 3

Locations

Russian Federation

Study Type

Interventional

Intervention

SmofKabiven extra Nitrogen

About this trial

This is an interventional supportive care trial for Nutrition Therapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Municipal Clinical Hospital No. 40 of Moscow Healthcare Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SmofKabiven extra Nitrogen

Arm Description

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.

Outcomes

Primary Outcome Measures

Protein intake during the study treatment period

Percentage of patients who have reached ≥ 70% of the cumulative target protein intake.

Secondary Outcome Measures

Percentage of the cumulative target protein intake reached over the study treatment period

Mean daily protein intake from parenteral nutrition (PN), enteral nutrition (EN), oral nutrition (ON), oral nutrition supplements (ONS) over the study treatment period

Cumulative protein intake from PN, EN, ON, ONS over the study treatment period

Mean daily caloric intake from PN, EN, ON, ONS, and non-nutritional sources over the study treatment period

Cumulative caloric intake from PN, EN, ON, ONS, and non-nutritional sources over the study treatment period

Full Information

NCT ID

NCT05257031

First Posted

January 31, 2022

Last Updated

September 30, 2022

Sponsor

Fresenius Kabi

1. Study Identification

Unique Protocol Identification Number

NCT05257031

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 12, 2022 (Actual)

Primary Completion Date

September 11, 2022 (Actual)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fresenius Kabi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nutrition Therapy, Critical Illness

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SmofKabiven extra Nitrogen

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

SmofKabiven extra Nitrogen

Intervention Description

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.

Primary Outcome Measure Information:

Title

Protein intake during the study treatment period

Description

Percentage of patients who have reached ≥ 70% of the cumulative target protein intake.

Time Frame

Study Days 1 to 5

Secondary Outcome Measure Information:

Title

Percentage of the cumulative target protein intake reached over the study treatment period

Time Frame

Study Days 1 to 5

Title

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

Title

Cumulative protein intake from PN, EN, ON, ONS over the study treatment period

Time Frame

Study Days 1 to 5

Title

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

Title

Cumulative caloric intake from PN, EN, ON, ONS, and non-nutritional sources over the study treatment period

Time Frame

Study Days 1 to 5

Other Pre-specified Outcome Measures:

Title

Incidence of adverse events

Time Frame

Until 24 hours after the end of last infusion

Title

Incidence of serious adverse events

Time Frame

Until 24 hours after the end of last infusion

Title

Changes in vital signs (blood pressure)

Time Frame

Study Days 1 to 6

Title

Changes in vital signs (heart rate)

Time Frame

Study Days 1 to 6

Title

Changes in vital signs (respiratory rate)

Time Frame

Study Days 1 to 6

Title

Changes in vital signs (body temperature)

Time Frame

Study Days 1 to 6

Title

Adverse events of special interest: hyperglycaemia, hypoglycaemia, hypertriglyceridemia

Time Frame

Until 24 hours after the end of last infusion

Title

Changes in laboratory variables (number of patients with abnormal values)

Time Frame

Study Days 4 and 6

Title

Incidence of (serious) adverse events

Time Frame

24 hours after the end of the last infusion up to Study Day 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Denis N Protsenko, MD

Organizational Affiliation

Municipal Clinical Hospital No. 40 of Moscow Healthcare Department

Official's Role

Principal Investigator

Facility Information:

Facility Name

Municipal Clinical Hospital No. 40 of Moscow Healthcare Department

City

Moscow

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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