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4.
Trials ; 20(1): 349, 2019 Jun 11.
Artigo em Inglês | MEDLINE | ID: mdl-31186035

RESUMO

BACKGROUND: Normal levels of plasma antithrombin (AT) activity might decrease heparin requirements to achieve an adequate level of anticoagulation during treatment with extracorporeal membrane oxygenation (ECMO). Acquired AT deficiency during ECMO is common, but formal recommendations on target, timing, and rate of AT supplementation are lacking. Thus, we conceived a pilot trial to evaluate the feasibility and safety of prolonged AT supplementation in patients requiring veno-venous ECMO for respiratory failure. METHODS: Grifols Antithrombin Research Awards (GATRA) is a prospective, randomized, single blinded, multicenter, controlled two-arm trial. Patients undergoing veno-venous ECMO will be randomized to either receive AT supplementation to maintain a functional AT level between 80 and 120% (AT supplementation group) or not (control group) for the entire ECMO course. In both study groups, anticoagulation will be provided with unfractionated heparin following a standardized protocol. The primary endpoint will be the dose of heparin required to maintain the ratio of activated partial thromboplastin time between 1.5 and 2. Secondary endpoints will be the adequacy of anticoagulation and the incidence of hemorrhagic and thrombotic complications. DISCUSSION: GATRA is a pilot trial that will test the efficacy of a protocol of AT supplementation in decreasing the heparin dose and improving anticoagulation adequacy during ECMO. If positive, it might provide the basis for a future larger trial aimed at verifying the impact of AT supplementation on a composite outcome endpoint including hemorrhagic events, transfusion requirements, and mortality. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03208270 . Registered on 5 July 2017.

5.
N. Engl. j. med. ; 380(13): 1214-1225, Mar. 2019. gráfico, tabela
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1024163

RESUMO

BACKGROUND: Volatile (inhaled) anesthetic agents have cardioprotective effects, which might improve clinical outcomes in patients undergoing coronary-artery bypass grafting (CABG). METHODS: We conducted a pragmatic, multicenter, single-blind, controlled trial at 36 centers in 13 countries. Patients scheduled to undergo elective CABG were randomly assigned to an intraoperative anesthetic regimen that included a volatile anesthetic (desflurane, isoflurane, or sevoflurane) or to total intravenous anesthesia. The primary outcome was death from any cause at 1 year. RESULTS: A total of 5400 patients were randomly assigned: 2709 to the volatile anesthetics group and 2691 to the total intravenous anesthesia group. On-pump CABG was performed in 64% of patients, with a mean duration of cardiopulmonary bypass of 79 minutes. The two groups were similar with respect to demographic and clinical characteristics at baseline, the duration of cardiopulmonary bypass, and the number of grafts. At the time of the second interim analysis, the data and safety monitoring board advised that the trial should be stopped for futility. No significant difference between the groups with respect to deaths from any cause was seen at 1 year (2.8% in the volatile anesthetics group and 3.0% in the total intravenous anesthesia group; relative risk, 0.94; 95% confidence interval [CI], 0.69 to 1.29; P = 0.71), with data available for 5353 patients (99.1%), or at 30 days (1.4% and 1.3%, respectively; relative risk, 1.11; 95% CI, 0.70 to 1.76), with data available for 5398 patients (99.9%). There were no significant differences between the groups in any of the secondary outcomes or in the incidence of prespecified adverse events, including myocardial infarction. CONCLUSIONS: Among patients undergoing elective CABG, anesthesia with a volatile agent did not result in significantly fewer deaths at 1 year than total intravenous anesthesia. (Funded by the Italian Ministry of Health; MYRIAD ClinicalTrials.gov number, NCT02105610.). (AU)


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Ponte de Artéria Coronária , Anestésicos Inalatórios , Anestesia Geral , Anestesia Intravenosa
6.
N Engl J Med ; 380(13): 1214-1225, 2019 03 28.
Artigo em Inglês | MEDLINE | ID: mdl-30888743

