RESUMO
BACKGROUND: Venous thromboembolism (VTE) is a common complication of critical illness with important clinical consequences. The Prophylaxis for ThromboEmbolism in Critical Care Trial (PROTECT) is a multicenter, blinded, randomized controlled trial comparing the effectiveness of the two most common pharmocoprevention strategies, unfractionated heparin (UFH) and low molecular weight heparin (LMWH) dalteparin, in medical-surgical patients in the intensive care unit (ICU). E-PROTECT is a prospective and concurrent economic evaluation of the PROTECT trial. METHODS/DESIGN: The primary objective of E-PROTECT is to identify and quantify the total (direct and indirect, variable and fixed) costs associated with the management of critically ill patients participating in the PROTECT trial, and, to combine costs and outcome results to determine the incremental cost-effectiveness of LMWH versus UFH, from the acute healthcare system perspective, over a data-rich time horizon of ICU admission and hospital admission. We derive baseline characteristics and probabilities of in-ICU and in-hospital events from all enrolled patients. Total costs are derived from centers, proportional to the numbers of patients enrolled in each country. Direct costs include medication, physician and other personnel costs, diagnostic radiology and laboratory testing, operative and non-operative procedures, costs associated with bleeding, transfusions and treatment-related complications. Indirect costs include ICU and hospital ward overhead costs. Outcomes are the ratio of incremental costs per incremental effects of LMWH versus UFH during hospitalization; incremental cost to prevent a thrombosis at any site (primary outcome); incremental cost to prevent a pulmonary embolism, deep vein thrombosis, major bleeding event or episode of heparin-induced thrombocytopenia (secondary outcomes) and incremental cost per life-year gained (tertiary outcome). Pre-specified subgroups and sensitivity analyses will be performed and confidence intervals for the estimates of incremental cost-effectiveness will be obtained using bootstrapping. DISCUSSION: This economic evaluation employs a prospective costing methodology concurrent with a randomized controlled blinded clinical trial, with a pre-specified analytic plan, outcome measures, subgroup and sensitivity analyses. This economic evaluation has received only peer-reviewed funding and funders will not play a role in the generation, analysis or decision to submit the manuscripts for publication. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00182143 . Date of registration: 10 September 2005.
Assuntos
Anticoagulantes/administração & dosagem , Anticoagulantes/economia , Dalteparina/administração & dosagem , Dalteparina/economia , Custos de Medicamentos , Fibrinolíticos/administração & dosagem , Fibrinolíticos/economia , Heparina/administração & dosagem , Heparina/economia , Custos Hospitalares , Tromboembolia Venosa/economia , Tromboembolia Venosa/prevenção & controle , Anticoagulantes/efeitos adversos , Austrália , Brasil , Protocolos Clínicos , Redução de Custos , Análise Custo-Benefício , Cuidados Críticos , Dalteparina/efeitos adversos , Fibrinolíticos/efeitos adversos , Heparina/efeitos adversos , Humanos , Modelos Econômicos , América do Norte , Estudos Prospectivos , Anos de Vida Ajustados por Qualidade de Vida , Projetos de Pesquisa , Arábia Saudita , Fatores de Tempo , Resultado do Tratamento , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/etiologiaRESUMO
BACKGROUND AND OBJECTIVES: The aim of our study was to assess the new diagnostic criteria of acute kidney injury (AKI) proposed by the Acute Kidney Injury Network (AKIN) in a large cohort of mechanically ventilated patients. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This is a prospective observational cohort study enrolling 2783 adult intensive care unit patients under mechanical ventilation (MV) with data on serum creatinine concentration (SCr) in the first 48 hours. The absolute and the relative AKIN diagnostic criteria (changes in SCr ≥ 0.3 mg/dl or ≥ 50% over the first 48 hours of MV, respectively) were analyzed separately. In addition, patients were classified into three groups according to their change in SCr (ΔSCr) over the first day on MV (ΔSCr): group 1, ΔSCr ≤ -0.3 mg/dl; group 2, ΔSCr between -0.3 and +0.29 mg/dl; and group 3, ΔSCr ≥ +0.3 mg/dl). The primary end point was in-hospital mortality, and secondary end points were intensive care unit and hospital length of stay, and duration of MV. RESULTS: Of 2783 patients, 803 (28.8%) had AKI according to both criteria: 431 only absolute (AKI(A)), 362 both relative and absolute (AKI(R+A)), and 10 only relative. The relative criterion identified more patients when baseline SCr (SCr0) was <0.9 mg/dl and the absolute when SCr0 was >1.5 mg/dl. The diagnosis of AKI was associated with mortality. CONCLUSIONS: Our study confirms the validity of the AKIN criteria in a population of mechanically patients and the criteria's relationship with the baseline SCr.
