Reaching Protein Target With SmofKabiven® Extra Nitrogen vs Olimel N9E During the Early Phase of Acute Critical Illness

NCT ID: NCT03992716

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-26
• Study Completion Date: 2020-03-24

Brief Summary

The main focus of the study is to show that SmofKabiven® extra Nitrogen, in a realistic clinical setting, enables to meet high protein requirements in patients during the first week after onset of critical illness, without risk of overfeeding with energy.

Conditions

Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

SmofKabiven® extra Nitrogen

Parenteral nutrition with SmofKabiven® extra Nitrogen in a dosage to provide 10 kcal/kg/day on Study Day 2 and 20 kcal/kg/day on Study Days 3 through 6.

Group Type: EXPERIMENTAL

SmofKabiven® extra Nitrogen

Intervention Type: DRUG

SmofKabiven® extra Nitrogen (Fresenius Kabi) is a sterile, hypertonic emulsion for parenteral nutrition, in a 3-chamber bag containing amino acids, glucose, a lipid emulsion, and electrolytes.

Olimel N9E

Parenteral nutrition with Olimel N9E in a dosage to provide 10 kcal/kg/day on Study Day 2 and 20 kcal/kg/day on Study Days 3 through 6.

Group Type: ACTIVE_COMPARATOR

Olimel N9E

Intervention Type: DRUG

Olimel N9E (Baxter) is a sterile, hypertonic emulsion for parenteral nutrition, in a 3-chamber bag containing amino acids, glucose, a lipid emulsion, and electrolytes.

Interventions

SmofKabiven® extra Nitrogen

SmofKabiven® extra Nitrogen (Fresenius Kabi) is a sterile, hypertonic emulsion for parenteral nutrition, in a 3-chamber bag containing amino acids, glucose, a lipid emulsion, and electrolytes.

Intervention Type: DRUG

Olimel N9E

Olimel N9E (Baxter) is a sterile, hypertonic emulsion for parenteral nutrition, in a 3-chamber bag containing amino acids, glucose, a lipid emulsion, and electrolytes.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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 available for continuous infusion of the study drugs

5. Sequential Organ Failure Assessment (SOFA) score ≥2

6. Contraindication against enteral nutrition or limited tolerance to enteral nutrition and it is planned that patient receives ≥80% of the total target caloric intake from parenteral nutrition 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)

Exclusion Criteria

1. Contraindication against parenteral nutrition or inability to receive parenteral nutrition via central venous access

2. Received parenteral nutrition within 7 days before randomisation

3. It is planned that patient receives ≥20% of the total target caloric intake via enteral or oral nutrition and/or non-nutritional sources (glucose solution for drug dilution or lipids from propofol/clevidipine or citrate from continuous renal replacement therapy) during the first 3 nutritional treatment days

4. Body mass index (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 proteins, 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 blood urea nitrogen (BUN) exceeding 2 x upper limit of normal (ULN)

13. Severe liver failure with encephalopathy, including intoxication (e.g. paracetamol, death cap, golden chain) and/or liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma glutamyl transferase [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 hypertriglyceridaemia (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 phosphate)

22. Administration of growth hormone including teduglutide within the previous 4 weeks before randomisation

23. Invasive devices and procedures influencing metabolism and organ perfusion, e.g. extracorporeal membrane oxygenation (ECMO), continuous renal replacement therapy (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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Kabi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julien Bohe, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Département d'Anesthésie-Réanimation, Centre Hospitalier Lyon Sud, France

Locations

Hôpital Saint-Antoine, Département d'Anesthésie-Réanimation

Paris, , France

Klinikum rechts der Isar, Klinik für Anaesthesiologie

München, , Germany

SP ZOZ Wojewódzki Szpital Zespolony im. J. Śniadeckiego

Bialystok, , Poland

Countries

France; Germany; Poland

Other Identifiers

2017-001972-46

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SKNt-001-CP4

Identifier Type: -

Identifier Source: org_study_id