Efficacy and security of glutamine dipeptide (Dipeptiven®) - Supplemented parenteral nutrition in critic patients.Double blind, randomized, multicenter study. - FREDI

Phase 1

• Conditions: Critic patient that require parenteral nutrition

• Registration Number: EUCTR2004-001805-90-ES
• Lead Sponsor: Fresenius Kabi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-07
• Study Completion: 2007-05-25
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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

• Malnutrition or obesity (BMI < 18.5 or >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 < 2 days.
• Hypertriglyceridemy (TG > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>Nosocomial infection diagnosis will be establish according to CDC criteria.