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1.
J Clin Immunol ; 39(5): 470-475, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31129864

RESUMO

PURPOSE: Selective IgA deficiency (SIgAD) is the most common humoral primary immunodeficiency. Long-term follow-up data in large cohort of pediatric patients are scarce. METHODS: We report on a single-center cohort of 184 pediatric patients affected with selective IgA deficiency and describe the characteristics at diagnosis and during follow-up. RESULTS: Respiratory infections were the most common clinical finding leading to the initial diagnosis (62%). Positive family history for antibody deficiencies (selective IgA deficiency, common variable immunodeficiency) led to SIgAD diagnosis in 16% of cases. During follow-up, while the incidence of respiratory infections was not particularly high, gastrointestinal symptoms were reported in 27% of patients. Allergic manifestations were found in 23% at diagnosis and an additional 16% of patients during follow-up, leading to a prevalence of atopy of 39% among SIgAD patients. Autoimmune manifestations, excluding celiac disease, were found in 9% of affected patients during follow-up. Celiac disease was found in a high prevalence (14%). Increase of serum IgA levels to partial deficiency (9%) and normal serum levels for age (4%) was observed during follow-up. A small percentage of patients (2%) progressed to common variable immunodeficiency (CVID). CONCLUSIONS: In conclusion, this is the first study to describe a large single-center pediatric cohort of patients affected with SIgAD, revealing that overall most patients do well with regard to infections. Many develop CD, at a rate much higher than the general population. A few normalize their IgA levels. A few progress to CVID. Thus, careful follow-up is suggested to diagnose and treat potential complications earlier for avoiding potential morbidities.

2.
J Cardiothorac Vasc Anesth ; 33(10): 2685-2694, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31064730

RESUMO

OBJECTIVE: Reducing mortality is a key target in critical care and perioperative medicine. The authors aimed to identify all nonsurgical interventions (drugs, techniques, strategies) shown by randomized trials to increase mortality in these clinical settings. DESIGN: A systematic review of the literature followed by a consensus-based voting process. SETTING: A web-based international consensus conference. PARTICIPANTS: Two hundred fifty-one physicians from 46 countries. INTERVENTIONS: The authors performed a systematic literature search and identified all randomized controlled trials (RCTs) showing a significant increase in unadjusted landmark mortality among surgical or critically ill patients. The authors reviewed such studies during a meeting by a core group of experts. Studies selected after such review advanced to web-based voting by clinicians in relation to agreement, clinical practice, and willingness to include each intervention in international guidelines. MEASUREMENTS AND MAIN RESULTS: The authors selected 12 RCTs dealing with 12 interventions increasing mortality: diaspirin-crosslinked hemoglobin (92% of agreement among web voters), overfeeding, nitric oxide synthase inhibitor in septic shock, human growth hormone, thyroxin in acute kidney injury, intravenous salbutamol in acute respiratory distress syndrome, plasma-derived protein C concentrate, aprotinin in high-risk cardiac surgery, cysteine prodrug, hypothermia in meningitis, methylprednisolone in traumatic brain injury, and albumin in traumatic brain injury (72% of agreement). Overall, a high consistency (ranging from 80% to 90%) between agreement and clinical practice was observed. CONCLUSION: The authors identified 12 clinical interventions showing increased mortality supported by randomized controlled trials with nonconflicting evidence, and wide agreement upon clinicians on a global scale.

3.
Ann Card Anaesth ; 22(2): 122-135, 2019 Apr-Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30971592

RESUMO

The noble gas argon (Ar) is a "biologically" active element and has been extensively studied preclinically for its organ protection properties. This work reviews all preclinical studies employing Ar and describes the clinical uses reported in literature, analyzing 55 pertinent articles found by means of a search on PubMed and Embase. Ventilation with Ar has been tested in different models of acute disease at concentrations ranging from 20% to 80% and for durations between a few minutes up to days. Overall, lesser cell death, smaller infarct size, and better functional recovery after ischemia have been repeatedly observed. Modulation of the molecular pathways involved in cell survival, with resulting anti-apoptotic and pro-survival effects, appeared as the determinant mechanism by which Ar fulfills its protective role. These beneficial effects have been reported regardless of onset and duration of Ar exposure, especially after cardiac arrest. In addition, ventilation with Ar was safe both in animals and humans. Thus, preclinical and clinical data support future clinical studies on the role of inhalatory Ar as an organ protector.