RESUMO

BACKGROUND: Volatile (inhaled) anesthetic agents have cardioprotective effects, which might improve clinical outcomes in patients undergoing coronary-artery bypass grafting (CABG). METHODS: We conducted a pragmatic, multicenter, single-blind, controlled trial at 36 centers in 13 countries. Patients scheduled to undergo elective CABG were randomly assigned to an intraoperative anesthetic regimen that included a volatile anesthetic (desflurane, isoflurane, or sevoflurane) or to total intravenous anesthesia. The primary outcome was death from any cause at 1 year. RESULTS: A total of 5400 patients were randomly assigned: 2709 to the volatile anesthetics group and 2691 to the total intravenous anesthesia group. On-pump CABG was performed in 64% of patients, with a mean duration of cardiopulmonary bypass of 79 minutes. The two groups were similar with respect to demographic and clinical characteristics at baseline, the duration of cardiopulmonary bypass, and the number of grafts. At the time of the second interim analysis, the data and safety monitoring board advised that the trial should be stopped for futility. No significant difference between the groups with respect to deaths from any cause was seen at 1 year (2.8% in the volatile anesthetics group and 3.0% in the total intravenous anesthesia group; relative risk, 0.94; 95% confidence interval [CI], 0.69 to 1.29; P = 0.71), with data available for 5353 patients (99.1%), or at 30 days (1.4% and 1.3%, respectively; relative risk, 1.11; 95% CI, 0.70 to 1.76), with data available for 5398 patients (99.9%). There were no significant differences between the groups in any of the secondary outcomes or in the incidence of prespecified adverse events, including myocardial infarction. CONCLUSIONS: Among patients undergoing elective CABG, anesthesia with a volatile agent did not result in significantly fewer deaths at 1 year than total intravenous anesthesia. (Funded by the Italian Ministry of Health; MYRIAD ClinicalTrials.gov number, NCT02105610.).


Assuntos
Anestesia Intravenosa , Anestésicos Gerais/farmacologia , Ponte de Artéria Coronária , Doença da Artéria Coronariana/cirurgia , Administração por Inalação , Idoso , Anestesia Geral , Anestésicos Intravenosos , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/fisiopatologia , Procedimentos Cirúrgicos Eletivos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Mortalidade , Método Simples-Cego , Volume Sistólico
7.
J Heart Lung Transplant ; 38(3): 267-276, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30642797

RESUMO

BACKGROUND: Lung metabolism during ex vivo lung perfusion (EVLP) is increasingly studied. Microdialysis (MD) allows metabolic monitoring by sampling parenchymal interstitial fluid. This study investigated lung metabolism using MD during EVLP and evaluated whether microdialysate metabolites could improve selection and discriminate outcome of donor lungs. METHODS: MD monitoring was used during 14 clinical EVLP procedures. Paired microdialysate and perfusate samples were analyzed for glucose, lactate, pyruvate, glutamate, and the lactate/pyruvate (L/P) ratio, and values that best discriminated an unfavorable outcome were determined. Outcome was defined as unfavorable (lungs not transplanted or transplanted with primary graft dysfunction at 72 hours ≥ 2) or favorable (lungs transplanted with primary graft dysfunction < 2). RESULTS: Microdialysate markers and the perfusate L/P ratio could discriminate unfavorable outcome with sensitivity and specificity of 0.85 and 0.81 for MD glutamate > 18.4 µmol/liter, 0.81 and 0.74 for MD lactate > 685 µmol/liter, 0.92 and 0.75 for MD glucose > 530 µmol/liter, 0.85 and 0.65 for MD pyruvate > 25 µmol/liter, and 0.73 and 0.67 for perfusate L/P ratio > 24.17. All microdialysate markers, perfusate and microdialysate L/P ratio, and perfusate lactate discriminated outcome when we limited analysis only to transplanted lungs. CONCLUSIONS: We report the use of MD to evaluate lung metabolism during clinical EVLP, demonstrating that MD metabolites can contribute to selection of reconditioned lungs and discriminate early outcome after transplantation. Furthermore, glutamate as a marker of lung injury during EVLP is proposed and could hence be used as a potential target for future therapies.

