RESUMEN
OBJECTIVE: To assess the efficacy and safety of a treatment with clopidogrel when associated or not to the treatment with tirofiban and aspirin for high-risk non-ST segment elevation myocardial infarction (non-STEMI), without early angioplasty. SETTING: Intensive Care and Coronary Unit (ICCU), in a center with no Hemodynamic Laboratory. DESIGN: Non randomized clinical trial. PARTICIPANTS: One hundred and twenty-three patients admitted with the diagnosis of high-risk non-STEMI, defined as patients with chest pain and one of the following: ST segment depression or transient elevation or an elevation in cardiac troponin I (TropIc). INTERVENTIONS: We included patients admitted in a 24-month period. During the first 12-month period, the patients received tirofiban and clopidogrel (group A). In the second one, clopidogrel was not administered (group B). Urgent cardiac catheterism was requested if recurrent ischemic chest pain with ST segment changes, left ventricular failure or hemodynamic instability were present. PRIMARY VARIABLES: A composite of recurrent ischemic chest pain with ST segment changes or death during ICCU admission was evaluated as an efficacy variable. A variable of safety was defined as the occurrence of intracranial or gastrointestinal bleeding, or any hemorrhagic event accompanied by a drop of at least 3 g/dl of hemoglobin. The rate of urgent cardiac catheterisms was recorded. RESULTS: Neither the rate of the efficacy variable (19.6 % in group A and 19.4% in group B; p = 0.97), nor the rate of the safety variable (3.5% and 2.9% of patients in groups A and B, p = 1) showed statistically significant difference. There was no statistically significant difference in the rate of urgent cardiac catheterism (19.6% in group A and 13.4% in group B; p = 0.35). CONCLUSIONS: In the early course of high-risk non-STEMI with a conservative management strategy, the addition of clopidogrel to tirofiban does not change the rate of ischemic events, death, need of urgent catheterism or hemorrhagic events.
Asunto(s)
Aspirina/uso terapéutico , Infarto del Miocardio/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Ticlopidina/análogos & derivados , Tirosina/análogos & derivados , Anciano , Clopidogrel , Electrocardiografía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/fisiopatología , Ticlopidina/uso terapéutico , Tirofibán , Tirosina/uso terapéuticoRESUMEN
Objetivo. Valorar la eficacia y seguridad del tratamiento con clopidogrel cuando se asocia o no al tratamiento con tirofibán más ácido acetilsalicílico (AAS) en el síndrome coronario agudo sin elevación persistente del segmento ST (SCASEST) de alto riesgo, sin intervencionismo precoz. Ámbito. Unidad de Cuidados Intensivos (UCI), en centro sin laboratorio de hemodinámica. Diseño. Ensayo clínico sin asignación aleatoria. Pacientes. Ciento veintitrés pacientes con SCASEST de alto riesgo, definido como dolor torácico y uno de los siguientes: descenso del segmento ST o ascenso transitorio o aumento de troponina I cardíaca (TropIc). Intervenciones. Estudio desarrollado durante veinticuatro meses. Los primeros doce meses el tratamiento incluía tirofibán y clopidogrel (grupo A); en los siguientes doce meses, el clopidogrel no se administraba (grupo B). El cateterismo cardíaco urgente se solicitó si aparecía dolor torácico recurrente con cambios en el segmento ST, fallo ventricular izquierdo o inestabilidad hemodinámica. Variables principales. Se evaluó una variable de eficacia, formada por la combinación de la aparición de dolor torácico con cambios en el segmento ST o muerte durante la estancia en la UCI, y una variable de seguridad, definida por la existencia de hemorragias intracraneales, digestivas o aquellas asociadas a una disminución de hemoglobina de al menos 3 g/dl. Se registró la frecuencia de realización de cateterismo urgente. Resultados. No hubo diferencias estadísticas significativas en la frecuencia de la variable de eficacia (19,6% en el grupo A y 19,4% en el grupo B; p = 0,97), ni en la de seguridad (3,5 y 2,9% en los grupos A y B respectivamente; p = 1). Tampoco existió diferencia estadística significativa en la realización de cateterismo urgente (19,6% en el grupo A y 13,4% en el grupo B; p = 0,35). Conclusiones. En el curso inicial del SCASEST de alto riesgo con una estrategia de tratamiento conservadora, la adición de clopidogrel al tirofibán no modifica la aparición de eventos isquémicos, muerte o necesidad de cateterismo urgente, ni se asocia a un incremento de complicaciones hemorrágicas
Objective. To assess the efficacy and safety of a treatment with clopidogrel when associated or not to the treatment with tirofiban and aspirin for high-risk non-ST segment elevation myocardial infarction (non-STEMI), without early angioplasty. Setting. Intensive Care and Coronary Unit (ICCU), in a center with no Hemodynamic Laboratory. Design. Non randomized clinical trial. Participants. One hundred and twenty-three patients admitted with the diagnosis of high-risk non-STEMI, defined as patients with chest pain and one of the following: ST segment depression or transient elevation or an elevation in cardiac troponin I (TropIc). Interventions. We included patients admitted in a 24-month period. During the first 12-month period, the patients received tirofiban and clopidogrel (group A). In the second one, clopidogrel was not administered (group B). Urgent cardiac catheterism was requested if recurrent ischemic chest pain with ST segment changes, left ventricular failure or hemodynamic instability were present. Primary variables. A composite of recurrent ischemic chest pain with ST segment changes or death during ICCU admission was evaluated as an efficacy variable. A variable of safety was defined as the occurrence of intracranial or gastrointestinal bleeding, or any hemorrhagic event accompanied by a drop of at least 3 g/dl of hemoglobin. The rate of urgent cardiac catheterisms was recorded. Results. Neither the rate of the efficacy variable (19.6 % in group A and 19.4% in group B; p = 0.97), nor the rate of the safety variable (3.5% and 2.9% of patients in groups A and B, p = 1) showed statistically significant difference. There was no statistically significant difference in the rate of urgent cardiac catheterism (19.6% in group A and 13.4% in group B; p = 0.35). Conclusions. In the early course of high-risk non-STEMI with a conservative management strategy, the addition of clopidogrel to tirofiban does not change the rate of ischemic events, death, need of urgent catheterism or hemorrhagic events
Asunto(s)
Humanos , Enfermedad Coronaria/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/farmacocinética , Enfermedad Coronaria/fisiopatología , Cuidados Críticos/métodos , Isquemia Miocárdica/fisiopatologíaRESUMEN
OBJECTIVE: Describe the use of remifentanil in definitive pacemaker implant. DESIGN: Prospective, observational study. SCOPE: Intensive Care Unit of two general hospitals. PATIENTS: Ninety-four patients subjected to DPM implant under sedation with remifentanil. INTERVENTIONS: The protocol for DPM implant was conducted: premedication with metoclopramide, remifentanil perfusion (20 micro g/ml), local infiltration with mepivacaine 2%, administration of magnesium metamizole at the end of the implant and posterior discontinuation of remifentanil. Remifentanil perfusion was initiated at 2 micro g/minute, increasing it until reaching a sedation grade 2-3 on the Ramsay scale, with a maximum of 6 micro g/minute. MAIN ENDPOINTS: Time needed to reach the desired sedation grade and duration of sedation, maximum dose of remifentanil necessary, frequency that another sedation was needed and of adverse events were recorded. Continuous quantitative endpoints were expressed as mean +/- SD. RESULTS: A sedation grade 2-3 was achieved with a perfusion rhythm of 3.6 +/- 1.4 micro g/min, in 20 +/- 22 minutes. In 89 patients (94.6%), the implant was performed only with remifentanil. Frequency of adverse events were nauseas/vomiting 21.3%, hypotension 5.3% and respiratory depression 1%. Remifentanil perfusion was discontinued in 3 patients (3.2%) due to appearance of adverse events. Another sedoanalgesic was used in 2 patients (2.1%). CONCLUSIONS: Remifentanil is useful in the implant of DPM as a sedoanalgesia method. Serious undesired effects are rare. Future studies are necessary to completely establish its effectiveness and safety in these types of procedures.
