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1.
Artigo em Inglês | MEDLINE | ID: mdl-31072709

RESUMO

The first use of extracorporeal circulation in Italy occurred in 1951 in Turin. In the 1960s only 12 heart surgery centers were using extracorporeal circulation to treat patients, and health professionals had to complete their training abroad. During the last 50 years, Italian cardiac anesthesia has become a branch of major importance, and it has experienced a constantly growing number of active centers and professionals. Today, about 50,000 cardiac surgeries are performed every year in approximately 100 centers. Many results have been achieved during this period, thanks to the contribution of several pioneers. In this article, the history of Italian cardiac anesthesia and the role of Italian anesthesiologists in the development of this subspecialty in Italy and Europe are reviewed.

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.
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
4.
Turk J Anaesthesiol Reanim ; 46(3): 176-183, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30140512

RESUMO

Objective: Management of pain, agitation and delirium (PAD) remains to be a true challenge in critically ill patients. The pharmacological proprieties of dexmedetomidine (DEX) make it an ideal candidate drug for light and cooperative sedation, but many practical questions remain unanswered. This structured consensus from 17 intensivists well experienced on PAD management and DEX use provides indications for the appropriate use of DEX in clinical practice. Methods: A modified RAND/UCLA appropriateness method was used. In four predefined patient populations, the clinical scenarios do not properly cope by the current recommended pharmacological strategies (except DEX), and the possible advantages of DEX use were identified and voted for agreement, after reviewing literature data. Results: Three scenarios in medical patients, five scenarios in patients with acute respiratory failure undergoing non-invasive ventilation, three scenarios in patients with cardiac surgery in the early postoperative period and three scenarios in patients with overt delirium were identified as challenging with the current PAD strategies. In these scenarios, the use of DEX was voted as potentially useful by most of the panellists owing to its specific pharmacological characteristics, such as conservation of cognitive function, lack of effects on the respiratory drive, low induction of delirium and analgesia effects. Conclusion: DEX might be considered as a first-line sedative in different scenarios even though conclusive data on its benefits are still lacking.

5.
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.

6.
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
7.
J Cardiothorac Vasc Anesth ; 32(1): 225-235, 2018.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: ses-37196

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.(AU)


Assuntos
Período Perioperatório/mortalidade , Período Perioperatório/métodos
8.
Trials ; 18(1): 264, 2017 06 07.
Artigo em Inglês | MEDLINE | ID: mdl-28592276

RESUMO

BACKGROUND: There is no consensus on which lung-protective strategies should be used in cardiac surgery patients. Sparse and small randomized clinical and animal trials suggest that maintaining mechanical ventilation during cardiopulmonary bypass is protective on the lungs. Unfortunately, such evidence is weak as it comes from surrogate and minor clinical endpoints mainly limited to elective coronary surgery. According to the available data in the academic literature, an unquestionable standardized strategy of lung protection during cardiopulmonary bypass cannot be recommended. The purpose of the CPBVENT study is to investigate the effectiveness of different strategies of mechanical ventilation during cardiopulmonary bypass on postoperative pulmonary function and complications. METHODS/DESIGN: The CPBVENT study is a single-blind, multicenter, randomized controlled trial. We are going to enroll 870 patients undergoing elective cardiac surgery with planned use of cardiopulmonary bypass. Patients will be randomized into three groups: (1) no mechanical ventilation during cardiopulmonary bypass, (2) continuous positive airway pressure of 5 cmH2O during cardiopulmonary bypass, (3) respiratory rate of 5 acts/min with a tidal volume of 2-3 ml/Kg of ideal body weight and positive end-expiratory pressure of 3-5 cmH2O during cardiopulmonary bypass. The primary endpoint will be the incidence of a PaO2/FiO2 ratio <200 until the time of discharge from the intensive care unit. The secondary endpoints will be the incidence of postoperative pulmonary complications and 30-day mortality. Patients will be followed-up for 12 months after the date of randomization. DISCUSSION: The CPBVENT trial will establish whether, and how, different ventilator strategies during cardiopulmonary bypass will have an impact on postoperative pulmonary complications and outcomes of patients undergoing cardiac surgery. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02090205 . Registered on 8 March 2014.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Ponte Cardiopulmonar , Respiração Artificial/métodos , Ponte Cardiopulmonar/efeitos adversos , Protocolos Clínicos , Humanos , Itália , Pulmão/fisiopatologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/fisiopatologia , Projetos de Pesquisa , Respiração Artificial/efeitos adversos , Mecânica Respiratória , Fatores de Risco , Método Simples-Cego , Fatores de Tempo , Resultado do Tratamento
9.
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
10.
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
11.
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
12.
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
13.
Am Heart J ; 177: 66-73, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27297851

RESUMO

OBJECTIVE: Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes. DESIGN: Double-blind, placebo-controlled, multicenter randomized trial. SETTING: Tertiary care hospitals. INTERVENTIONS: Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 µg/[kg min]) or placebo for 24-48 hours. MEASUREMENTS AND MAIN RESULTS: The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction. CONCLUSIONS: This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery.


