EUCTR2004-001805-90-ES进行中（未招募）1 期
Efficacy and security of glutamine dipeptide (Dipeptiven®) - Supplemented parenteral nutrition in critic patients.Double blind, randomized, multicenter study. - FREDI
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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