FILOMENA REGINA BARBOSA GOMES GALAS
Projetos de Pesquisa
Unidades Organizacionais
Departamento de Cirurgia, Faculdade de Medicina - Docente
Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/08 - Laboratório de Anestesiologia, Hospital das Clínicas, Faculdade de Medicina
Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/08 - Laboratório de Anestesiologia, Hospital das Clínicas, Faculdade de Medicina
14 resultados
Resultados de Busca
Agora exibindo 1 - 10 de 14
- 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 AbrahaoBackground: 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.
- 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 AbrahaoObjectives: 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.
- Liberal transfusion strategy improves survival in perioperative but not in critically ill patients. A meta-analysis of randomised trials(2015) FOMINSKIY, E.; PUTZU, A.; MONACO, F.; SCANDROGLIO, A. M.; KARASKOV, A.; GALAS, F. R. B. G.; HAJJAR, L. A.; ZANGRILLO, A.; LANDONI, G.Background: Guidelines support the use of a restrictive strategy in blood transfusion management in a variety of clinical settings. However, recent randomized controlled trials (RCTs) performed in the perioperative setting suggest a beneficial effect on survival of a liberal strategy. We aimed to assess the effect of liberal and restrictive blood transfusion strategies on mortality in perioperative and critically ill adult patients through a meta-analysis of RCTs. Methods: We searched PubMed/Medline, Embase, Cochrane Central Register of Controlled Trials, Transfusion Evidence Library, and Google Scholar up to 27 March 2015, for RCTs performed in perioperative or critically ill adult patients, receiving a restrictive or liberal transfusion strategy, and reporting all-cause mortality. We used a fixed or random-effects model to calculate the odds ratio (OR) and 95% confidence interval (CI) for pooled data. We assessed heterogeneity using Cochrane's Q and I-2 tests. The primary outcome was all-cause mortality within 90-day follow-up. Results: Patients in the perioperative period receiving a liberal transfusion strategy had lower all-cause mortality when compared with patients allocated to receive a restrictive transfusion strategy (OR 0.81; 95% CI 0.66-1.00; P=0.05; I-2=25%; Number needed to treat=97) with 7552 patients randomized in 17 trials. There was no difference in mortality among critically ill patients receiving a liberal transfusion strategy when compared with the restrictive transfusion strategy (OR 1.10; 95% CI 0.99-1.23; P=0.07; I-2=34%) with 3469 patients randomized in 10 trials. Conclusion: According to randomized published evidence, perioperative adult patients have an improved survival when receiving a liberal blood transfusion strategy.
- 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, GiovanniObjectives: 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.
- 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 AbrahaoObjective: 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.
- 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 AbrahaoBackgroundThe 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
- Nitric Oxide in Cardiac Surgery: A Meta-Analysis of Randomized Controlled Trials(2018) SARDO, Salvatore; OSAWA, Eduardo Atsushi; FINCO, Gabriele; GALAS, Filomena Regina Barbosa Gomes; ALMEIDA, Juliano Pinheiro de; CUTULI, Salvatore Lucio; FRASSANITO, Claudia; LANDONI, Giovanni; HAJJAR, Ludhmila AbrahaoObjectives: To investigate the efficacy and safety of perioperative administration of nitric oxide in cardiac surgery. Design: Meta-analysis of randomized controlled trials (RCTs). Participants: Cardiac surgery patients. Interventions: A search of Cochrane Central Register of Controlled Trials (CENTRAL), Embase, and MEDLINE for RCTs that compared nitric oxide with placebo or other comparators. Measurements and Main Results: The primary outcome was intensive care unit (ICU) stay, and secondary outcomes were mortality, duration of mechanical ventilation, and reduction of mean pulmonary artery pressure. The study included 18 RCTs comprising 958 patients. The authors calculated the pooled odds ratio (OR) and the mean difference (MD) with random-effects model. Quantitative synthesis of data demonstrated a clinically negligible reduction in the length of ICU stay (MD -0.38 days, confidence interval CI [-0.65 to -0.11]; p = 0.005) and mechanical ventilation duration (MD -4.81 hours, CI [-7.79 to -1.83]; p = 0.002) compared with all control interventions with no benefit on mortality. Conclusions: Perioperative delivery of inhaled nitric oxide resulted to be of no or minimal benefit in patients with pulmonary hypertension undergoing cardiac surgery. Large, randomized trials are needed to further assess its effect on major clinical outcomes and its cost-effectiveness.