Assuntos
Injúria Renal Aguda/diagnóstico , Creatinina/sangue , Indicadores Básicos de Saúde , Respiração Artificial , Injúria Renal Aguda/sangue , Injúria Renal Aguda/mortalidade , Injúria Renal Aguda/terapia , Adulto , Idoso , Análise de Variância , Biomarcadores/sangue , Canadá , Distribuição de Qui-Quadrado , Europa (Continente) , Feminino , Mortalidade Hospitalar , Humanos , Unidades de Terapia Intensiva , Tempo de Internação , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Valor Preditivo dos Testes , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Arábia Saudita , Índice de Gravidade de Doença , América do Sul , Fatores de Tempo , Resultado do Tratamento , Estados UnidosRESUMO
PURPOSE: To compare characteristics and clinical outcomes of patients receiving airway pressure release ventilation (APRV) or biphasic positive airway pressure (BIPAP) to assist-control ventilation (A/C) as their primary mode of ventilatory support. The objective was to estimate if patients ventilated with APRV/BIPAP have a lower mortality. METHODS: Secondary analysis of an observational study in 349 intensive care units from 23 countries. A total of 234 patients were included who were ventilated only with APRV/BIPAP and 1,228 patients who were ventilated only with A/C. A case-matched analysis according to a propensity score was used to make comparisons between groups. RESULTS: In logistic regression analysis, the most important factor associated with the use of APRV/BIPAP was the country (196 of 234 patients were from German units). Patients with coma or congestive heart failure as the reason to start mechanical ventilation, pH <7.15 prior to mechanical ventilation, and patients who developed respiratory failure (SOFA score >2) after intubation with or without criteria of acute respiratory distress syndrome were less likely to be ventilated with APRV/BIPAP. In the case-matched analysis there were no differences in outcomes, including mortality in the intensive care unit, days of mechanical ventilation or weaning, rate of reintubation, length of stay in the intensive care unit or hospital, and mortality in the hospital. CONCLUSIONS: In this study, the APRV/BIPAP ventilation mode is being used widely across many causes of respiratory failure, but only in selected geographic areas. In our patient population we could not demonstrate any improvement in outcomes with APRV/BIPAP compared with assist-control ventilation.
Assuntos
Pressão Positiva Contínua nas Vias Aéreas/métodos , Ventilação com Pressão Positiva Intermitente/métodos , Estudos de Coortes , Pressão Positiva Contínua nas Vias Aéreas/mortalidade , Feminino , Humanos , Unidades de Terapia Intensiva , Ventilação com Pressão Positiva Intermitente/mortalidade , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Few data are available regarding the benefits of one mode over another for ventilatory support. We set out to compare clinical outcomes of patients receiving synchronized intermittent mandatory ventilation with pressure support (SIMV-PS) compared with assist-control (A/C) ventilation as their primary mode of ventilatory support. METHODS: This was a secondary analysis of an observational study conducted in 349 ICUs from 23 countries. A propensity score stratified analysis was used to compare 350 patients ventilated with SIMV-PS with 1,228 patients ventilated with A/C ventilation. The primary outcome was in-hospital mortality. RESULTS: In a logistic regression model, patients were more likely to receive SIMV-PS if they were from North America, had lower severity of illness, or were ventilated postoperatively or for trauma. SIMV-PS was less likely to be selected if patients were ventilated because of asthma or coma, or if they developed complications such as sepsis or cardiovascular failure during mechanical ventilation. In the stratified analysis according to propensity score, we did not find significant differences in the in-hospital mortality. After adjustment for propensity score, overall effect of SIMV-PS on in-hospital mortality was not significant (odds ratio, 1.04; 95% CI, 0.77-1.42; P = .78). CONCLUSIONS: In our cohort of ventilated patients, ventilation with SIMV-PS compared with A/C did not offer any advantage in terms of clinical outcomes, despite treatment-allocation bias that would have favored SIMV-PS.