4.
J Cardiothorac Vasc Anesth ; 33(7): 1877-1882, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30655200

RESUMO

OBJECTIVE: Extracorporeal cardiopulmonary resuscitation (eCPR) with venoarterial extracorporeal membrane oxygenation (VA-ECMO) is gaining importance as a rescue therapy for refractory cardiac arrest. VA-ECMO, especially in the setting of eCPR, is plagued by hemorrhagic and thromboembolic complications. The authors' aims were to describe the coagulation profile in refractory cardiac arrest and assess its prognostic role. DESIGN: Single-center retrospective study. SETTING: Cardiac surgical intensive care unit of a university hospital. PARTICIPANTS: One hundred eighty-eight patients treated with eCPR for intra-hospital and out-of-hospital refractory cardiac arrest, between 2008 and 2017. INTERVENTIONS: The authors retrospectively analyzed data from the first blood sample drawn during cannulation for VA-ECMO to understand the association of coagulation parameters with survival to hospital discharge, number of blood components transfused, anticoagulation therapy, serum lactate levels, no-flow time, and low-flow time. MEASUREMENTS AND MAIN RESULTS: Platelet count was 126 ± 79 × 109/L and in 17% of the population it was lower than 50 × 109/L, prothrombin time was 3.22 ± 4.01, activated partial thromboplastin time was 117 ± 78 seconds, fibrinogen was 186 ± 148 mg/dL, antithrombin was 47 ± 16%, and D-dimer was ≥2-fold the normal upper limit in 95% of patients. Fifty percent of patients had a disseminated intravascular coagulation (DIC) score ≥6 (52% among out-of-hospital cardiac arrest, 33% among in-hospital cardiac arrest), according to the criteria of the Japanese Society on Thrombosis and Hemostasis (2016). The median DIC score was 5.5 points (interquartile range 4-8), significantly different between survivors and nonsurvivors (4 [3-6] v 6 [4-8], p = 0.007). Every DIC score point contributed to the mortality risk (OR 1.34, 95% CI 1.09-1.67, p = 0.006). Patients with overt DIC less frequently received anticoagulants (28.6% v 55.9%, p = 0.002), started anticoagulant therapy later (12 [10-23] v 8.5 [5-12] hours, p = 0.045), and received a larger quantity of blood products (11 [4-23] v 3 [0-8.5] units, p < 0.0001). CONCLUSION: Coagulation derangements are frequent in patients with refractory cardiac arrest and have important consequences for eCPR management for anticoagulant therapy and blood product transfusion. The presence of DIC diagnostic criteria should be considered among the prognostic factors in this population of patients.

5.
J Cardiothorac Vasc Anesth ; 33(5): 1430-1439, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30600204

RESUMO

The authors aimed to identify interventions documented by randomized controlled trials (RCTs) that reduce mortality in adult critically ill and perioperative patients, followed by a survey of clinicians' opinions and routine practices to understand the clinicians' response to such evidence. The authors performed a comprehensive literature review to identify all topics reported to reduce mortality in perioperative and critical care settings according to at least 2 RCTs or to a multicenter RCT or to a single-center RCT plus guidelines. The authors generated position statements that were voted on online by physicians worldwide for agreement, use, and willingness to include in international guidelines. From 262 RCT manuscripts reporting mortality differences in the perioperative and critically ill settings, the authors selected 27 drugs, techniques, and strategies (66 RCTs, most frequently published by the New England Journal of Medicine [13 papers], Lancet [7], and Journal of the American Medical Association [5]) with an agreement ≥67% from over 250 physicians (46 countries). Noninvasive ventilation was the intervention supported by the largest number of RCTs (n = 13). The concordance between agreement and use (a positive answer both to "do you agree" and "do you use") showed differences between Western and other countries and between anesthesiologists and intensive care unit physicians. The authors identified 27 clinical interventions with randomized evidence of survival benefit and strong clinician support in support of their potential life-saving properties in perioperative and critically ill patients with noninvasive ventilation having the highest level of support. However, clinician views appear affected by specialty and geographical location.


