E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Enfermedad pulmonar obstructiva crónica y síndrome de obesidad ventilación |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009725 |
E.1.2 | Term | EPOC |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064205 |
E.1.2 | Term | Síndrome de obesidad-hipoventilación |
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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 |
Evaluar el efecto del tratamiento de la alcalosis metabólica con acetazolamida sobre la evolución de pacientes con EPOC o con SOH conectados a VM invasiva por una insuficiencia respiratoria aguda. |
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E.2.2 | Secondary objectives of the trial |
1- Determinar si el tratamiento con acetazolamida en pacientes con EPOC o con SOH intubados por una insuficiencia respiratoria aguda y que presentan AM disminuye los días de VM respecto a los pacientes tratados con placebo. 2- Determinar si la administración de acetazolamida disminuye la estancia y la mortalidad en UCI y en el hospital en estos pacientes. 3- Evaluar los efectos secundarios derivados del tratamiento con acetazolamida. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Pacientes de más de 18 años con EPOC o SOH con insuficiencia respiratoria aguda que han precisado intubación y conexión a VM dentro de los últimos tres días y que presenten AM definida como pH superior a 7,35 y bicarbonato actual superior a 28 mmol/L estando en VM, con niveles de potasio plasmáticos iguales o superiores a 4 mEq/L (podrán corregirse los niveles de potasio plasmático en caso de ser < 4 mEq/L y reevaluar al paciente para su inclusión). |
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E.4 | Principal exclusion criteria |
Pacientes de tipo quirúrgico o con enfermedades psiquiátricas, epilepsia, embarazo, cirrosis hepática, intolerancia o alergia a acetazolamida u otros agentes basados en sulfonamidas, valores de creatinina plasmática > 2,5 mg/dL o clearance de creatinina < 20 mL/min o requerimientos de técnicas dialíticas, intolerancia a la vía enteral, que hayan recibido bicarbonato sódico o acetazolamida en las últimas 72 h o que sean enfermos terminales. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Duración de ventilación mecánica y duración de tiempo weaning, índice f/Vt, valores iónicos en plasma, parámetros de ventilación mecánica, estancia en UCI del hospital, mortalidad, gasometrías. |
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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 | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
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
|
Cuando finalice el reclutamiento y seguimiento de 156 pacientes |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |