RESUMO
BACKGROUND: Liver failure patients have traditionally been empirically transfused prior to invasive procedures. Blood transfusion is associated with immunologic and nonimmunologic reactions, increased risk of adverse outcomes and high costs. Scientific evidence supporting empirical transfusion is lacking, and the best approach for blood transfusion prior to invasive procedures in cirrhotic patients has not been established so far. The aim of this study is to compare three transfusion strategies (routine coagulation test-guided - ordinary or restrictive, or thromboelastometry-guided) prior to central venous catheterization in critically ill patients with cirrhosis. METHODS/DESIGN: Design and setting: a double-blinded, parallel-group, single-center, randomized controlled clinical trial in a tertiary private hospital in São Paulo, Brazil. INCLUSION CRITERIA: adults (aged 18 years or older) admitted to the intensive care unit with cirrhosis and an indication for central venous line insertion. Patients will be randomly assigned to three groups for blood transfusion strategy prior to central venous catheterization: standard coagulation tests-based, thromboelastometry-based, or restrictive. The primary efficacy endpoint will be the proportion of patients transfused with any blood product prior to central venous catheterization. The primary safety endpoint will be the incidence of major bleeding. Secondary endpoints will be the proportion of transfusion of fresh frozen plasma, platelets and cryoprecipitate; infused volume of blood products; hemoglobin and hematocrit before and after the procedure; intensive care unit and hospital length of stay; 28-day and hospital mortality; incidence of minor bleeding; transfusion-related adverse reactions; and cost analysis. DISCUSSION: This study will evaluate three strategies to guide blood transfusion prior to central venous line placement in severely ill patients with cirrhosis. We hypothesized that thromboelastometry-based and/or restrictive protocols are safe and would significantly reduce transfusion of blood products in this population, leading to a reduction in costs and transfusion-related adverse reactions. In this manner, this trial will add evidence in favor of reducing empirical transfusion in severely ill patients with coagulopathy. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02311985 . Retrospectively registered on 3 December 2014.
Assuntos
Testes de Coagulação Sanguínea/métodos , Coagulação Sanguínea , Transfusão de Sangue , Cateterismo Venoso Central , Cirrose Hepática/terapia , Tromboelastografia , Testes de Coagulação Sanguínea/economia , Transfusão de Sangue/economia , Transfusão de Sangue/mortalidade , Brasil , Cateterismo Venoso Central/efeitos adversos , Cateterismo Venoso Central/economia , Cateterismo Venoso Central/mortalidade , Protocolos Clínicos , Análise Custo-Benefício , Estado Terminal , Método Duplo-Cego , Custos Hospitalares , Mortalidade Hospitalar , Hospitais Privados , Humanos , Tempo de Internação , Cirrose Hepática/sangue , Cirrose Hepática/diagnóstico , Cirrose Hepática/mortalidade , Valor Preditivo dos Testes , Projetos de Pesquisa , Fatores de Risco , Centros de Atenção Terciária , Fatores de Tempo , Reação Transfusional , Resultado do TratamentoRESUMO
BACKGROUND: In the current medical practice, central venous catheters (CVC) are very useful; however, their use involves certain risks, which increase morbidity and mortality, especially in newborns. The aim of this study was to describe both the frequency of complications and survival of CVC placed in newborns hospitalized in a third level neonatal intensive care unit (NICU). METHODS: A descriptive, observational and prospective study was carried-out in the NICU from the Hospital de Pediatría, Centro Médico Nacional Siglo XXI. Demographic, perinatal and CVC variables were recorded. RESULTS: We included 152 CVCs, which were inserted in 123 newborns. For the CVC insertion, the puncture technique [percutaneous and subclavian] was used in 56.6 % (n = 86). There was at least one complication in 48.7 %.(n = 74). The most frequent complications were colonization 32.4 % (n = 24) and CVC-related bacteremia in 27 % (n = 20). Survival probability for CVC was 93.4 % at 10 days and 91.4 % at 17 days. Kaplan-Meier survival analysis demonstrated significantly lower survival probability for non-central catheters. CONCLUSIONS: Most of CVC complications occurred within the first two weeks after these CVC were installed. Infectious complications were the most frequent.