Assuntos
Baixo Débito Cardíaco/terapia , Cardiotônicos/uso terapêutico , Hidrazonas/uso terapêutico , Balão Intra-Aórtico , Complicações Pós-Operatórias/terapia , Piridazinas/uso terapêutico , Lesão Renal Aguda/epidemiologia , Baixo Débito Cardíaco/mortalidade , Procedimentos Cirúrgicos Cardíacos/mortalidade , Método Duplo-Cego , Humanos , Infusões Intravenosas , Unidades de Terapia Intensiva , Tempo de Internação/estatística & dados numéricos , Complicações Pós-Operatórias/mortalidade , Respiração Artificial , Simendana
15.
Heart Lung Vessel ; 7(1): 35-46, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25861589

RESUMO

INTRODUCTION: The incidence of Acute Kidney Injury is nowadays high in critically ill patients. Its etiology is multifactorial and a primary role is played by low cardiac output syndrome. Everything targeted to normalize cardiac output should increase the renal perfusion and abolish the secondary vasoconstriction. Levosimendan is a calcium sensitizer drug with inotropic properties that improves cardiac output and seems to increase renal blood flow. The aim of this meta-analysis was to evaluate the role of levosimendan in critically ill patients with or at risk of Acute Kidney Injury. METHODS: We performed a meta-analysis of  randomized controlled trials searching for trials that compared levosimendan with any comparator. The endpoints were the number of patients receiving Renal Replacement Therapy after randomization and the number of patients developing Acute Kidney Injury. RESULTS: Final analysis included 33 trials and 3,879 patients (2,024 levosimendan and 1,855 control). The overall analysis showed that the use of levosimendan was associated with a significant reduction in the risk of Renal Replacement Therapy (17 of 492 [3.5%] in the levosimendan group versus 37 of 427 [8.7%] in the control group, relative risk =0.52 [0.32 to 0.86], p for effect =0.01) and of Acute Kidney Injury (114 of 1,598 [7.1%] in the levosimendan group versus 143 of 1,529 [9.4%] in the control arm, relative risk =0.79 [0.63 to 0.99], p for effect =0.048). CONCLUSIONS: This meta-analysis suggests that the use of levosimendan is associated with a significant reduction of Renal Replacement Therapy in critically ill patients.

16.
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
17.
Heart, Lung and Vessels ; 07(01): 35-46, 2015. ilus
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: ses-31188

RESUMO

The incidence of Acute Kidney Injury is nowadays high in critically ill patients. Its etiology ismultifactorial and a primary role is played by low cardiac output syndrome. Everything targeted to normalizecardiac output should increase the renal perfusion and abolish the secondary vasoconstriction. Levosimendanis a calcium sensitizer drug with inotropic properties that improves cardiac output and seems to increase renalblood flow. The aim of this meta-analysis was to evaluate the role of levosimendan in critically ill patients withor at risk of Acute Kidney Injury.Methods: We performed a meta-analysis of randomized controlled trials searching for trials that comparedlevosimendan with any comparator. The endpoints were the number of patients receiving Renal ReplacementTherapy after randomization and the number of patients developing Acute Kidney Injury.Results: Final analysis included 33 trials and 3,879 patients (2,024 levosimendan and 1,855 control). Theoverall analysis showed that the use of levosimendan was associated with a significant reduction in the riskof Renal Replacement Therapy (17 of 492 [3.5%] in the levosimendan group versus 37 of 427 [8.7%] in thecontrol group, relative risk =0.52 [0.32 to 0.86], p for effect =0.01) and of Acute Kidney Injury (114 of 1,598[7.1%] in the levosimendan group versus 143 of 1,529 [9.4%] in the control arm, relative risk =0.79 [0.63 to0.99], p for effect =0.048).Conclusions: This meta-analysis suggests that the use of levosimendan is associated with a significant reductionof Renal Replacement Therapy in critically ill patients. (AU)


Assuntos
Lesão Renal Aguda , Cuidados Críticos , Terapia de Substituição Renal
18.
JAMA ; 312(21): 2244-53, 2014 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-25265449