- MortalitY in candIAc surgery (MYRIAD): A randomizeD controlled trial of volatile anesthetics. Rationale and design(2017) LANDONI, Giovanni; LOMIVOROTOV, Vladimir; PISANO, Antonio; NETO, Caetano Nigro; BENEDETTO, Umberto; ZOCCAI, Giuseppe Biondi; GEMMA, Marco; FRASSONI, Samuele; AGRO, Felice Eugenio; BAIOCCHI, Massimo; GALAS, Filomena R. Barbosa Gomes; BAUTIN, Andrei; BRADIC, Nikola; CAROLLO, Cristiana; CRESCENZI, Giuseppe; ELNAKERA, Abeer M.; EL-TAHAN, Mohamed R.; FOMINSKIY, Evgeny; FARAG, Ahmed G.; GAZIVODA, Gordana; GIANNI, Stefano; GRIGORYEV, Evgeny; GUARRACINO, Fabio; HANAFI, Sidik; HUANG, Weiqing; KUNST, Gudrun; KUNSTYR, Jan; LEI, Chong; LEMBO, Rosalba; LI, Zhi-jian; LIKHVANTSEV, Valery; LOZOVSKIY, Andrey; MA, Jun; MONACO, Fabrizio; NAVALESI, Paolo; NAZAR, Bukamal; PASYUGA, Vadim; PORTERI, Elena; ROYSE, Colin; RUGGERI, Laura; RIHA, Hynek; SILVA, Fernanda Santos; SEVERI, Luca; SHMYREV, Vladimir; UVALIEV, Nikolay; WANG, Cheng Bin; WANG, Chew-Yin; WINTERTON, Dario; YONG, Chow-Yen; YU, Jingui; BELLOMO, Rinaldo; ZANGRILLO, AlbertoObjective: 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 30 day 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.
- Intra-aortic balloon pump does not influence cerebral hemodynamics and neurological outcomes in high-risk cardiac patients undergoing cardiac surgery: an analysis of the IABCS trial(2019) CALDAS, Juliana R.; PANERAI, Ronney B.; BOR-SENG-SHU, Edson; FERREIRA, Graziela S. R.; CAMARA, Ligia; PASSOS, Rogerio H.; SALINET, Angela M.; AZEVEDO, Daniel S.; DE-LIMA-OLIVEIRA, Marcelo; GALAS, Filomena R. B. G.; FUKUSHIMA, Julia T.; NOGUEIRA, Ricardo; TACCONE, Fabio S.; LANDONI, Giovanni; ALMEIDA, Juliano P.; ROBINSON, Thompson G.; HAJJAR, Ludhmila A.Background The intra-aortic balloon pump (IABP) is often used in high-risk patients undergoing cardiac surgery to improve coronary perfusion and decrease afterload. The effects of the IABP on cerebral hemodynamics are unknown. We therefore assessed the effect of the IABP on cerebral hemodynamics and on neurological complications in patients undergoing cardiac surgery who were randomized to receive or not receive preoperative IABP in the 'Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery' (IABCS) trial. Methods This is a prospectively planned analysis of the previously published IABCS trial. Patients undergoing elective coronary artery bypass surgery with ventricular ejection fraction <= 40% or EuroSCORE >= 6 received preoperative IABP (n = 90) or no IABP (n = 91). Cerebral blood flow velocity (CBFV) of the middle cerebral artery through transcranial Doppler and blood pressure through Finometer or intra-arterial line were recorded preoperatively (T1) and 24 h (T2) and 7 days after surgery (T3) in patients with preoperative IABP (n = 34) and without IABP (n = 33). Cerebral autoregulation was assessed by the autoregulation index that was estimated from the CBFV response to a step change in blood pressure derived by transfer function analysis. Delirium, stroke and cognitive decline 6 months after