Assuntos
Cuidados Críticos/métodos , Estado Terminal/mortalidade , Internet , Médicos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Inquéritos e Questionários , Cuidados Críticos/tendências , Estado Terminal/terapia , Humanos , Unidades de Terapia Intensiva/tendências , Internet/tendências , Mortalidade/tendências , Médicos/tendências
6.
J Am Heart Assoc ; 8(1): e011189, 2019 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-30590977

RESUMO

Background Mechanical chest compression (CC) is currently suggested to deliver sustained high-quality CC in a moving ambulance. This study compared the hemodynamic support provided by a mechanical piston device or manual CC during ambulance transport in a porcine model of cardiopulmonary resuscitation. Methods and Results In a simulated urban ambulance transport, 16 pigs in cardiac arrest were randomized to 18 minutes of mechanical CC with the LUCAS (n=8) or manual CC (n=8). ECG, arterial and right atrial pressure, together with end-tidal CO2 and transthoracic impedance curve were continuously recorded. Arterial lactate was assessed during cardiopulmonary resuscitation and after resuscitation. During the initial 3 minutes of cardiopulmonary resuscitation, the ambulance was stationary, while then proceeded along a predefined itinerary. When the ambulance was stationary, CC-generated hemodynamics were equivalent in the 2 groups. However, during ambulance transport, arterial and coronary perfusion pressure, and end-tidal CO2 were significantly higher with mechanical CC compared with manual CC (coronary perfusion pressure: 43±4 versus 18±4 mmHg; end-tidal CO2: 31±2 versus 19±2 mmHg, P<0.01 at 18 minutes). During cardiopulmonary resuscitation, arterial lactate was lower with mechanical CC compared with manual CC (6.6±0.4 versus 8.2±0.5 mmol/L, P<0.01). During transport, mechanical CC showed greater constancy compared with the manual CC, as represented by a higher CC fraction and a lower transthoracic impedance curve variability ( P<0.01). All animals in the mechanical CC group and 6 (75%) in the manual one were successfully resuscitated. Conclusions This model adds evidence in favor of the use of mechanical devices to provide ongoing high-quality CC and tissue perfusion during ambulance transport.

7.
J Cardiothorac Vasc Anesth ; 32(5): 2252-2260, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-29793761

RESUMO

OBJECTIVE: Corticosteroids have important effects on intermediate outcomes in critically ill patients, but their effect on survival is unknown. The objective of this meta-analysis was to analyze the effect on mortality of corticosteroids in critical and perioperative settings. DESIGN: A meta-analysis of randomized trials. SETTING: PubMed, Embase, BioMed Central, Google Scholar, and the Cochrane Central Register of Controlled Trials were searched to February 1, 2018, for randomized trials comparing corticosteroids with placebo or standard care. PARTICIPANTS: Critically ill or surgical adult patients. INTERVENTIONS: Corticosteroids compared with placebo or standard care. MEASUREMENTS AND MAIN RESULTS: A total of 44,553 patients from 135 studies were included. Overall, mortality in the corticosteroid group and in the control group were similar (16% v 16%; p = 0.9). Subanalyses identified a beneficial effect of corticosteroids on survival in patients with respiratory system diseases (9% v 13%; p < 0.001) and bacterial meningitis (28% v 32%; p= 0.04), and a detrimental effect on survival in patients with traumatic brain injury (22% v 19%; p < 0.001). No differences in mortality were found in patients with cardiac diseases (7% v 6%; p = 0.7), in patients undergoing cardiac surgery (2.8% v 3.2% p = 0.14), and when treatment duration or patient age were considered. CONCLUSIONS: This meta-analysis documents the safety of corticosteroids in the overall critically ill population with the notable exception of brain injury patients, a setting where the authors confirmed their detrimental effect on survival. A possible beneficial effect of corticosteroids on survival was found among patients with respiratory diseases and in patients with bacterial meningitis.

9.
Contemp Clin Trials ; 59: 38-43, 2017 08.
Artigo em Inglês | MEDLINE | ID: mdl-28533194

RESUMO

OBJECTIVE: There is initial evidence that the use of volatile anesthetics can reduce the postoperative release of cardiac troponin I, the need for inotropic support, and the number of patients requiring prolonged hospitalization following coronary artery bypass graft (CABG) surgery. Nevertheless, small randomized controlled trials have failed to demonstrate a survival advantage. Thus, whether volatile anesthetics improve the postoperative outcome of cardiac surgical patients remains uncertain. An adequately powered randomized controlled trial appears desirable. DESIGN: Single blinded, international, multicenter randomized controlled trial with 1:1 allocation ratio. SETTING: Tertiary and University hospitals. INTERVENTIONS: Patients (n=10,600) undergoing coronary artery bypass graft will be randomized to receive either volatile anesthetic as part of the anesthetic plan, or total intravenous anesthesia. MEASUREMENTS AND MAIN RESULTS: The primary end point of the study will be one-year mortality (any cause). Secondary endpoints will be 30-day mortality; 30-day death or non-fatal myocardial infarction (composite endpoint); cardiac mortality at 30day and at one year; incidence of hospital re-admission during the one year follow-up period and duration of intensive care unit, and hospital stay. The sample size is based on the hypothesis that volatile anesthetics will reduce 1-year unadjusted mortality from 3% to 2%, using a two-sided alpha error of 0.05, and a power of 0.9. CONCLUSIONS: The trial will determine whether the simple intervention of adding a volatile anesthetic, an intervention that can be implemented by all anesthesiologists, can improve one-year survival in patients undergoing coronary artery bypass graft surgery.


Assuntos
Anestesia em Procedimentos Cardíacos , Anestésicos Inalatórios , Ponte de Artéria Coronária , Doença da Artéria Coronariana/cirurgia , Complicações Pós-Operatórias , Adulto , Anestesia em Procedimentos Cardíacos/efeitos adversos , Anestesia em Procedimentos Cardíacos/métodos , Anestésicos Inalatórios/administração & dosagem , Anestésicos Inalatórios/química , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/métodos , Ponte de Artéria Coronária/mortalidade , Doença da Artéria Coronariana/mortalidade , Feminino , Humanos , Masculino , Avaliação de Processos e Resultados (Cuidados de Saúde) , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Análise de Sobrevida , Volatilização
10.
J Cardiothorac Vasc Anesth ; 31(2): 719-730, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27693206

RESUMO

OBJECTIVE: Of the 230 million patients undergoing major surgical procedures every year, more than 1 million will die within 30 days. Thus, any nonsurgical interventions that help reduce perioperative mortality might save thousands of lives. The authors have updated a previous consensus process to identify all the nonsurgical interventions, supported by randomized evidence, that may help reduce perioperative mortality. DESIGN AND SETTING: A web-based international consensus conference. PARTICIPANTS: The study comprised 500 clinicians from 61 countries. INTERVENTIONS: A systematic literature search was performed to identify published literature about nonsurgical interventions, supported by randomized evidence, showing a statistically significant impact on mortality. A consensus conference of experts discussed eligible papers. The interventions identified by the conference then were submitted to colleagues worldwide through a web-based survey. MEASUREMENTS AND MAIN RESULTS: The authors identified 11 interventions contributing to increased survival (perioperative hemodynamic optimization, neuraxial anesthesia, noninvasive ventilation, tranexamic acid, selective decontamination of the gastrointestinal tract, insulin for tight glycemic control, preoperative intra-aortic balloon pump, leuko-depleted red blood cells transfusion, levosimendan, volatile agents, and remote ischemic preconditioning) and 2 interventions showing increased mortality (beta-blocker therapy and aprotinin). Interventions then were voted on by participating clinicians. Percentages of agreement among clinicians in different countries differed significantly for 6 interventions, and a variable gap between evidence and clinical practice was noted. CONCLUSIONS: The authors identified 13 nonsurgical interventions that may decrease or increase perioperative mortality, with variable agreement by clinicians. Such interventions may be optimal candidates for investigation in high-quality trials and discussion in international guidelines to reduce perioperative mortality.