Asunto(s)
Anestésicos Intravenosos/administración & dosificación , Sedación Consciente/métodos , Piperidinas/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Anestésicos Intravenosos/efectos adversos , Estimulación Cardíaca Artificial , Procedimientos Quirúrgicos Cardíacos/métodos , Sedación Consciente/efectos adversos , Femenino , Humanos , Infusiones Intravenosas , Masculino , Persona de Mediana Edad , Marcapaso Artificial , Piperidinas/efectos adversos , Estudios Prospectivos , RemifentaniloRESUMEN
Objetivo. Describir el empleo de remifentanilo en el implante de marcapasos definitivo. Diseño. Estudio prospectivo observacional. Ámbito. Unidad de Cuidados Intensivos de dos hospitales generales. Pacientes. Noventa y cuatro pacientes sometidos a implante de marcapasos definitivo (MPD) bajo sedación con remifentanilo. Intervenciones. Se llevó a cabo el protocolo para implantación de MPD: premedicación con metoclopramida, perfusión de remifentanilo (20 µg/ml), infiltración local con mepivacaína 2%, administración de metamizol magnésico al terminar el implante y suspensión posterior de remifentanilo. La perfusión de remifentanilo se inició con 2 µg/minuto, incrementándola hasta alcanzar un grado de sedación 2-3 en la escala de Ramsay, con un máximo de 6 µg/minuto. Variables principales. Se registraron los tiempos transcurridos en alcanzar el grado de sedación deseado y de permanencia de la sedación, la dosis máxima necesaria de remifentanilo, la frecuencia con la que se necesitó otra sedación y la de efectos adversos. Las variables cuantitativas continuas se expresaron como media ± desviación estándar (DE). Resultados. Un grado de sedación 2-3 se consiguió con un ritmo de perfusión de 3,6 ± 1,4 µg/minuto, en 20 ± 22 minutos. En 89 pacientes (94,6%) el implante se llevó a cabo con remifentanilo exclusivamente. La frecuencia de efectos adversos fueron náuseas/vómitos 21,3%, hipotensión 5,3% y depresión respiratoria 1%. La perfusión de remifentanilo fue suspendida en 3 pacientes (3,2%) por la aparición de efectos adversos. Se empleó otra sedoanalgesia en 2 pacientes (2,1%). Conclusiones. El remifentanilo es útil en el implante de MPD como método de sedoanalgesia. Los efectos indeseables graves son poco frecuentes. Son necesarios futuros estudios para establecer completamente su efectividad y seguridad en este tipo de procedimientos
Objective. Describe the use of remifentanil in definitive pacemaker implant. Design. Prospective, observational study. Scope. Intensive Care Unit of two general hospitals. Patients. Ninety-four patients subjected to DPM implant under sedation with remifentanil. Interventions. The protocol for DPM implant was conducted: premedication with metoclopramide, remifentanil perfusion (20 µg/ml), local infiltration with mepivacaine 2%, administration of magnesium metamizole at the end of the implant and posterior discontinuation of remifentanil. Remifentanil perfusion was initiated at 2 µg/minute, increasing it until reaching a sedation grade 2-3 on the Ramsay scale, with a maximum of 6 µg/minute. Main endpoints. Time needed to reach the desired sedation grade and duration of sedation, maximum dose of remifentanil necessary, frequency that another sedation was needed and of adverse events were recorded. Continuous quantitative endpoints were expressed as mean ± SD. Results. A sedation grade 2-3 was achieved with a perfusion rhythm of 3.6 ± 1.4 µg/min, in 20 ± 22 minutes. In 89 patients (94.6%), the implant was performed only with remifentanil. Frequency of adverse events were nauseas/vomiting 21.3%, hypotension 5.3% and respiratory depression 1%. Remifentanil perfusion was discontinued in 3 patients (3.2%) due to appearance of adverse events. Another sedoanalgesic was used in 2 patients (2.1%). Conclusions. Remifentanil is useful in the implant of DPM as a sedoanalgesia method. Serious undesired effects are rare. Future studies are necessary to completely establish its effectiveness and safety in these types of procedures
Asunto(s)
Masculino , Femenino , Adulto , Persona de Mediana Edad , Anciano , Humanos , Narcóticos/uso terapéutico , Marcapaso Artificial , Analgesia/métodos , Estudios Prospectivos , Protocolos Clínicos , Narcóticos/efectos adversos , EspañaRESUMEN
OBJECTIVE: To describe the implementation of a unitary dose drug dispensation system (UDDDS) with computerized medical orders in an intensive care unit (ICU) including 10 multi-purpose offices, and to obtain a medication error index as an indicator of the process quality. METHOD: A UDDDS with computerized medical orders for intensive care was defined. By consensus among nurses, intensivists and pharmacists, the administration of high-risk drugs by perfusion or through a gastric tube was protocolized, and computerized medical orders were adapted to ICU dynamics, with both fluid therapy and enteral and parenteral nutrition becoming fully integrated. A prospective observational 8-month study with 15 cross-sectional time points was performed to estimate the overall error index and mean error per drug use process stage. The error index is estimated by dividing the number of errors into error opportunities, and is expressed as a percentage. RESULTS: Computerized medical orders favored compliance with consensus protocols defined in software programs at the pharmacy department, even though the degree of adhesion degree was not quantitized. They also allowed a validation of all medical prescriptions by a pharmacist before dispensation. The total number of errors detected during the study period was 86. Error opportunities were 26,695, and the overall error index was 0.32%. During the study an error occurred every 312.5 error opportunities.
