E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
MODULACIÓN DE LA RESPUESTA INFLAMATORIA SISTÉMICA EN NIÑOS CRÍTICAMENTE ENFERMOS TRAS LA SUPLEMENTACIÓN CON GLUTAMINA MODULATION OF THE SYSTEMIC INFLAMMATORY RESPONSE IN CRITICAL ILL CHILDREN AFTER GLUTAMINE SUPPLEMENTATION |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
determinar si existen diferencias en la respuesta inflamatoria de los pacientes suplementados con glutamina respecto a los que reciben nutrición estándar sin glutamina |
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E.2.2 | Secondary objectives of the trial |
se valorará la respuesta clínica en los dos grupos de pacientes respecto la aparición de infecciones, de fallo multiorgánico, estancia media en la unidad y mortalidad |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Pacientes entre 1 mes y 14 años que requieran nutrición parenteral según los criterios de nuestra unidad y que cumplan uno de los siguientes diagnósticos i. Infección sistémica o local. ii. Postcirugia abdominal. iii. Pacientes politraumatizados.
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E.4 | Principal exclusion criteria |
iv. No consentimiento del tutor. v. Pacientes con enfermedades de base previas (insuficiencia renal, insuficiencia hepática, enfermedad inflamatoria intestinal, enfermedades reumáticas, enfermedades metabólicas, inmunocomprometidos). vi. Disfunción hepática leve al ingreso (hepatitis, colostasis…) vii. Post operados de cirugia cardíaca extracorporea. viii. Pacientes derivados de otros centros con evolución clínica superior a 48 horas. ix. Pacientes menores de un mes de vida y mayores de 14 años.
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E.5 End points |
E.5.1 | Primary end point(s) |
La variable principal de estudio es determinar si existen diferencias en la respuesta inflamatoria de los pacientes suplementados con glutamina respecto a los que reciben nutrición estándar sin glutamina. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
alimentación parenteral standard |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |