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

NCT03992716 | Terminated Phase 4

• 2 other identifiers: SKNt-001-CP42017-001972-46
• Study Type: interventional
• Target: 7
• Locations: 3 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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 over 5 Study Days (based on a daily target of 0.75 g/kg/day on Study Day 2 and 1.5 g/kg/day on Study Days 3 through 6); 70% of the cumulative target for protein delivery is 4.73 g/kg. The cumulative protein delivery is calculated as the cumulative intake of amino acids from study drug and protein from enteral or oral nutrition on Study Day 2 through Study Day 6.

  5 days

Secondary Outcomes (3)

• Percentage of the cumulative target for protein delivery reached from Study Day 2 through Study Day 6

  5 days

• Mean cumulative protein delivery by parenteral, enteral, and oral nutrition from Study Day 2 through Study Day 6

  5 days

• Calculated mean cumulative protein deficit during the period from Study Day 2 through Study Day 6

  5 days

Other Outcomes (23)

• Mean total cumulative energy intake from parenteral, enteral and oral nutrition and from non-nutritional sources during the 5-day treatment period (calculated for each day from Study Day 2 through Study Day 6)

  5 days

• Time to increase of daily enteral and oral nutrition intake above 20% of total energy target of 20 kcal/kg/d during the 5-day treatment period

  5 days

• Mean daily insulin dose during the 5-day treatment period

  5 days

Study Arms (2)

SmofKabiven® extra Nitrogen

EXPERIMENTAL

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.

Drug: SmofKabiven® extra Nitrogen

Olimel N9E

ACTIVE COMPARATOR

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.

Drug: Olimel N9E

Interventions

SmofKabiven® extra Nitrogen 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.

SmofKabiven® extra Nitrogen

Olimel N9E 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.

Olimel N9E

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and \<90 years, male and female
• Critically ill, medical or surgical ICU patient
• Admitted to the ICU on the same day or the day before with a minimum expected ICU stay of 3 days
• Central venous access available for continuous infusion of the study drugs
• Sequential Organ Failure Assessment (SOFA) score ≥2
• 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
• 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)

You may not qualify if:

• Contraindication against parenteral nutrition or inability to receive parenteral nutrition via central venous access
• Received parenteral nutrition within 7 days before randomisation
• 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
• Body mass index (BMI) \<18.5 kg/m2 or \>35 kg/m2
• Burn injury
• 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 substances or excipients contained in SmofKabiven® extra Nitrogen or Olimel N9E
• Known hypersensitivity to milk protein or to any other substance contained in Fresubin® Original
• 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
• 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)
• 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
• Oncologic disease with anticancer drug and/or radiation treatment incl. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) during this Trial up to and including Study Day 28
• Preceding transplantation causal for acute critical illness

Sponsors & Collaborators

• Fresenius Kabi: lead

Study Sites (3)

Hôpital Saint-Antoine, Département d'Anesthésie-Réanimation

Paris, 75012, France

Location

Klinikum rechts der Isar, Klinik für Anaesthesiologie

München, 81675, Germany

Location

SP ZOZ Wojewódzki Szpital Zespolony im. J. Śniadeckiego

Bialystok, 15-897, Poland

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julien Bohe, Prof. MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 20, 2019
• Study Start: November 26, 2019
• Primary Completion: March 24, 2020
• Study Completion: March 24, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); DE (1); PL (1)