Assuntos
Consenso , Assistência Perioperatória/mortalidade , Assistência Perioperatória/métodos , Complicações Pós-Operatórias/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Congressos como Assunto , Humanos , Complicações Pós-Operatórias/prevenção & controle
12.
J Cardiothorac Vasc Anesth ; 31(2): 719-730, 2017.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: ses-34731

RESUMO

Objective: Out of the 230 million patients undergoing major surgical procedure every year, morethan 1 million will die within 30 days. Thus, any nonsurgical interventions that help reduce perioperative mortality might save thousands of lives. We decided to update a previous consensus process to identify all the nonsurgical interventions, supported by randomized evidence, that may help reduce perioperative mortality. Design and Setting: A web-based international consensus conference. Participants: 500 hundred clinicians from 61 countries. Interventions: A systematic literature search was performed to identify published literature aboutnonsurgical interventions, supported by randomized evidence showing a statistically significant impact on mortality. Eligible papers were discussed by a Consensus Conference of experts. The interventions identified by the conference were then submitted to colleagues worldwide through aweb-based survey...(AU)


Assuntos
Assistência Perioperatória , Mortalidade , Anestesia , Consenso , Cuidados Críticos
13.
Contemp Clin Trials ; 59: 38-43, 2017. tab
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: ses-37191

RESUMO

Objective: There is initial evidence that the use of volatile anesthetics can reduce the postoperative release of cardiac troponin I, the need for inotropic support, and the number of patients requiring prolonged hospitalization following coronary artery bypass graft (CABG) surgery. Nevertheless,small Randomized Controlled Trials have failed to demonstrate a survival advantage. Thus, whethervolatile anesthetics improve the postoperative outcome of cardiac surgical patients remains uncertain. An adequately powered randomized controlled trial appears desirable.Design: Single blinded, international, multicenter randomized controlled trial with 1:1 allocation ratio.Setting: Tertiary and University hospitals. (AU)


Assuntos
Humanos , Masculino , Feminino , Adulto , Anestesia , Mortalidade , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
14.
J Cardiothorac Vasc Anesth ; 31(2): 719-730, 2017.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: ses-37195

RESUMO

OBJECTIVE:Of the 230 million patients undergoing major surgical procedures every year, more than 1 million will die within 30 days. Thus, any nonsurgical interventions that help reduce perioperative mortality might save thousands of lives. The authors have updated a previous consensus process to identify all the nonsurgical interventions, supported by randomized evidence, that may help reduce perioperative mortality. (AU)


Assuntos
Humanos , Anestesia , Mortalidade
15.
J Cardiothorac Vasc Anesth ; 30(5): 1386-95, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-27499346

RESUMO

OBJECTIVES: Democracy-based medicine is a combination of evidence-based medicine (systematic review), expert assessment, and worldwide voting by physicians to express their opinions and self-reported practice via the Internet. The authors applied democracy-based medicine to key trials in critical care medicine. DESIGN AND SETTING: A systematic review of literature followed by web-based voting on findings of a consensus conference. PARTICIPANTS: A total of 555 clinicians from 61 countries. INTERVENTIONS: The authors performed a systematic literature review (via searching MEDLINE/PubMed, Scopus, and Embase) and selected all multicenter randomized clinical trials in critical care that reported a significant effect on survival and were endorsed by expert clinicians. Then they solicited voting and self-reported practice on such evidence via an interactive Internet questionnaire. Relationships among trial sample size, design, and respondents' agreement were investigated. The gap between agreement and use/avoidance and the influence of country origin on physicians' approach to interventions also were investigated. MEASUREMENTS AND MAIN RESULTS: According to 24 multicenter randomized controlled trials, 15 interventions affecting mortality were identified. Wide variabilities in both the level of agreement and reported practice among different interventions and countries were found. Moreover, agreement and reported practice often did not coincide. Finally, a positive correlation among agreement, trial sample size, and number of included centers was found. On the contrary, trial design did not influence clinicians' agreement. CONCLUSIONS: Physicians' clinical practice and agreement with the literature vary among different interventions and countries. The role of these interventions in affecting survival should be further investigated to reduce both the gap between evidence and clinical practice and transnational differences.