Introducción: los catéteres venosos centrales (CVC) son de gran utilidad en la práctica médica actual; sin embargo, no están exentos de riesgos, lo que incrementa la morbilidad y mortalidad, especialmente en los recién nacidos (RN). El objetivo fue registrar la frecuencia de complicaciones de los CVC y su duración en RN en una unidad de cuidados intensivos neonatales (UCIN) de tercer nivel. Métodos: se realizó un estudio observacional descriptivo, prolectivo en la UCIN del Hospital de Pediatría del Centro Médico Nacional Siglo XXI. Se registraron variables demográficas, perinatales y del CVC. Resultados: se incluyeron 123 RN a quienes se les colocaron 152 CVC. La técnica más usada para la inserción del CVC fue la punción (percutánea o subclavia) en 56.6 % (n = 86). En 48.7 % (n = 74) de los CVC se presentó alguna complicación. Las más frecuentes fueron colonización en 32.4 % (n = 24) y bacteriemia relacionada con CVC en 27 % (n = 20). La probabilidad de duración de los CVC libres de complicaciones fue de 93.4 % a los 10 días y de 91.4 % a los 17 días. Los catéteres venosos no centrales tuvieron menor probabilidad de duración. Conclusión: la mayoría de las complicaciones de los CVC se presentaron en las primeras dos semanas de haber sido instalados. Las complicaciones infecciosas fueron las más frecuentes.
Assuntos
Bacteriemia/epidemiologia , Infecções Relacionadas a Cateter/epidemiologia , Cateterismo Venoso Central/efeitos adversos , Cateterismo Venoso Central/mortalidade , Terapia Intensiva Neonatal , Bacteriemia/etiologia , Infecções Relacionadas a Cateter/etiologia , Feminino , Infecções por Bactérias Gram-Negativas/epidemiologia , Infecções por Bactérias Gram-Negativas/etiologia , Infecções por Bactérias Gram-Positivas/epidemiologia , Infecções por Bactérias Gram-Positivas/etiologia , Hospitais Pediátricos , Humanos , Recém-Nascido , Unidades de Terapia Intensiva Neonatal , Terapia Intensiva Neonatal/métodos , Estimativa de Kaplan-Meier , Masculino , México , Estudos Prospectivos , Taxa de SobrevidaRESUMO
PURPOSE: To evaluate the impact of country socioeconomic status and hospital type on device-associated healthcare-associated infections (DA-HAIs) in neonatal intensive care units (NICUs). METHODS: Data were collected on DA-HAIs from September 2003 to February 2010 on 13,251 patients in 30 NICUs in 15 countries. DA-HAIs were defined using criteria formulated by the Centers for Disease Control and Prevention. Country socioeconomic status was defined using World Bank criteria. RESULTS: Central-line-associated bloodstream infection (CLA-BSI) rates in NICU patients were significantly lower in private than academic hospitals (10.8 vs. 14.3 CLA-BSI per 1,000 catheter-days; p < 0.03), but not different in public and academic hospitals (14.6 vs. 14.3 CLA-BSI per 1,000 catheter-days; p = 0.86). NICU patient CLA-BSI rates were significantly higher in low-income countries than in lower-middle-income countries or upper-middle-income countries [37.0 vs. 11.9 (p < 0.02) vs. 17.6 (p < 0.05) CLA-BSIs per 1,000 catheter-days, respectively]. Ventilator-associated-pneumonia (VAP) rates in NICU patients were significantly higher in academic hospitals than in private or public hospitals [13.2 vs. 2.4 (p < 0.001) vs. 4.9 (p < 0.001) VAPs per 1,000 ventilator days, respectively]. Lower-middle-income countries had significantly higher VAP rates than low-income countries (11.8 vs. 3.8 per 1,000 ventilator-days; p < 0.001), but VAP rates were not different in low-income countries and upper-middle-income countries (3.8 vs. 6.7 per 1,000 ventilator-days; p = 0.57). When examined by hospital type, overall crude mortality for NICU patients without DA-HAIs was significantly higher in academic and public hospitals than in private hospitals (5.8 vs. 12.5%; p < 0.001). In contrast, NICU patient mortality among those with DA-HAIs was not different regardless of hospital type or country socioeconomic level. CONCLUSIONS: Hospital type and country socioeconomic level influence DA-HAI rates and overall mortality in developing countries.
