E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
BURNT-INDUCED SINUSAL TACHYCARDIA |
TAQUICARDIA SINUSAL INDUCIDA POR LA QUEMADURA |
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E.1.1.1 | Medical condition in easily understood language |
BURNT-INDUCED SINUSAL TACHYCARDIA |
TAQUICARDIA SINUSAL INDUCIDA POR LA QUEMADURA |
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E.1.1.2 | Therapeutic area | Diseases [C] - Injuries, poisonings, and occupational diseases [C21] |
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 |
Assess the effect of treatment with propranolol in the adult burnt patient with sinusal tachycardia by measuring its effect on the resting energy expenditure. |
Comprobar el efecto del tratamiento con propranolol en el paciente quemado adulto intubado con taquicardia sinusal mediante la medición de la magnitud de la disminución del gasto energético |
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E.2.2 | Secondary objectives of the trial |
o Assess the effect of the treatment of sinusal tachycardia with propranolol in the morbidity and mortality of the burned patient (sepsis, infections, necessity of inotropic agents, burn wound colonization).
o Assess the effect of the treatment of sinusal tachycardia with propranolol on wound healing (graft intake and donor sites´ epithelialization).
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• Valorar el efecto de la disminución de la administración de propranolol para el tratamiento de la taquicardia sinusal del paciente quemado intubado sobre su morbi-mortalidad (sepsis, infecciones, necesidad de soporte inotrópico, colonización de quemaduras).
• Valorar el efecto de la administración de propranolol para el tratamiento de la taquicardia sinusal del paciente quemado intubado sobre su cicatrización (prendimiento de injertos y epitelización de zonas donantes de injertos).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Burnt patients with mechanical ventilation, between 14 and 75 years of age, with sinusal tachycardia (>100 bpm), admitted to our Burns Unit during an estimated period of 2 years. |
Pacientes quemados mayores de 14 años y menores de 75 años con taquicardia sinusal (>100 latidos por minuto) y necesidad de ventilación mecánica invasiva, ingresados en nuestra Unidad durante un periodo estimado de 2 años. |
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E.4 | Principal exclusion criteria |
Patients in whom beta-blockers are contraindicated.
Patients with beta-blocker treatment before admission.
Unsigned Informed Consent
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Se excluyen del estudio aquellos pacientes en los que esté contraindicada la administración de beta-bloqueantes y aquellos que ya estaban beta-bloqueados antes del ingreso.
Consentimiento Informado no firmado |
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E.5 End points |
E.5.1 | Primary end point(s) |
Resting energy expenditure and respiratory quotient (VCO2/VO2) |
Gasto energético en reposo y cociente respiratorio (VCO2/VO2 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1.At the time of admission
2. Daily until 2 weeks post injury |
1. Al ingreso
2. Diarios hasta completar 2 semanas post lesion. |
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E.5.2 | Secondary end point(s) |
-HR and BP
-Caloric intake
-Need of sedoanalgesia
-Inotropic agents
-Days of inotropic agents administration
-Number of surgical procedures needed
-Healing time for donor sites
-Graft intake 5 days after surgery
-Burn wound colonization
-Burn wound infection or donor site infection
-Other infections
-Sepsis
-Mortality
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-Frecuencia cardíaca y TA diarias:
-Aportes calóricos totales
-Sedoanalgesia
-Necesidad de inotrópicos
-Días necesarios de inotrópicos
-Intervenciones quirúrgicas
-Tiempo de cicatrización de las heridas (zonas donantes)
-Porcentaje de prendimiento de injertos a los 5 días de la cirugía
-Colonización de quemaduras
-Infección de quemaduras o zonas donantes
-Otras infecciones
-Sepsis
-Mortalidad
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.At the time of admission
2. Daily until 2 weeks post injury |
1. Al ingreso
2. Diarios hasta completar 2 semanas post lesion. |
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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 | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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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LVLS |
Ultima visita del ultimo paciente |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |