LUDHMILA ABRAHAO HAJJAR

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Departamento de Clínica Médica, Faculdade de Medicina - Docente
Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina
LIM/08 - Laboratório de Anestesiologia, Hospital das Clínicas, Faculdade de Medicina

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  • article 34 Citação(ões) na Scopus
    Current use of inotropes in circulatory shock
    (2021) SCHEEREN, Thomas W. L.; BAKKER, Jan; KAUFMANN, Thomas; ANNANE, Djillali; ASFAR, Pierre; BOERMA, E. Christiaan; CECCONI, Maurizio; CHEW, Michelle S.; CHOLLEY, Bernard; CRONHJORT, Maria; BACKER, Daniel De; DUBIN, Arnaldo; DUENSER, Martin W.; DURANTEAU, Jacques; GORDON, Anthony C.; HAJJAR, Ludhmila A.; HAMZAOUI, Olfa; HERNANDEZ, Glenn; EDUL, Vanina Kanoore; KOSTER, Geert; LANDONI, Giovanni; LEONE, Marc; LEVY, Bruno; MARTIN, Claude; MEBAZAA, Alexandre; MONNET, Xavier; MORELLI, Andrea; PAYEN, Didier; PEARSE, Rupert M.; PINSKY, Michael R.; RADERMACHER, Peter; REUTER, Daniel A.; SAKR, Yasser; SANDER, Michael; SAUGEL, Bernd; SINGER, Mervyn; SQUARA, Pierre; VIEILLARD-BARON, Antoine; VIGNON, Philippe; VINCENT, Jean-Louis; HORST, Iwan C. C. van der; VISTISEN, Simon T.; TEBOUL, Jean-Louis
    Background: Treatment decisions on critically ill patients with circulatory shock lack consensus. In an international survey, we aimed to evaluate the indications, current practice, and therapeutic goals of inotrope therapy in the treatment of patients with circulatory shock. Methods: From November 2016 to April 2017, an anonymous web-based survey on the use of cardiovascular drugs was accessible to members of the European Society of Intensive Care Medicine (ESICM). A total of 14 questions focused on the profile of respondents, the triggering factors, first-line choice, dosing, timing, targets, additional treatment strategy, and suggested effect of inotropes. In addition, a group of 42 international ESICM experts was asked to formulate recommendations for the use of inotropes based on 11 questions. Results: A total of 839 physicians from 82 countries responded. Dobutamine was the first-line inotrope in critically ill patients with acute heart failure for 84% of respondents. Two-thirds of respondents (66%) stated to use inotropes when there were persistent clinical signs of hypoperfusion or persistent hyperlactatemia despite a supposed adequate use of fluids and vasopressors, with (44%) or without (22%) the context of low left ventricular ejection fraction. Nearly half (44%) of respondents stated an adequate cardiac output as target for inotropic treatment. The experts agreed on 11 strong recommendations, all of which were based on excellent (> 90%) or good (81-90%) agreement. Recommendations include the indications for inotropes (septic and cardiogenic shock), the choice of drugs (dobutamine, not dopamine), the triggers (low cardiac output and clinical signs of hypoperfusion) and targets (adequate cardiac output) and stopping criteria (adverse effects and clinical improvement). Conclusion: Inotrope use in critically ill patients is quite heterogeneous as self-reported by individual caregivers. Eleven strong recommendations on the indications, choice, triggers and targets for the use of inotropes are given by international experts. Future studies should focus on consistent indications for inotrope use and implementation into a guideline for circulatory shock that encompasses individualized targets and outcomes.