8.
Minerva Anestesiol ; 2018 Oct 30.
Artigo em Inglês | MEDLINE | ID: mdl-30394062

RESUMO

BACKGROUND: During orthotopic liver transplantation (OLT), liver graft ischemia-reperfusion injury (IRI) triggers a cytokine-mediated systemic inflammatory response, which impairs graft function and disrupts distal organ homeostasis. The objective of this prospective, observational trial was to assess the effects of IRI on lung and chest wall mechanics in the intraoperative period of patients undergoing OLT. METHODS: In 26 patients undergoing OLT, we measured elastance of the respiratory system (ERS), partitioned into lung (EL) and chest wall (ECW), hemodynamics, and fluid and blood product intake before laparotomy (T1), after portal/caval surgical clamp (T2), and immediately (T3) and, at 90 and 180 min post-reperfusion (T4 and T5, respectively). IL-6, MCP-1, IL-1ß and TNF-α plasma concentrations were assessed at T1, T4 and T5. RESULTS: EL significantly decreased from T1 to T2 (13.5±4.4 vs 9.7±4.8 cmH2O L-1, p<0.05), remained stable at T3, while at T4 (12.3±4.4 cmH2O L-1, p<0.05) was well above levels recorded at T2, reaching its highest value at T5 (15±3.9 cmH2O L-1, p< 0.05). Variations in ERS, EL, driving pressure (∆P) and trans-pulmonary pressure (∆PL) significantly correlated with changes in IL-6 and MCP-1 plasma concentrations, but not with changes in wedge pressure, fluid amounts, and red blood cells and platelets administered. No correlation was found between changes in cytokine concentrations and ECW. CONCLUSIONS: We found that EL, ECW, ∆P and ∆PL underwent significant variations during the OLT procedure. Further, we documented a significant association between the respiratory mechanics changes and the inflammatory response following liver graft reperfusion.

9.
Minerva Anestesiol ; 2018 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-29991221

RESUMO

More than two-thirds of critically ill patients receive an antimicrobial therapy with a percentage between 30 and 50% of all prescribed antibiotics reported to be unnecessary, inappropriate or misused. Since inappropriate prescription of antibiotic drugs concurs to dissemination of the multi-drug resistant organisms, a reasoned antibiotics use is crucial especially in Intensive Care Unit (ICU), where up to 60% of the admitted patients develops an infection during their ICU stay. Even if the concept of Antimicrobial Stewardship (AS) has been clearly described as a series of coordinated interventions designed to improve antimicrobial agents use, few studies are reporting about its effectiveness to improve outcomes, reduce adverse events and costs and decrease resistance rate spread. Moreover, although it is recognized that AS programs are particularly indicated in the critical setting due to the huge number of antimicrobial drugs used, the optimal characteristics of these interventions and the best system to evaluate their effectiveness are still unclear. Specific interventions, designed tacking into account the peculiarities of the ICU setting, are hence necessary to set-up an 'in-ICU-stewardship', including prompt identification of infected patients, selection of appropriate empiric treatments, optimization of dosing and route of administration, improvement of diagnostic techniques, early de-escalation to achieve shorter duration and avoid unnecessary therapies. The present narrative review summarizes the "state of art" about AS programmes and discusses the effects of the interventions possibly applied in ICU setting to optimize the patient's treatment, reduce the micro-organisms resistance and contain the hospital resources utilization.

11.
Drugs Context ; 7: 212524, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29675049

RESUMO

Background: Acute pain is among the leading causes of referral to the emergency department (ED) in industrialized countries. Its management mainly depends on intensity. Moderate-to-severe pain is treated with intravenous (IV) administered opioids, of which morphine is the most commonly used in the ED. We have estimated the burden of IV administration of morphine in the five key European countries (EU5) using a micro-costing approach. Scope: A structured literature review was conducted to identify clinical guidelines for acute pain management in EU5 and clinical studies conducted in the ED setting. The data identified in this literature review constituted the source for all model input parameters, which were clustered as analgesic (morphine), material used for IV morphine administration, nurse workforce time and management of morphine-related adverse events and IV-related complications. Findings: The cost per patient of IV morphine administration in the ED ranges between €18.31 in Spain and €28.38 in Germany. If costs associated with the management of morphine-related adverse events and IV-related complications are also considered, the total costs amount to €121.13-€132.43. The main driver of those total costs is the management of IV-related complications (phlebitis, extravasation and IV prescription errors; 73% of all costs) followed by workforce time (14%). Conclusions: IV morphine provides effective pain relief in the ED, but the costs associated with the IV administration inflict an economic burden on the respective national health services in EU5. An equally rapid-onset and efficacious analgesic that does not require IV administration could reduce this burden.

12.
Minerva Anestesiol ; 84(6): 712-719, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29516708

RESUMO

BACKGROUND: The feasibility and safety of transanal endoscopic microsurgery (TEM) performed under spinal anesthesia (SA) has been recently demonstrated. This retrospective study compared the differences in opioid consumption and postoperative recovery in patients undergoing TEM under GA and SA. METHODS: All consecutive patients who underwent TEM at Città della Salute e della Scienza Hospital of Turin (Italy) between January 2012 and December 2015 were enrolled. Data related to demographic characteristics, surgery, anesthesia management and postoperative course were recorded from the hospital electronic registry of medical records. Patients were treated according to a standardized protocol by a team of three anesthesiologists with experience in both GA and SA. RESULTS: The study included 148 patients: 77 in GA group and 71 in SA, with no switch among groups. Hospital length of stay was shorter in SA group (3 vs. 4 days, P=0.0201). SA patients were earlier mobilized and applied to oral postoperative intake (18 vs. 24 hours and 24 vs. 48 hours, respectively, P<0.0001). Peri-procedural complications, postoperative nausea, vomiting and pain were comparable between groups. Percentage of patients requiring postoperative rescue therapy with Tramadol was similar between groups, but SA patients received a lower opioid dosage (176.6±67.8 mg vs. 238.3±79.5 mg, P=0.0011). Operating room occupancy times was longer in GA group (120 vs. 100 minutes, P=0.0008). CONCLUSIONS: SA seems to be the treatment of choice, when not contraindicated, in patients undergoing TEM, allowing a reduction in perioperative opioid consumption and a faster postoperative recovery.

13.
J Cardiothorac Vasc Anesth ; 32(5): 2152-2159, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-29580796

RESUMO

OBJECTIVE: Acute kidney injury (AKI) occurs frequently after cardiac surgery. Levosimendan might reduce the incidence of AKI in patients undergoing cardiac surgery. The authors investigated whether levosimendan administration could reduce AKI incidence in a high-risk cardiac surgical population. DESIGN: Post hoc analysis of a multicenter randomized trial. SETTING: Cardiac surgery operating rooms and intensive care units of 14 centers in 3 countries. PARTICIPANTS: The study comprised 90 patients who underwent mitral valve surgery with an estimated glomerular filtration rate <60 mL/min/1.73 m2 and perioperative myocardial dysfunction. INTERVENTIONS: Patients were assigned randomly to receive levosimendan (0.025-0.2 µg/kg/min) or placebo in addition to standard inotropic treatment. MEASUREMENTS AND MAIN RESULTS: Forty-six patients were assigned to receive levosimendan and 44 to receive placebo. Postoperative AKI occurred in 14 (30%) patients in the levosimendan group versus 23 (52%) in the placebo group (absolute difference -21.8; 95% confidence interval -41.7 to -1.97; p = 0.035). The incidence of major complications also was lower (18 [39%]) in the levosimendan group versus that in the placebo group (29 [66%]) (absolute difference -26.8 [-46.7 to -6.90]; p = 0.011). A trend toward lower serum creatinine at intensive care unit discharge was observed in the levosimendan group (1.18 [0.99-1.49] mg/dL) versus that in the placebo group (1.39 [1.05-1.76] mg/dL) (95% confidence interval -0.23 [-0.49 to 0.01]; p = 0.07). CONCLUSIONS: Levosimendan may improve renal outcome in cardiac surgery patients with chronic kidney disease undergoing mitral valve surgery who develop perioperative myocardial dysfunction. Results of this exploratory analysis should be investigated in future properly designed randomized controlled trials.

17.
J Cardiothorac Vasc Anesth ; 32(1): 225-235, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29122431

RESUMO

OBJECTIVE: A careful choice of perioperative care strategies is pivotal to improve survival in cardiac surgery. However, there is no general agreement or particular attention to which nonsurgical interventions can reduce mortality in this setting. The authors sought to address this issue with a consensus-based approach. DESIGN: A systematic review of the literature followed by a consensus-based voting process. SETTING: A web-based international consensus conference. PARTICIPANTS: More than 400 physicians from 52 countries participated in this web-based consensus conference. INTERVENTIONS: The authors identified all studies published in peer-reviewed journals that reported on interventions with a statistically significant effect on mortality in the setting of cardiac surgery through a systematic Medline/PubMed search and contacts with experts. These studies were discussed during a consensus meeting and those considered eligible for inclusion in this study were voted on by clinicians worldwide. MEASUREMENTS AND MAIN RESULTS: Eleven interventions finally were selected: 10 were shown to reduce mortality (aspirin, glycemic control, high-volume surgeons, prophylactic intra-aortic balloon pump, levosimendan, leuko-depleted red blood cells transfusion, noninvasive ventilation, tranexamic acid, vacuum-assisted closure, and volatile agents), whereas 1 (aprotinin) increased mortality. A significant difference in the percentages of agreement among different countries and a variable gap between agreement and clinical practice were found for most of the interventions. CONCLUSIONS: This updated consensus process identified 11 nonsurgical interventions with possible survival implications for patients undergoing cardiac surgery. This list of interventions may help cardiac anesthesiologists and intensivists worldwide in their daily clinical practice and can contribute to direct future research in the field.


