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

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 on the same day or the day before 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

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 <18.5 kg/m2 or >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 <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 with anticancer drug and/or radiation treatment
incl. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) during this
trial up to and including study day 28
15. Preceding transplantation causal for acute critical illness
16. Hemophagocytic syndrome
17. Pregnancy or lactation
18. Receiving end-of-life care
19. Pathologically altered blood pH (arterial pH <7.0), oxygen saturation (SaO2 <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)
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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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