  • article 8 Citação(ões) na Scopus
    Effect of postoperative goal-directed therapy in cancer patients undergoing high-risk surgery: a randomized clinical trial and meta-analysis
    (2018) GERENT, Aline Rejane Muller; ALMEIDA, Juliano Pinheiro; FOMINSKIY, Evgeny; LANDONI, Giovanni; OLIVEIRA, Gisele Queiroz de; RIZK, Stephanie Itala; FUKUSHIMA, Julia Tizue; SIMOES, Claudia Marques; RIBEIRO JR., Ulysses; PARK, Clarice Lee; NAKAMURA, Rosana Ely; FRANCO, Rafael Alves; CANDIDO, Patricia Ines; TAVARES, Cintia Rosa; CAMARA, Ligia; FERREIRA, Graziela dos Santos Rocha; ALMEIDA, Elisangela Pinto Marinho de; KALIL FILHO, Roberto; GALAS, Filomena Regina Barbosa Gomes; HAJJAR, Ludhmila Abrahao
    Background: Perioperative goal-directed hemodynamic therapy (GDHT) has been advocated in high-risk patients undergoing noncardiac surgery to reduce postoperative morbidity and mortality. We hypothesized that using cardiac index (CI)-guided GDHT in the postoperative period for patients undergoing high-risk surgery for cancer treatment would reduce 30-day mortality and postoperative complications. Methods: A randomized, parallel-group, superiority trial was performed in a tertiary oncology hospital. All adult patients undergoing high-risk cancer surgery who required intensive care unit admission were randomly allocated to a CI-guided GDHT group or to a usual care group. In the GDHT group, postoperative therapy aimed at CI >= 2.5 L/min/m(2) using fluids, inotropes and red blood cells during the first 8 postoperative hours. The primary outcome was a composite endpoint of 30-day all-cause mortality and severe postoperative complications during the hospital stay. A meta-analysis was also conducted including all randomized trials of postoperative GDHT published from 1966 to May 2017. Results: A total of 128 patients (64 in each group) were randomized. The primary outcome occurred in 34 patients of the GDHT group and in 28 patients of the usual care group (53.1% vs 43.8%, absolute difference 9.4 (95% CI, -7.8 to 25.8); p = 0.3). During the 8-h intervention period more patients in the GDHT group received dobutamine when compared to the usual care group (55% vs 16%, p < 0.001). A meta-analysis of nine randomized trials showed no differences in postoperative mortality (risk ratio 0.85, 95% CI 0.59-1.23; p = 0.4; p for heterogeneity = 0.7; I-2 = 0%) and in the overall complications rate (risk ratio 0.88, 95% CI 0.71-1.08; p = 0.2; p for heterogeneity = 0.07; I-2 = 48%), but a reduced hospital length of stay in the GDHT group (mean difference (MD) - 1.6; 95% CI - 2.75 to -0.46; p = 0.006; p for heterogeneity = 0.002; I-2 = 74%). Conclusions: CI-guided hemodynamic therapy in the first 8 postoperative hours does not reduce 30-day mortality and severe complications during hospital stay when compared to usual care in cancer patients undergoing high-risk surgery.
  • article 19 Citação(ões) na Scopus
    Effect of a Perioperative Intra-Aortic Balloon Pump in High-Risk Cardiac Surgery Patients: A Randomized Clinical Trial
    (2018) FERREIRA, Graziela Santos Rocha; ALMEIDA, Juliano Pinheiro de; LANDONI, Giovanni; VINCENT, Jean Louis; FOMINSKIY, Evgeny; GALAS, Filomena Regina Barbosa Gomes; GAIOTTO, Fabio A.; DALLAN, Luis Oliveira; FRANCO, Rafael Alves; LISBOA, Luiz Augusto; DALLAN, Luis Roberto Palma; FUKUSHIMA, Julia Tizue; RIZK, Stephanie Itala; PARK, Clarice Lee; STRABELLI, Tania Mara; LAGE, Silvia Helena Gelas; CAMARA, Ligia; ZEFERINO, Suely; JARDIM, Jaquelline; ARITA, Elisandra Cristina Trevisan Calvo; RIBEIRO, Juliana Caldas; AYUB-FERREIRA, Silvia Moreira; AULER JR., Jose Otavio Costa; KALIL FILHO, Roberto; JATENE, Fabio Biscegli; HAJJAR, Ludhmila Abrahao
    Objectives: The aim of this study was to evaluate the efficacy of perioperative intra-aortic balloon pump use in high-risk cardiac surgery patients. Design: A single-center randomized controlled trial and a meta-analysis of randomized controlled trials. Setting: Heart Institute of SAo Paulo University. Patients: High-risk patients undergoing elective coronary artery bypass surgery. Intervention: Patients were randomized to receive preskin incision intra-aortic balloon pump insertion after anesthesia induction versus no intra-aortic balloon pump use. Measurements and Main Results: The primary outcome was a composite endpoint of 30-day mortality and major morbidity (cardiogenic shock, stroke, acute renal failure, mediastinitis, prolonged mechanical ventilation, and a need for reoperation). A total of 181 patients (mean [sd] age 65.4 [9.4] yr; 32% female) were randomized. The primary outcome was observed in 43 patients (47.8%) in the intra-aortic balloon pump group and 42 patients (46.2%) in the control group (p = 0.46). The median duration of inotrope use (51hr [interquartile range, 32-94 hr] vs 39hr [interquartile range, 25-66 hr]; p = 0.007) and the ICU length of stay (5 d [interquartile range, 3-8 d] vs 4 d [interquartile range, 3-6 d]; p = 0.035) were longer in the intra-aortic balloon pump group than in the control group. A meta-analysis of 11 randomized controlled trials confirmed a lack of survival improvement in high-risk cardiac surgery patients with perioperative intra-aortic balloon pump use. Conclusions: In high-risk patients undergoing cardiac surgery, the perioperative use of an intra-aortic balloon pump did not reduce the occurrence of a composite outcome of 30-day mortality and major complications compared with usual care alone.
