Parenteral nutrition (PN) when oral or enteral nutrition (ON or EN) is impossible, insufficient, or contraindicated in the early phase of critical illness MedDRA version: 21.1 Level: PT Classification code 10051284 Term: Parenteral nutrition System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
Fresenius Kabi Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must fulfil all of the following criteria to be eligible for enrolment into the study: 1. Age =18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Contraindication against PN or inability to receive PN via central venous access 2. Received PN within 7 days before randomisation 3. It is planned that patient receives =20% of the total target caloric intake via EN, ON (including ONS) and/or non-nutritional sources (glucose solution for drug dilution or lipids from propofol/clevidipine or citrate from CRRT) during the first 3 nutritional treatment days 4. BMI 35 kg/m2 5. Burn injury 6. Any severe, persistent blood coagulation disorder with unIt is planned that patient receives =20% of the total target caloric intake via EN, ON (including ONS) and/or non-nutritional sources (glucose solution for drug dilution or lipids from propofol/clevidipine or citrate from CRRT) during the first 3 nutritional treatment dayscontrolled bleeding 7. Any congenital errors of amino acid metabolism 8. Uncontrolled hyperglycaemia despite insulin treatment 9. Known hypersensitivity to fish, egg, soybean proteins, peanut protein, or to any of the active substances or excipients contained in SmofKabiven® extra Nitrogen or Olimel N9E 10. Known hypersensitivity to milk protein or to any other substance contained in Fresubin® Original 11. Treatment-refractory cardiopulmonary or metabolic instability showing persistent or progressive worsening despite increased interventions, including severe pulmonary oedema, severe cardiac insufficiency, myocardial infarction, acute phase of circulatory shock, severe sepsis, embolism, haemodynamic instability, metabolic or respiratory acidosis, hypotonic dehydration, or hyperosmolar coma 12. Severe renal dysfunction, defined as serum creatinine =2.0 times baseline or urine output 4 mmol/L [>350 mg/dL]) 21. Treatment-refractory, clinically significant major abnormality in the serum concentration of any electrolyte (sodium, potassium, magnesium, total calcium, chloride, inorganic phosphorous) 22. Administration of growth hormone including teduglutide within the previous 4 weeks before randomization 23. Invasive devices and procedures influencing metabolism and organ perfusion, e.g. extracorporeal membrane oxygenation (ECMO), CRRT, molecular absorbent recycling system (MARS), intra-aortic balloon pump (IABP) 24. Receipt of the last dose of study drug in another interventional clinical trial within the previous 4 weeks before randomisation into this clinical trial 25. Previous inclusion in the present study 26. Any other known reason that may prevent a patient to take part in the study in accordance with local requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the efficacy of SmofKabiven extra Nitrogen compared with Olimel N9E in reducing the cumulative protein deficit with the same caloric target during the early phase of acute critical illness in haemodynamically stable adult patients who require PN;Secondary Objective: N/A;Primary end point(s): Protein intake during the 5-day treatment period: • Proportion of patients reaching =70% of the cumulative target for protein delivery from Study Day 2 through Study Day 6 - The cumulative target for protein delivery is 6.75 g/kg/5d (based on a daily target of 0.75 g/kg on Study Day 2 and 1.5 g/kg/d on Study Days 3 through 6); 70% of the cumulative target for protein delivery = 4.73 g/kg/5d - The cumulative protein delivery is calculated as the cumulative intake of amino acids from study drug and protein from EN or ON (including ONS) on Study Day 2 through 6;Timepoint(s) of evaluation of this end point: Protein intake during the 5-day treatment period: from Study Day 2 to Day 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Protein intake during the 5-day treatment period: • Percentage of the cumulative target for protein delivery reached from Study Day 2 through Study Day 6 - Actual cumulative protein delivery (g/kg/5d) divided by 6.75 (g/kg/5d) multiplied by 100 • Mean cumulative protein delivery by PN, EN and ON (including ONS) from Study Day 2 through Study Day 6 • Calculated mean cumulative protein deficit during the period from Study Day 2 through Study Day 6 - The cumulative protein deficit is calculated as the cumulative target for protein delivery (6.75 g/kg/5d) minus the actual administered dose (g/kg/5d amino acids from study drug + g/kg/5d protein from EN and ON (including ONS)) Energy intake during the 5-day treatment period: • Mean total cumulative energy intake from PN, EN, ON (including ONS) and non-nutritional sources during the 5-day treatment period (calculated for each day from Study Day 2 through Study Day 6) • Time to increase of daily EN and ON (including ONS) intake above 20% of total energy target of 20 kcal/kg/d during the 5-day treatment period Insulin dose during the 5-day treatment period: • Mean daily insulin dose during the 5-day treatment period • Mean cumulative insulin dose for the 5-day treatment period • Mean change from baseline in daily insulin dose (Study Day 2 through Study Day 6) • Maximum single insulin dose during the 5-day treatment period Blood glucose profile during the 5-day treatment period: • Mean maximum daily blood glucose value during the 5-day treatment period • Mean minimum daily blood glucose value during the 5-day treatment period • Mean blood glucose value during the 5-day treatment period • Mean change from baseline in mean daily blood glucose value (Study Day 2 through Study Day 6) Clinical outcome parameters (up to Study Day 28): • Change from baseline in SOFA score, calculated daily from Study Day 3 through Study Day 7 • Overall survival time up to Study Day 28 • Al | — |
Countries
France, Germany, Poland
Contacts
Public ContactDivisional Medical Clinical Affairs
Fresenius Kabi Deutschland GmbH
Outcome results
None listed