Assuntos
Procedimentos Cirúrgicos Cardíacos/mortalidade , Procedimentos Cirúrgicos Cardíacos/tendências , Conferências de Consenso como Assunto , Assistência Perioperatória/métodos , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/prevenção & controle , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Congressos como Assunto/tendências , Consenso , Humanos , Internet/tendências , Mortalidade/tendências , Assistência Perioperatória/tendências , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
19.
Pediatr Emerg Care ; 34(8): 545-551, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27415643

RESUMO

OBJECTIVES: Apparent life-threatening event (ALTE) refers to a constellation of unexpected events suddenly occurring in infants that extremely alarm the observers. The objectives of this study were to evaluate 1) intervention of Emergency Service (ES) at home, 2) parental behavior before ES intervention, 3) patients' outcome at follow-up of a minimum of 6 months. METHODS: Retrospective study of infants younger than 12 months whose parents called ES and were evaluated for ALTE from 2005 to 2014. Tactile stimulation (TS) was defined as any maneuver performed by parents or ES staff aimed at rescuing patients without cardiopulmonary resuscitation attempts. Cardiopulmonary resuscitation was defined according to American Heart Association Guidelines 2010. RESULTS: One hundred eighty-eight patients were eligible. Emergency Service provided intervention for 178 infants (10 were assisted only by phone). All patients received TS by parents before ES arrival. Mean time for ES to reach patient location was 15 ± 10 minutes. On examination, 136 patients (76.5%) seemed normal and 42 symptomatic. One hundred sixty-three patients were brought to the emergency department where 23 patients were found symptomatic. One hundred six of 163 patients underwent capillary blood gas determination and, in 28 (26%) of 106, alterations were found. No infant had subsequent cardiopulmonary arrest or clinically evident adverse neurological outcome. Six were found to be epileptic. No infant died during the episode or during follow-up. CONCLUSIONS: Our findings suggest that ALTE is an alarming but self-limiting phenomenon that can be resolved either spontaneously or by simple TS in most cases. Emergency Service should solicit patients' physiological responses through TS first while considering a cardiopulmonary resuscitation maneuver.


Assuntos
Emergências/epidemiologia , Serviços Médicos de Emergência/estatística & dados numéricos , Feminino , Seguimentos , Humanos , Lactente , Recém-Nascido , Masculino , Avaliação de Resultados (Cuidados de Saúde) , Pais , Estudos Retrospectivos
20.
Infection ; 46(1): 123-125, 2018 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-28776164

RESUMO

INTRODUCTION: Elizabethkingia meningoseptica can frequently colonizes the respiratory tract, but its pathogenetic role and its clinical significance are frequently questioned. However, recent data reported E. meningoseptica outbreaks in particular settings, as hospitalized patients. CASE REPORT: We report here the first case of Elizabethkingia meningoseptica infection in Italy in a patient with necrotic-hemorrhagic pancreatitis. E. meningoseptica was isolated from respiratory tract and treated with combination antibiotic therapy. CONCLUSION: We discuss here the role of isolation of E. meningoseptica in hospitalized patients as a sign of patient's frailty.


Assuntos
Antibacterianos/uso terapêutico , Chryseobacterium/isolamento & purificação , Infecção Hospitalar/diagnóstico , Infecções por Flavobacteriaceae/diagnóstico , Pancreatite/complicações , Infecções Respiratórias/diagnóstico , Idoso , Infecção Hospitalar/tratamento farmacológico , Infecção Hospitalar/microbiologia , Infecções por Flavobacteriaceae/tratamento farmacológico , Infecções por Flavobacteriaceae/microbiologia , Hemorragia/complicações , Humanos , Itália , Masculino , Necrose/complicações , Infecções Respiratórias/tratamento farmacológico , Infecções Respiratórias/microbiologia , Resultado do Tratamento
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