  • article 9 Citação(ões) na Scopus
    Effect of Volatile Anesthetics on Myocardial Infarction After Coronary Artery Surgery: A Post Hoc Analysis of a Randomized Trial
    (2022) ZANGRILLO, Alberto; LOMIVOROTOV, Vladimir V.; PASYUGA, Vadim V.; BELLETTI, Alessandro; GAZIVODA, Gordana; MONACO, Fabrizio; NETO, Caetano Nigro; LIKHVANTSEV, Valery V.; BRADIC, Nikola; LOZOVSKIY, Andrey; LEI, Chong; BUKAMAL, Nazar A. R.; SILVA, Fernanda Santos; BAUTIN, Andrey E.; MA, Jun; YONG, Chow Yen; CAROLLO, Cristiana; KUNSTYR, Jan; WANG, Chew Yin; V, Evgeny Grigoryev; RIHA, Hynek; WANG, Chengbin; EL-TAHAN, Mohamed R.; SCANDROGLIO, Anna Mara; MANSOR, Marzida; LEMBO, Rosalba; PONOMAREV, Dmitry N.; BEZERRA, Francisco Jose Lucena; RUGGERI, Laura; CHERNYAVSKIY, Alexander M.; XU, Junmei; TARASOV, Dmitry G.; NAVALESI, Paolo; YAVOROVSKIY, Andrey; BOVE, Tiziana; KUZOVLEV, Artem; HAJJAR, Ludhmila A.; LANDONI, Giovanni
    Objective: To investigate the effect of volatile anesthetics on the rates of postoperative myocardial infarction (MI) and cardiac death after coronary artery bypass graft (CABG). Design: A post hoc analysis of a randomized trial. Setting: Cardiac surgical operating rooms. Participants: Patients undergoing elective, isolated CABG. Interventions: Patients were randomized to receive a volatile anesthetic (desflurane, isoflurane, or sevoflurane) or total intravenous anesthesia (TIVA). The primary outcome was hemodynamically relevant MI (MI requiring high-dose inotropic support or prolonged intensive care unit stay) occurring within 48 hours from surgery. The secondary outcome was 1-year death due to cardiac causes. Measurements and Main Results: A total of 5,400 patients were enrolled between April 2014 and September 2017 (2,709 patients randomized to the volatile anesthetics group and 2,691 to TIVA). The mean age was 62 +/- 8.4 years, and the median baseline ejection fraction was 57% (50-67), without differences between the 2 groups. Patients in the volatile group had a lower incidence of MI with hemodynamic complications both in the per-protocol (14 of 2,530 [0.6%] v 27 of 2,501 [1.1%] in the TIVA group; p = 0.038) and as-treated analyses (16 of 2,708 [0.6%] v 29 of 2,617 [1.1%] in the TIVA group; p = 0.039), but not in the intention-to-treat analysis (17 of 2,663 [0.6%] v 28 of 2,667 [1.0%] in the TIVA group; p = 0.10). Overall, deaths due to cardiac causes were lower in the volatile group (23 of 2,685 [0.9%] v 40 of 2,668 [1.5%] than in the TIVA group; p = 0.03). Conclusions: An anesthetic regimen, including volatile agents, may be associated with a lower rate of postoperative MI with hemodynamic complication in patients undergoing CABG. Furthermore, it may reduce long-term cardiac mortality.
  • article 157 Citação(ões) na Scopus
    Volatile Anesthetics versus Total Intravenous Anesthesia for Cardiac Surgery
    (2019) LANDONI, Giovanni; LOMIVOROTOV, Vladimir V.; NETO, Caetano Nigro; MONACO, Fabrizio; PASYUGA, Vadim V.; BRADIC, Nikola; LEMBO, Rosalba; GAZIVODA, Gordana; LIKHVANTSEV, Valery V.; LEI, Chong; LOZOVSKIY, Andrey; TOMASSO, Nora Di; BUKAMAL, Nazar A. R.; SILVA, Fernanda S.; BAUTIN, Andrey E.; MA, Jun; CRIVELLARI, Martina; FARAG, Ahmed M. G. A.; UVALIEV, Nikolay S.; CAROLLO, Cristiana; PIERI, Marina; KUNSTYR, Jan; WANG, Chew Yin; BELLETTI, Alessandro; HAJJAR, Ludhmila A.; GRIGORYEV, Evgeny V.; AGRO, Felice E.; RIHA, Hynek; EL-TAHAN, Mohamed R.; SCANDROGLIO, A. Mara; ELNAKERA, Abeer M.; BAIOCCHI, Massimo; NAVALESI, Paolo; SHMYREV, Vladimir A.; SEVERI, Luca; HEGAZY, Mohammed A.; CRESCENZI, Giuseppe; PONOMAREV, Dmitry N.; BRAZZI, Luca; ARNONI, Renato; TARASOV, Dmitry G.; JOVIC, Miomir; CALABRO, Maria G.; BOVE, Tiziana; BELLOMO, Rinaldo; ZANGRILLO, Alberto
    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.
  • article 15 Citação(ões) na Scopus
    A Systematic Review and International Web-Based Survey of Randomized Controlled Trials in the Perioperative and Critical Care Setting: Interventions Reducing Mortality
    (2019) SARTINI, Chiara; LOMIVOROTOV, Vladimir; PIERI, Manna; LOPEZ-DELGADO, Juan Carlos; REDAELLI, Martina Baiardo; HAJJAR, Ludhmila; PISANO, Antonio; LIKHVANTSEV, Valery; FOMINSKIY, Evgeny; BRADIC, Nikola; CABRINI, Luca; NOVIKOV, Maxim; AVANCINI, Daniele; RIHA, Hynek; LEMBO, Rosalba; GAZIVODA, Gordana; PATERNOSTER, Gianluca; WANG, Chengbin; TAMA, Simona; ALVARO, Gabriele; WANG, Chew Yin; ROASIO, Agostino; RUGGERI, Laura; YONG, Chow-Yen; PASERO, Daniela; SEVERI, Luca; PASIN, Laura; MANCINO, Giuseppe; MURA, Paolo; MUSU, Mario; SPADARO, Savino; CONTE, Massimiliano; LOBREGLIO, Rosetta; SILVETTI, Simona; VOTTA, Carmine Domenico; BELLETTI, Alessandro; FRAJA, Diana Di; CORRADI, Francesco; BRUSASCO, Claudia; SAPORITO, Emanuela; D'AMICO, Alessandro; SARDO, Salvatore; ORTALDA, Alessandro; RIEFOLO, Claudio; FABRIZIO, Monaco; ZANGRILLO, Alberto; BELLOMO, Rinaldo; LANDONI, Giovanni
    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.