Assuntos
Infecções Relacionadas a Cateter/mortalidade , Infecção Hospitalar/epidemiologia , Países em Desenvolvimento , Unidades de Terapia Intensiva Neonatal , Pneumonia Associada à Ventilação Mecânica/mortalidade , Infecções Relacionadas a Cateter/epidemiologia , Infecções Relacionadas a Cateter/microbiologia , Cateterismo Venoso Central/efeitos adversos , Cateterismo Venoso Central/instrumentação , Cateterismo Venoso Central/mortalidade , Infecção Hospitalar/sangue , Infecção Hospitalar/microbiologia , Infecção Hospitalar/mortalidade , Contaminação de Equipamentos , Hospitais Privados/classificação , Hospitais Públicos/classificação , Hospitais de Ensino/classificação , Humanos , Recém-Nascido , Pneumonia Associada à Ventilação Mecânica/epidemiologia , Estudos Prospectivos , Fatores Socioeconômicos , Ventiladores Mecânicos/efeitos adversos , Ventiladores Mecânicos/microbiologiaRESUMO
BACKGROUND: Limited information is available on the financial impact of central venous catheter-associated bloodstream infection (BSI) in Argentina. To calculate the cost of BSIs in the intensive care department (ICU), a 5-year prospective nested case-control study was undertaken at 3 hospitals in Argentina. METHODS: We studied 6 adult ICUs from 3 hospitals. In all, 142 patients with BSI and 142 control patients without BSI were matched for hospital, type of ICU, year of admission, length of stay, sex, age, and average severity of illness score. Patients' length of stay in the ICU was obtained prospectively on daily rounds. The hospitals' finance departments provided the cost of each ICU day. The hospitals' pharmacies provided the cost of antibiotics prescribed for BSIs. RESULTS: The mean extra length of stay for patients with BSI compared with control patients was 11.9 days, the mean extra antibiotic defined daily dose was 22.6, the mean extra antibiotic cost was $1913, the mean extra cost was $4888.42, and the excess mortality was 24.6%. CONCLUSIONS: In this study, patients with central venous catheter-associated BSI experienced significant prolongation of hospitalization, increased use of health care costs, and a higher attributable mortality. These findings support the need to implement preventative interventions for patients hospitalized with central venous catheters in Argentina.
Assuntos
Cateterismo Venoso Central/economia , Cateterismo Venoso Central/mortalidade , Unidades de Terapia Intensiva/estatística & dados numéricos , Sepse/economia , Sepse/mortalidade , Idoso , Argentina/epidemiologia , Estudos de Casos e Controles , Estudos de Coortes , Feminino , Custos Hospitalares , Mortalidade Hospitalar , Humanos , Tempo de Internação , Masculino , Estudos Prospectivos , Sepse/epidemiologia , Índice de Gravidade de DoençaAssuntos
Fatores de Risco , Infecções por Bactérias Gram-Negativas , Infecções Estafilocócicas , Staphylococcus aureus , Cateterismo Periférico/economia , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/mortalidade , Micoses , Infecção Hospitalar/epidemiologia , Infecção Hospitalar/etiologia , Infecção Hospitalar/prevenção & controle , Infecção Hospitalar/microbiologia , Cateterismo Venoso Central/economia , Cateterismo Venoso Central/efeitos adversos , Cateterismo Venoso Central/mortalidade , Sepse/prevenção & controle , Infecções/diagnóstico , Infecções/epidemiologia , Infecções/etiologia , Infecções/microbiologia , Infecções/mortalidade , Controle de Infecções , Análise Custo-Eficiência , Surtos de DoençasAssuntos
Análise Custo-Eficiência , Cateterismo Periférico/economia , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/mortalidade , Cateterismo Venoso Central/economia , Cateterismo Venoso Central/efeitos adversos , Cateterismo Venoso Central/mortalidade , Controle de Infecções , Fatores de Risco , Infecção Hospitalar/epidemiologia , Infecção Hospitalar/etiologia , Infecção Hospitalar/microbiologia , Infecção Hospitalar/prevenção & controle , Infecções Estafilocócicas , Infecções por Bactérias Gram-Negativas , Infecções/diagnóstico , Infecções/epidemiologia , Infecções/etiologia , Infecções/microbiologia , Infecções/mortalidade , Micoses , Sepse/prevenção & controle , Staphylococcus aureus , Surtos de DoençasRESUMO
La sepsis relacionada a cateterismo venoso central (CVC) es la complicación más temida, describiéndose en la literatura una incidencia de 0 a 25 por ciento. Dentro de las complicaciones mecánicas la más frecuente es la mal posición de catéteres que llega de 5 al 13 por ciento. El objetivo de este trabajo es presentar nuestra incidencia de complicación en 116 catéteres colocados para nutrición parenteral.