Critic patient that require parenteral nutrition
Conditions
Interventions
Product Name: Glutamine dipeptide for supplemet pareteral nutrition
Pharmaceutical Form: Intravenous infusion
Product Name: Aminoaccids solution
Pharmaceutical Form: Intravenous infusion
Sponsors
Fresenius Kabi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female adults over 18 years old. • Patients admited in intensive care units. • APACHE II score over 12. • Total parenteral nutrition from 5 to 9 days requeriment and with presenceof contraindication for enteral nutrition or with probed intolerance to enteral food during 48 hours. • Writed Informed consent, or given by a close related person if it is possible. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Malnutrition or obesity (BMI 33). • Unstable hemodynamic situation (persitent shock, uncontroled haemorrhage, post-cardiorespiratory stop). • Chronic renal failure that require dialysis. • Acute renal failure no treated with hemofiltration (creatinine >= 250 µmol/l). • Hepatic failure with encephalopathy. • Portal hypertension. • Severe metabolic acidose. • Known hyersensitivity to any component of the preparation. • Other previous endocrine upsets (aminoacids metabolism disease). • Patients with life expectancy 3 Normality Top Limit). • Familiar hyperlipidemy (Familiar Hypercholesterolemy, Type IIb, IIIa, IV and V hyperlipoproteinemy ). • Continous infusion of propofol. • Contraindication for central catheter. • Maintenance therapy with systemic steroids (> 0.3 mg kg-1 d-1). • Patients with compromised immune function such as: o Patiens with signs and symptoms of AIDS classified as B and C category. o Patients constituent of immunosupression o Drugs induced neutropeny • Women lactating or pregnant. • Psyquiatric state that prevent the patient to unserstand the nature, scope and possible consequences of the study, or no cooperative attitude. • To be taking part in other study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and security of the supplementation with l-alanyl-L-glutamine (Ala-Gln) in critic patients with a high APACHE II score (>12), and with presence of a contraindication for enteral nutrition or with probed intolerance to enteral food during 48 hours, that riquire total parenteral nutrition from 5 to 9 days.;Secondary Objective: ;Primary end point(s): • Incidence of the clinic complication: deffinied in this study as nosocomial infection during the stay in ICU. Nosocomial infection diagnosis will be establish according to CDC criteria. | — |
Countries
Spain
Outcome results
None listed