Assuntos
Cuidados Críticos/métodos , Medicina Baseada em Evidências/métodos , Mortalidade Hospitalar , Internacionalidade , Estudos Multicêntricos como Assunto/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Estado Terminal , Humanos , Médicos
16.
Dig Liver Dis ; 47(7): 566-71, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-25840875

RESUMO

BACKGROUND: Target Controlled Infusion is a sophisticated tool for providing optimal sedation regimen avoiding under or oversedation in gastrointestinal endoscopy. AIMS: To compare standard moderate sedation vs. non-anaesthesiologist-administered propofol sedation during gastrointestinal endoscopy. METHODS: Randomized controlled trial of 70 consecutive colonoscopies and 70 consecutive esophagogastroduodenoscopies (EGD). Standard group (n=70), received fentanyl (1 µg/kg)+midazolam (0.03-0.04 mg/kg) or midazolam only; propofol group (n=70), received fentanyl (1 µg/kg)+propofol Target Controlled Infusion (1.2-1.6 µg/ml) or propofol Target Controlled Infusion only. Discharge time, endoscopist satisfaction and patient satisfaction were recorded in all endoscopies. RESULTS: Colonoscopy: discharge time was significantly shorter in the propofol than the standard group (1.1 ± 0.3 vs. 5 ± 10.2 min, respectively; P=0.03). Endoscopist satisfaction was significantly higher (98.3 ± 11.4/100 vs. 87.2±12/100; P=0.001); patient satisfaction was significantly higher (95 ± 9.3/100 vs. 85.5 ± 14.4/100; P=0.002) in the propofol compared to the standard group. EGD: discharge time was not significantly different in the propofol and standard groups (1.1 ± 0.7 vs. 3.9 ± 9.2 min, respectively; P=0.146). Endoscopist satisfaction was significantly higher (92.7 ± 14.3/100 vs. 82.8 ± 21.2/100; P=0.03); patient satisfaction was significantly higher (93.8 ± 18.2/100 vs. 76.5 ± 25.2/100; P=0.003). In the propofol group 94.3% of patients vs. 71.4% of patients in standard group asked to receive the same sedation in the future (P=0.021). CONCLUSION: Target Controlled Infusion is a promising method for non-anaesthesiologist-administered propofol sedation.


Assuntos
Sedação Consciente/métodos , Endoscopia Gastrointestinal , Hipnóticos e Sedativos/administração & dosagem , Propofol/administração & dosagem , Adulto , Idoso , Método Duplo-Cego , Feminino , Fentanila/administração & dosagem , Humanos , Infusões Intravenosas , Tempo de Internação/estatística & dados numéricos , Masculino , Midazolam/administração & dosagem , Pessoa de Meia-Idade , Satisfação do Paciente
17.
Crit Care Med ; 43(8): 1559-68, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25821918

RESUMO

OBJECTIVES: We aimed to identify all treatments that affect mortality in adult critically ill patients in multicenter randomized controlled trials. We also evaluated the methodological aspects of these studies, and we surveyed clinicians' opinion and usual practice for the selected interventions. DATA SOURCES: MEDLINE/PubMed, Scopus, and Embase were searched. Further articles were suggested for inclusion from experts and cross-check of references. STUDY SELECTION: We selected the articles that fulfilled the following criteria: publication in a peer-reviewed journal; multicenter randomized controlled trial design; dealing with nonsurgical interventions in adult critically ill patients; and statistically significant effect in unadjusted landmark mortality. A consensus conference assessed all interventions and excluded those with lack of reproducibility, lack of generalizability, high probability of type I error, major baseline imbalances between intervention and control groups, major design flaws, contradiction by subsequent larger higher quality trials, modified intention to treat analysis, effect found only after adjustments, and lack of biological plausibility. DATA EXTRACTION: For all selected studies, we recorded the intervention and its comparator, the setting, the sample size, whether enrollment was completed or interrupted, the presence of blinding, the effect size, and the duration of follow-up. DATA SYNTHESIS: We found 15 interventions that affected mortality in 24 multicenter randomized controlled trials. Median sample size was small (199 patients) as was median centers number (10). Blinded trials enrolled significantly more patients and involved more centers. Multicenter randomized controlled trials showing harm also involved significantly more centers and more patients (p = 0.016 and p = 0.04, respectively). Five hundred fifty-five clinicians from 61 countries showed variable agreement on perceived validity of such interventions. CONCLUSIONS: We identified 15 treatments that decreased/increased mortality in critically ill patients in 24 multicenter randomized controlled trials. However, design affected trial size and larger trials were more likely to show harm. Finally, clinicians view of such trials and their translation into practice varied.