RESUMO

IMPORTANCE: No effective pharmaceutical agents have yet been identified to treat acute kidney injury after cardiac surgery. OBJECTIVE: To determine whether fenoldopam reduces the need for renal replacement therapy in critically ill cardiac surgery patients with acute kidney injury. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized, double-blind, placebo-controlled, parallel-group study from March 2008 to April 2013 in 19 cardiovascular intensive care units in Italy. We randomly assigned 667 patients admitted to intensive care units after cardiac surgery with early acute kidney injury (≥50% increase of serum creatinine level from baseline or oliguria for ≥6 hours) to receive fenoldopam (338 patients) or placebo (329 patients). We used a computer-generated permuted block randomization sequence for treatment allocation. All patients completed their follow-up 30 days after surgery, and data were analyzed according to the intention-to-treat principle. INTERVENTIONS: Continuous infusion of fenoldopam or placebo for up to 4 days with a starting dose of 0.1 µg/kg/min (range, 0.025-0.3 µg/kg/min). MAIN OUTCOMES AND MEASURES: The primary end point was the rate of renal replacement therapy. Secondary end points included mortality (intensive care unit and 30-day mortality) and the rate of hypotension during study drug infusion. RESULTS: The study was stopped for futility as recommended by the safety committee after a planned interim analysis. Sixty-nine of 338 patients (20%) allocated to the fenoldopam group and 60 of 329 patients (18%) allocated to the placebo group received renal replacement therapy (P = .47). Mortality at 30 days was 78 of 338 (23%) in the fenoldopam group and 74 of 329 (22%) in the placebo group (P = .86). Hypotension occurred in 85 (26%) patients in the fenoldopam group and in 49 (15%) patients in the placebo group (P = .001). CONCLUSIONS AND RELEVANCE: Among patients with acute kidney injury after cardiac surgery, fenoldopam infusion, compared with placebo, did not reduce the need for renal replacement therapy or risk of 30-day mortality but was associated with an increased rate of hypotension. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00621790.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Fenoldopam/uso terapêutico , Terapia de Substituição Renal/métodos , Vasodilatadores/uso terapêutico , Lesão Renal Aguda , Idoso , Creatinina , Estado Terminal , Método Duplo-Cego , Feminino , Fenoldopam/efeitos adversos , Humanos , Hipotensão/induzido quimicamente , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Estados Unidos , Vasodilatadores/efeitos adversos
19.
Blood Purif ; 37(1): 27-32, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24481286

RESUMO

BACKGROUND/AIMS: Cardiopulmonary bypass (CPB) has been thought to promote endotoxin translocation from the gut. Increased endotoxin activity (EA) has been related to a worsening of organ dysfunction, particularly acute kidney injury (AKI). This study aims to determine if CPB could influence EA after cardiac surgery, and if EA variations are associated with renal dysfunction following CPB. METHODS: This was an observational study of patients subjected to complex cardiac surgery, likely to last for >120 min. Blood samples were obtained before, during and after CPB for EA analysis. AKI occurrence defined by the Acute Kidney Injury Network criteria was evaluated. RESULTS: Eighteen patients were enrolled. EA significantly increased after 12 h following CPB. Variations of EA from baseline were significantly associated with variations of creatinine, i.e. AKI. CONCLUSION: Complex cardiac surgery requiring long CPB promotes EA increases that could be associated with variations of serum creatinine and AKI occurrence.


Assuntos
Lesão Renal Aguda/sangue , Ponte Cardiopulmonar/efeitos adversos , Endotoxinas/sangue , Idoso , Creatinina/sangue , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Cirurgia Torácica
20.
J Cardiothorac Vasc Anesth ; 27(6): 1384-98, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24103711

RESUMO

OBJECTIVE: To identify all interventions that increase or reduce mortality in patients with acute kidney injury (AKI) and to establish the agreement between stated beliefs and actual practice in this setting. DESIGN AND SETTING: Systematic literature review and international web-based survey. PARTICIPANTS: More than 300 physicians from 62 countries. INTERVENTIONS: Several databases, including MEDLINE/PubMed, were searched with no time limits (updated February 14, 2012) to identify all the drugs/techniques/strategies that fulfilled all the following criteria: (a) published in a peer-reviewed journal, (b) dealing with critically ill adult patients with or at risk for acute kidney injury, and (c) reporting a statistically significant reduction or increase in mortality. MEASUREMENTS AND MAIN RESULTS: Of the 18 identified interventions, 15 reduced mortality and 3 increased mortality. Perioperative hemodynamic optimization, albumin in cirrhotic patients, terlipressin for hepatorenal syndrome type 1, human immunoglobulin, peri-angiography hemofiltration, fenoldopam, plasma exchange in multiple-myeloma-associated AKI, increased intensity of renal replacement therapy (RRT), CVVH in severely burned patients, vasopressin in septic shock, furosemide by continuous infusion, citrate in continuous RRT, N-acetylcysteine, continuous and early RRT might reduce mortality in critically ill patients with or at risk for AKI; positive fluid balance, hydroxyethyl starch and loop diuretics might increase mortality in critically ill patients with or at risk for AKI. Web-based opinion differed from consensus opinion for 30% of interventions and self-reported practice for 3 interventions. CONCLUSION: The authors identified all interventions with at least 1 study suggesting a significant effect on mortality in patients with or at risk of AKI and found that there is discordance between participant stated beliefs and actual practice regarding these topics.


Assuntos
Lesão Renal Aguda/prevenção & controle , Lesão Renal Aguda/terapia , Lesão Renal Aguda/mortalidade , Comorbidade , Pesquisas sobre Serviços de Saúde , Hemodinâmica , Humanos , Internet , Monitorização Intraoperatória , Assistência Perioperatória
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