  • article 26 Citação(ões) na Scopus
    Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients: The VANCS II Randomized Clinical Trial*
    (2019) HAJJAR, Ludhmila Abrahao; ZAMBOLIM, Cristiane; BELLETTI, Alessandro; ALMEIDA, Juliano Pinheiro de; GORDON, Anthony C.; OLIVEIRA, Gisele; PARK, Clarice Hyesuk Lee; FUKUSHIMA, Julia Tizue; RIZK, Stephanie Itala; SZELES, Tais Felix; SANTOS NETO, Nestor Cordeiro dos; KALIL FILHO, Roberto; GALAS, Filomena Regina Barbosa Gomes; LANDONI, Giovanni
    Objectives: Previous trials suggest that vasopressin may improve outcomes in patients with vasodilatory shock. The aim of this study was to evaluate whether vasopressin could be superior to norepinephrine to improve outcomes in cancer patients with septic shock. Design: Single-center, randomized, double-blind clinical trial, and meta-analysis of randomized trials. Setting: ICU of a tertiary care hospital. Patients: Two-hundred fifty patients 18 years old or older with cancer and septic shock. Interventions: Patients were assigned to either vasopressin or norepinephrine as first-line vasopressor therapy. An updated meta-analysis was also conducted including randomized trials published until October 2018. Measurements and Main Results: The primary outcome was all-cause mortality at 28 days after randomization. Prespecified secondary outcomes included 90-days all-cause mortality rate; number of days alive and free of advanced organ support at day 28; and Sequential Organ Failure Assessment score 24 hours and 96 hours after randomization. We also measure the prevalence of adverse effects in 28 days. A total of 250 patients were randomized. The primary outcome was observed in 71 patients (56.8%) in the vasopressin group and 66 patients (52.8%) in the norepinephrine group (p = 0.52). There were no significant differences in 90-day mortality (90 patients [72.0%] and 94 patients [75.2%], respectively; p = 0.56), number of days alive and free of advanced organ support, adverse events, or Sequential Organ Failure Assessment score. Conclusions: In cancer patients with septic shock, vasopressin as first-line vasopressor therapy was not superior to norepinephrine in reducing 28-day mortality rate.
  • article 23 Citação(ões) na Scopus
    Lactated Ringer's Versus 4% Albumin on Lactated Ringer's in Early Sepsis Therapy in Cancer Patients: A Pilot Single-Center Randomized Trial
    (2019) PARK, Clarice Hyesuk Lee; ALMEIDA, Juliano Pinheiro de; OLIVEIRA, Gisele Queiroz de; RIZK, Stephanie Itala; FUKUSHIMA, Julia Tizue; NAKAMURA, Rosana Ely; MOURAO, Matheus Moraes; GALAS, Filomena Regina Barbosa Gomes; ABDALA, Edson; FREIRE, Maristela Pinheiro; KALIL FILHO, Roberto; JR, Jose Otavio Costa Auler; NARDELLI, Pasquale; MARTIN, Greg S.; LANDONI, Giovanni; HAJJAR, Ludhmila Abrahao
    Objective: To investigate the effects of the administration of 4% albumin on lactated Ringer's, when compared with lactated Ringer's alone, in the early phase of sepsis in cancer patients. Design: Single-center, randomized, double-blind, controlled-parallel trial. Setting: A tertiary care university cancer hospital. Patients: Cancer patients with severe sepsis or septic shock. Interventions: Between October 2014 and December 2016, patients were randomly assigned to receive either bolus of albumin in a lactated Ringer's solution or lactated Ringer's solution alone during the first 6 hours of fluid resuscitation after intensive care medicine (ICU) admission. Primary outcome was defined as death from any cause at 7 days. Secondary outcomes were defined as death from any cause within 28 days, change in Sequence Organ Failure Assessment scores from baseline to day 7, days alive and free of mechanical ventilation, days alive and free of vasopressor, renal replacement therapy during ICU stay, and length of ICU and hospital stay. Measurements and Main Results: A total of 360 patients were enrolled in the trial. At 7 days, 46 of 180 patients (26%) died in the albumin group and 40 of 180 (22%) died in the lactated Ringer's group (p = 0.5). At 28 days, 96 of 180 patients (53%) died in the albumin group and 83 of 180 (46%) died in the lactated Ringer's group (p = 0.2). No significant differences in secondary outcomes were observed. Conclusions: Adding albumin to early standard resuscitation with lactated Ringer's in cancer patients with sepsis did not improve 7-day survival.