Assuntos
Cuidados Críticos/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Feminino , Fibrose/terapia , Humanos , Hipnóticos e Sedativos/administração & dosagem , Hipotermia Induzida/mortalidade , Masculino , Estudos Multicêntricos como Assunto , Decúbito Ventral , Reprodutibilidade dos Testes , Projetos de Pesquisa , Respiração Artificial/métodos , Respiração Artificial/mortalidade , Ácido Tranexâmico/sangue
19.
J Cardiothorac Vasc Anesth ; 27(6): 1108-13, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-23992652

RESUMO

OBJECTIVE: The authors measured cardiac index in unstable patients after cardiac surgery with the Pressure Recording Analytic Method (PRAM) and compared it with the reference method of thermodilution (ThD) with the pulmonary artery catheter; using the hypothesis that there were no significant differences between the 2 methods. DESIGN: A prospective study. SETTING: Cardiac surgery intensive care unit in a teaching hospital. PARTICIPANTS: Ninety-four measurements from 59 patients with ongoing high doses of inotropic drugs and/or an intra-aortic balloon pump for low-cardiac-output syndrome after cardiac surgery were studied. INTERVENTIONS: The pulmonary artery catheter and the radial or femoral arterial catheter for measuring blood pressure were already in place for standard hemodynamic monitoring. MEASUREMENTS AND MAIN RESULTS: The mean of the total CI measurements was 2.94 ± 0.67 L/min/m(2) with PRAM and 2.95 ± 0.63 L/min/m(2) with ThD, with no significant difference according to the linear mixed models analysis. The PRAM and ThD techniques were similar in unstable patients without atrial fibrillation (mean bias 0.047 ± 0.395 L/min/m(2) and a percentage error of 29%), while no agreement between PRAM and ThD was found in unstable patients with atrial fibrillation (mean bias 0.195 ± 0.885 L/min/m(2) and a percentage error of 69%). CONCLUSION: Cardiac index measurements after cardiac surgery performed with PRAM and with ThD showed a good agreement in hemodynamically unstable patients given high doses of inotropes and/or an IABP in patients in sinus rhythm, but not in those with atrial fibrillation.


Assuntos
Baixo Débito Cardíaco/diagnóstico , Débito Cardíaco/fisiologia , Procedimentos Cirúrgicos Cardíacos , Cuidados Críticos/métodos , Estado Terminal , Monitorização Fisiológica/métodos , Cuidados Pós-Operatórios/métodos , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/fisiopatologia , Pressão Sanguínea/fisiologia , Baixo Débito Cardíaco/complicações , Baixo Débito Cardíaco/terapia , Cardiotônicos/uso terapêutico , Eletrocardiografia , Feminino , Humanos , Masculino , Estudos Prospectivos , Reprodutibilidade dos Testes , Termodiluição
20.
J Cardiothorac Vasc Anesth ; 26(5): 764-72, 2012 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-22726656

RESUMO

OBJECTIVE: With more than 220 million major surgical procedures performed annually, perioperative interventions leading to even minor mortality reductions would save thousands of lives per year. This international consensus conference aimed to identify all nonsurgical interventions that increase or reduce perioperative mortality as suggested by randomized evidence. DESIGN AND SETTING: A web-based international consensus conference. PARTICIPANTS: More than 1,000 physicians from 77 countries participated in this web-based consensus conference. INTERVENTIONS: Systematic literature searches (MEDLINE/PubMed, June 8, 2011) were used to identify the papers with a statistically significant effect on mortality together with contacts with experts. Interventions were considered eligible for evaluation if they (1) were published in peer-reviewed journals, (2) dealt with a nonsurgical intervention (drug/technique/strategy) in adult patients undergoing surgery, and (3) provided a statistically significant mortality increase or reduction as suggested by a randomized trial or meta-analysis of randomized trials. MEASUREMENTS AND MAIN RESULTS: Fourteen interventions that might change perioperative mortality in adult surgery were identified. Interventions that might reduce mortality include chlorhexidine oral rinse, clonidine, insulin, intra-aortic balloon pump, leukodepletion, levosimendan, neuraxial anesthesia, noninvasive respiratory support, hemodynamic optimization, oxygen, selective decontamination of the digestive tract, and volatile anesthetics. In contrast, aprotinin and extended-release metoprolol might increase mortality. CONCLUSIONS: Future research and health care funding should be directed toward studying and evaluating these interventions.


Assuntos
Assistência Perioperatória/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto/mortalidade , Humanos , Internacionalidade , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
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