Reaching Protein Target with SmofKabiven® extra Nitrogen Versus Olimel N9E: A Prospective, Randomised, Active-controlled, Patient-blinded, Multicentre Clinical Trial During the Early Phase of Acute Critical Illness

Phase 1

Conditions: Parenteral nutrition (PN) when oral or enteral nutrition (ON or EN) is impossible, insufficient, or contraindicated in the early phase of critical illness
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
MedDRA version: 20.0Level: PTClassification code 10051284Term: Parenteral nutritionSystem Organ Class: 10042613 - Surgical and medical procedures

Registration Number: EUCTR2017-001972-46-DE

Lead Sponsor: Fresenius Kabi Deutschland GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Patients must fulfil all of the following criteria to be eligible for enrolment into the study:
1. Age =18 years and <90 years, male and female
2. Critically ill, medical or surgical ICU patient
3. Admitted to the ICU during the previous 24 hours with a minimum expected ICU stay of =3 days
4. Central venous access is available for continuous infusion of the study drugs
5. SOFA score =2
6. Contraindication against EN or limited tolerance to EN and it is planned that patient receives =80% of the total target caloric intake from PN during the first 3 nutritional treatment days
7. Written informed consent from the patient or the patient’s legal representative or deferred written consent from the patient or patient’s legal representative (deferred proxy consent)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Medical Exclusions
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 and/or non-nutritional sources (e.g. glucose solution for drug dilution or lipids from propofol) during the first 3 nutritional treatment days
4. BMI <18.5 kg/m2 or >35 kg/m2 5. Burn injury
6. Any severe, persistent blood coagulation disorder with uncontrolled 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 Fibre
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 <0.5 mL/kg/h/ for =12 hours (Acute Kidney Injury stage =2; (KDIGO 2012)), and BUN exceeding 2 x ULN
13. Severe liver failure with encephalopathy, including intoxication (e.g. paracetamol, death cap, golden chain) and/or liver enzymes (AST, ALT, GGT) or bilirubin exceeding 5 x ULN
14. Oncologic disease under current anticancer treatment
15. Preceding transplantation causal for acute critical illness
16. Hemophagocytic syndrome
17. Pregnancy or lactation
18. Receiving end-of-life care
Laboratory Exclusions (assessed by local laboratory at study site):
19. Pathologically altered blood pH (arterial pH <7.0), oxygen saturation (SpO2 <80%), or carbon dioxide concentration (PaCO2 =80 mm Hg)
20. Hyperlipidaemia or any disorder of lipid metabolism characterised by
hypertriglyceridemia (serum triglyceride levels >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)
Concomitant Therapy Exclusions:
22. Administration of growth hormone including teduglutide within the previous 4 weeks before randomisation
Other Exclusions:
23. Participation in another interventional clinical trial within the previous 4 weeks before randomization
24. Previous inclusion in the present study
25. Any other known reason that may prevent a patient to take part in the study in accordance with local requirements

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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: <br>• Proportion of patients reaching =70% of the cumulative target for protein delivery from Study Day 2 through Study Day 6<br>- 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<br>- The cumulative protein delivery is calculated as the cumulative intake of amino acids from study drug and protein from EN on Study Day 2 through 6<br>;Timepoint(s) of evaluation of this end point: Protein intake during the 5-day treatment period: from Study Day 2 to Day 6<br>

Secondary Outcome Measures

Name	Time	Method

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