The population studied will be the elderly population at risk for malnutrition without any predefined pathology at hospital geriatrician wards. MedDRA version: 9.1 Level: PT Classification code 10051284 Term: Parenteral nutrition
Conditions
Interventions
Product Name: Clinimix N9G15E 1 litre
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: L-alanine
Concentration unit: g/l gram(s)/litre
Sponsors
Baxter R and D Europe SCRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both genders 2. Age superior or equal to 65 years 3. Hospitalized and at risk for malnutrition defined by their MNA SF below 12 and GNRI between 83.5 and 97.5. 4. Oral intake =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Malnutrition requiring tube feeding or parenteral nutrition when admitted to study. Parenteral nutrition includes use of glucose 10% or greater and amino acid solutions 2. Severe cardiac failure or serious cardiovascular compromise 3.Patients receiving therapeutic anticoagulation 4. Patients with coagulopathies (platelet count 1.5 normal) 5. Severe burns or other diffuse skin diseases on site of the the infusion administration 6. Patient with decubitus ulcers greater than grade 2 (NPUAP classification) 7. Patient with an inflammatory syndrome defined by a CRP >50 mg/L 8. Severe Renal failure 9. Known hypersensitivity to components of Clinimix N9G15E 10. Unconsciousness 11. Not expected to survive for a minimum of 3 weeks 12. Known congenital abnormalities of amino acid metabolism 13. Severe uncontrolled hyperglycemia 14. Severe electrolyte disorders precluding administration of Na, K, Ca, Mg, PO4 15. Patients taking part already in this study 16. Patients taking part in any other clinical trials within 2 months 17. Patients who have received Clinimix N9G15E or any other amino acid solution within the 10 previous days by any administration routes 18. Confined persons and prisoners 19. Patients with any other clinically significant disease or clinically significant finding, which, at the discretion of the investigator, would expose the patient to an increased risk of a significant adverse event or would interfere with the assessments of efficacy or safety during the course of the study 20.Patients with a history of or physical examination findings indicative of active alcohol or drug abuse 21. Known HIV positivity 22. Patients without affiliation to the French "Sécurité Sociale"
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show the non-inferiority of subcutaneously versus intravenously administered Clinimix N9G15E 1 L, upon major local side effects defined as large edema, blistering, phlebitis, cellulitis, erythema (diameter > 10 cm) and strong pain.;Secondary Objective: To assess the safety and the efficacy of Clinimix N9G15E administered subcutaneously versus intravenously upon patient nutritional parameters, clinical outcomes and hydration status.;Primary end point(s): Major local side effects defined as large edema (diameter > 10 cm), blistering(diameter > 2 cm), erythema (diameter > 10 cm), phlebitis, cellulitis, and strong pain. | — |
Countries
France
Outcome results
None listed