surgery were recorded. Results There were no differences between the IABP and control patients in the autoregulation index (T1: 5.5 +/- 1.9 vs. 5.7 +/- 1.7; T2: 4.0 +/- 1.9 vs. 4.1 +/- 1.6; T3: 5.7 +/- 2.0 vs. 5.7 +/- 1.6, p = 0.97) or CBFV (T1: 57.3 +/- 19.4 vs. 59.3 +/- 11.8; T2: 74.0 +/- 21.6 vs. 74.7 +/- 17.5; T3: 71.1 +/- 21.3 vs. 68.1 +/- 15.1 cm/s; p = 0.952) at all time points. Groups were not different regarding postoperative rates of delirium (26.5% vs. 24.2%, p = 0.83), stroke (3.0% vs. 2.9%, p = 1.00) or cognitive decline through analysis of the Mini-Mental State Examination (16.7% vs. 40.7%; p = 0.07) and Montreal Cognitive Assessment (79.16% vs. 81.5%; p = 1.00). Conclusions The preoperative use of the IABP in high-risk patients undergoing cardiac surgery did not affect cerebral hemodynamics and was not associated with a higher incidence of neurological complications. Trial registration (NCT02143544).
- Liberal Versus Restrictive Transfusion Strategy in Critically Ill Oncologic Patients: The Transfusion Requirements in Critically Ill Oncologic Patients Randomized Controlled Trial(2017) BERGAMIN, Fabricio S.; ALMEIDA, Juliano P.; LANDONI, Giovanni; GALAS, Filomena R. B. G.; FUKUSHIMA, Julia T.; FOMINSKIY, Evgeny; PARK, Clarice H. L.; OSAWA, Eduardo A.; DIZ, Maria P. E.; OLIVEIRA, Gisele Q.; FRANCO, Rafael A.; NAKAMURA, Rosana E.; ALMEIDA, Elisangela M.; ABDALA, Edson; FREIRE, Maristela P.; FILHO, Roberto K.; AULER JR., Jose Otavio C.; HAJJAR, Ludhmila A.Objective: To assess whether a restrictive strategy of RBC transfusion reduces 28-day mortality when compared with a liberal strategy in cancer patients with septic shock. Design: Single center, randomized, double-blind controlled trial. Setting: Teaching hospital. Patients: Adult cancer patients with septic shock in the first 6 hours of ICU admission. Interventions: Patients were randomized to the liberal (hemoglobin threshold, < 9 g/dL) or to the restrictive strategy (hemoglobin threshold, < 7 g/dL) of RBC transfusion during ICU stay. Measurements and Main Results: Patients were randomized to the liberal (n = 149) or to the restrictive transfusion strategy (n = 151) group. Patients in the liberal group received more RBC units than patients in the restrictive group (1 [0-3] vs 0 [0-2] unit; p<0.001). At 28 days after randomization, mortality rate in the liberal group (primary endpoint of the study) was 45% (67 patients) versus 56% (84 patients) in the restrictive group (hazard ratio, 0.74; 95% CI, 0.53-1.04; p = 0.08) with no differences in ICU and hospital length of stay. At 90 days after randomization, mortality rate in the liberal group was lower (59% vs 70%) than in the restrictive group (hazard ratio, 0.72; 95% CI, 0.53-0.97; p = 0.03). Conclusions: We observed a survival trend favoring a liberal transfusion strategy in patients with septic shock when compared with the restrictive strategy. These results went in the opposite direction of the a priori hypothesis and of other trials in the field and need to be confirmed.