  • article 4 Citação(ões) na Scopus
    Non-invAsive VentIlation for early General wArd respiraTory failurE (NAVIGATE): A multicenter randomized controlled study. Protocol and statistical analysis plan
    (2019) CABRINI, Luca; BRUSASCO, Claudia; ROASIO, Agostino; CORRADI, Francesco; NARDELLI, Pasquale; FILIPPINI, Matteo; COTTICELLI, Virginia; BELLETTI, Alessandro; FERRARA, Lorenzo; ANTONUCCI, Elio; REDAELLI, Martina Baiardo; LATTUADA, Marco; COLOMBO, Sergio; OLPER, Luigi; PONZETTA, Giuseppe; ANANIADOU, Sofia; MONTI, Giacomo; SEVERI, Luca; MAJ, Giulia; GIARDINA, Giuseppe; BIONDI-ZOCCAI, Giuseppe; BENEDETTO, Umberto; GEMMA, Marco; CAVALLERO, Sarah Sophia Michelle; HAJJAR, Ludhmila Abrahao; ZANGRILLO, Alberto; BELLOMO, Rinaldo; LANDONI, Giovanni
    Objective: Few randomized trials have evaluated the use of non-invasive ventilation (NIV) for early acute respiratory failure (ARF) in non-intensive care unit (ICU) wards. The aim of this study is to test the hypothesis that early NW for mild-moderate ARF in non-ICU wards can prevent development of severe ARF. Design: Pragmatic, parallel group, randomized, controlled, multicenter trial. Setting: Non-intensive care wards of tertiary centers. Patients: Non-KU ward patients with mild to moderate ARF without an established indication for NIV. Interventions: Patients will be randomized to receive or not receive NIV in addition to best available care. Measurements and main results: We will enroll 520 patients, 260 in each group. The primary endpoint of the study will be the development of severe ARF. Secondary endpoints will be 28-day mortality, length of hospital stay, safety of NW in non-ICU environments, and a composite endpoint of all in-hospital respiratory complications. Conclusions: This trial will help determine whether the early use of NW in non-ICU wards can prevent progression from mild-moderate ARF to severe ARF.
  • article 11 Citação(ões) na Scopus
    Dobutamine-sparing versus dobutamine-to-all strategy in cardiac surgery: a randomized noninferiority trial
    (2021) FRANCO, Rafael Alves; ALMEIDA, Juliano Pinheiro de; LANDONI, Giovanni; SCHEEREN, Thomas W. L.; GALAS, Filomena Regina Barbosa Gomes; FUKUSHIMA, Julia Tizue; ZEFFERINO, Suely; NARDELLI, Pasquale; PICCIONI, Marilde de Albuquerque; ARITA, Elisandra Cristina Trevisan Calvo; PARK, Clarice Hyesuk Lee; CUNHA, Ligia Cristina Camara; OLIVEIRA, Gisele Queiroz de; COSTA, Isabela Bispo Santos da Silva; KALIL FILHO, Roberto; JATENE, Fabio Biscegli; HAJJAR, Ludhmila Abrahao
    BackgroundThe detrimental effects of inotropes are well-known, and in many fields they are only used within a goal-directed therapy approach. Nevertheless, standard management in many centers includes administering inotropes to all patients undergoing cardiac surgery to prevent low cardiac output syndrome and its implications. Randomized evidence in favor of a patient-tailored, inotrope-sparing approach is still lacking. We designed a randomized controlled noninferiority trial in patients undergoing cardiac surgery with normal ejection fraction to assess whether an dobutamine-sparing strategy (in which the use of dobutamine was guided by hemodynamic evidence of low cardiac output associated with signs of inadequate tissue perfusion) was noninferior to an inotrope-to-all strategy (in which all patients received dobutamine).ResultsA total of 160 patients were randomized to the dobutamine-sparing strategy (80 patients) or to the dobutamine-to-all approach (80 patients). The primary composite endpoint of 30-day mortality or occurrence of major cardiovascular complications (arrhythmias, acute myocardial infarction, low cardiac output syndrome and stroke or transient ischemic attack) occurred in 25/80 (31%) patients of the dobutamine-sparing group (p=0.74) and 27/80 (34%) of the dobutamine-to-all group. There were no significant differences between groups regarding the incidence of acute kidney injury, prolonged mechanical ventilation, intensive care unit or hospital length of stay.DiscussionAlthough it is common practice in many centers to administer inotropes to all patients undergoing cardiac surgery, a dobutamine-sparing strategy did not result in an increase of mortality or occurrence of major cardiovascular events when compared to a dobutamine-to-all strategy. Further research is needed to assess if reducing the administration of inotropes can improve outcomes in cardiac surgery.Trial registration ClinicalTrials.gov, NCT02361801. Registered Feb 2nd, 2015. https://clinicaltrials.gov/ct2/show/NCT02361801