Asunto(s)
Unidades de Cuidados Intensivos , Sistemas de Entrada de Órdenes Médicas , Sistemas de Medicación en Hospital/organización & administración , Errores de Medicación/estadística & datos numéricos , Estudios ProspectivosRESUMEN
Objetivo. Descripción del empleo simultáneo de tirofibán y clopidogrel en el síndrome coronario agudo sin elevación persistente del segmento ST (SCASEST) de alto riesgo. Diseño. Estudio de cohorte de comienzo, prospectivo, incluyendo pacientes durante 12 meses, con seguimiento desde el ingreso en Unidad de Cuidados Intensivos (UCI) hasta el alta hospitalaria. Ámbito. UCI de un hospital sin laboratorio de hemodinámica. Pacientes. Muestra consecutiva de 56 pacientes con SCASEST que presentaban ascenso transitorio del segmento ST, descenso del mismo o elevación de la troponina Ic. Se excluyeron posteriormente 4 pacientes por no cumplir los criterios de inclusión. Todos completaron el período de seguimiento. Intervenciones. Los pacientes fueron tratados con ácido acetilsalicílico, clopidogrel, tirofibán, heparina sódica y medicación antiisquémica, según las indicaciones de las guías de consenso en vigor. Se solicitó cateterismo cardíaco cuando apareció angina refractaria, fallo ventricular o inestabilidad hemodinámica. Variables principales. Se registraron los eventos isquémicos durante el período de seguimiento, la realización de cateterismo cardíaco y las complicaciones hemorrágicas.Resultados. Durante el ingreso en la UCI 21 pacientes (40,3%) presentaron ángor de repetición y/o fallo ventricular izquierdo y dos pacientes (3,8%) fallecieron. En la planta de hospitalización 6 pacientes (12%) sufrieron ángor de repetición y/o fallo ventricular izquierdo. Se realizó cateterismo en 11 pacientes (21,1%) desde la UCI y en 20 (40%) desde la planta de hospitalización. Se registraron 2 hemorragias graves (3,8%) y una trombocitopenia (1,9%). Conclusiones. La aparición de complicaciones en el SCASEST de alto riesgo es frecuente, incluso cuando se emplean simultáneamente tirofibán y clopidogrel. Para conocer si esta estrategia terapéutica puede contribuir a la estabilización clínica de los pacientes con SCASEST se requieren estudios con tirofibán sólo. El riesgo hemorrágico del empleo de tirofibán con clopidogrel es aceptable
Objective. Description of simultaneous use of tirofiban and clopidogrel in the high risk acute coronary syndrome without persistent ST segment elevation (SCASEST). Design. Prospective, onset cohort study, including patients for 12 months, with follow-up from admission to ICU until hospital discharge. Scope. Intensive Care Unit (ICU) of a hospital without hemodynamic laboratory. Patients. Consecutive sample of 56 patients with SCASEST who had transitory increase of ST segment, decrease of it or elevation of troponin Ic. Four patients were excluded later as they did not comply with the inclusion criteria. All completed the follow-up period. Interventions. The patients were treated with aspirin, clopidogrel, tirofiban, heparin sodium and anti-ischemic medication according to the consensus guidelines in force. Cardiac catheterism was requested when refractory angina, ventricular failure or hemodynamic instability appeared. Primary endpoints. The ischemic events were recorded during the follow-up period, the performance of the cardiac catheterism and the bleeding complications. Results. During the admission in the ICU, 21 patients (40.3%) had recurrent angina and/or left ventricular failure. Two patients (3.8%) died. Six patients (12%) in the hospitalization ward had recurrent angina and/or left ventricular failure. Catheterism was done in 11 patients (21.1%) from the ICU and in 20 (40%) from the hospitalization ward. Two serious bleedings (3.8%) and one thrombocytopenia (1.9%) were recorded. Conclusions. The appearance of complications in high risk SCASEST is frequent, even when tirofiban and clopidogrel are used simultaneously. To know if this therapeutic strategy may contribute to clinical stabilization of SCASEST patients, studies versus tirofiban alone are required. Bleeding risk due to the use of tirofiban with clopidogrel is acceptable
Asunto(s)
Masculino , Femenino , Humanos , Enfermedad Coronaria/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/administración & dosificación , Anticoagulantes/administración & dosificación , Aspirina/administración & dosificación , Heparina/administración & dosificación , Angina de Pecho/tratamiento farmacológico , Angina de Pecho/epidemiología , Cateterismo CardíacoRESUMEN
Severe thoracic trauma is a common cause of admission in Intensive Care Units; then heart injury is not a rare finding. We present a case of post-traumatic interventricular dissection and ventricular aneurysm secondary to thoracic trauma caused by traffic accident. We think that ventricular septum injury is a rare finding after chest trauma. Two-dimensional echo-cardiography is an essential procedure in the diagnosis of traumatic heart injury.