Lactated Ringer's Versus 4% Albumin on Lactated Ringer's in Early Sepsis Therapy in Cancer Patients: A Pilot Single-Center Randomized Trial.

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.

Effect of postoperative goal-directed therapy in cancer patients undergoing high-risk surgery: a randomized clinical trial and meta-analysis.

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/m2 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; I2 = 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; I2 = 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; I2 = 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. TRIAL REGISTRATION: www.clinicaltrials.gov , NCT01946269 . Registered on 16 September 2013.

Vasopressin versus Norepinephrine in Patients with Vasoplegic Shock after Cardiac Surgery: The VANCS Randomized Controlled Trial.

BACKGROUND: Vasoplegic syndrome is a common complication after cardiac surgery and impacts negatively on patient outcomes. The objective of this study was to evaluate whether vasopressin is superior to norepinephrine in reducing postoperative complications in patients with vasoplegic syndrome. METHODS: This prospective, randomized, double-blind trial was conducted at the Heart Institute, University of Sao Paulo, Sao Paulo, Brazil, between January 2012 and March 2014. Patients with vasoplegic shock (defined as mean arterial pressure less than 65 mmHg resistant to fluid challenge and cardiac index greater than 2.2 l · min · m) after cardiac surgery were randomized to receive vasopressin (0.01 to 0.06 U/min) or norepinephrine (10 to 60 µg/min) to maintain arterial pressure. The primary endpoint was a composite of mortality or severe complications (stroke, requirement for mechanical ventilation for longer than 48 h, deep sternal wound infection, reoperation, or acute renal failure) within 30 days. RESULTS: A total of 330 patients were randomized, and 300 were infused with one of the study drugs (vasopressin, 149; norepinephrine, 151). The primary outcome occurred in 32% of the vasopressin patients and in 49% of the norepinephrine patients (unadjusted hazard ratio, 0.55; 95% CI, 0.38 to 0.80; P = 0.0014). Regarding adverse events, the authors found a lower occurrence of atrial fibrillation in the vasopressin group (63.8% vs. 82.1%; P = 0.0004) and no difference between groups in the rates of digital ischemia, mesenteric ischemia, hyponatremia, and myocardial infarction. CONCLUSIONS: The authors' results suggest that vasopressin can be used as a first-line vasopressor agent in postcardiac surgery vasoplegic shock and improves clinical outcomes.

Transfusion requirements in surgical oncology patients: a prospective, randomized controlled trial.

BACKGROUND: Several studies have indicated that a restrictive erythrocyte transfusion strategy is as safe as a liberal one in critically ill patients, but there is no clear evidence to support the superiority of any perioperative transfusion strategy in patients with cancer. METHODS: In a randomized, controlled, parallel-group, double-blind (patients and outcome assessors) superiority trial in the intensive care unit of a tertiary oncology hospital, the authors evaluated whether a restrictive strategy of erythrocyte transfusion (transfusion when hemoglobin concentration <7 g/dl) was superior to a liberal one (transfusion when hemoglobin concentration <9 g/dl) for reducing mortality and severe clinical complications among patients having major cancer surgery. All adult patients with cancer having major abdominal surgery who required postoperative intensive care were included and randomly allocated to treatment with the liberal or the restrictive erythrocyte transfusion strategy. The primary outcome was a composite endpoint of mortality and morbidity. RESULTS: A total of 198 patients were included as follows: 101 in the restrictive group and 97 in the liberal group. The primary composite endpoint occurred in 19.6% (95% CI, 12.9 to 28.6%) of patients in the liberal-strategy group and in 35.6% (27.0 to 45.4%) of patients in the restrictive-strategy group (P = 0.012). Compared with the restrictive strategy, the liberal transfusion strategy was associated with an absolute risk reduction for the composite outcome of 16% (3.8 to 28.2%) and a number needed to treat of 6.2 (3.5 to 26.5). CONCLUSION: A liberal erythrocyte transfusion strategy with a hemoglobin trigger of 9 g/dl was associated with fewer major postoperative complications in patients having major cancer surgery compared with a restrictive strategy.

A liberal strategy of red blood cell transfusion reduces cardiogenic shock in elderly patients undergoing cardiac surgery.

OBJECTIVE: The aim of this study was to compare outcomes in patients undergoing cardiac surgery who are aged 60 years or more or less than 60 years after implementation of a restrictive or a liberal transfusion strategy. METHODS: This is a substudy of the Transfusion Requirements After Cardiac Surgery (TRACS) randomized controlled trial. In this subgroup analysis, we separated patients into those aged 60 years or more (elderly) and those aged less than 60 years randomized to a restrictive or a liberal strategy of red blood cell transfusion. The primary outcome was a composite defined as a combination of 30-day all-cause mortality and severe morbidity. RESULTS: Of the 502 patients included in the Transfusion Requirements After Cardiac Surgery study, 260 (51.8%) were aged 60 years or more and 242 (48.2%) were aged less than 60 years and were included in this study. The primary end point occurred in 11.9% of patients in the liberal strategy group and 16.8% of patients in the restrictive strategy group (P = .254) for those aged 60 years or more and in 6.8% of patients in the liberal strategy group and 5.6% of patients in the restrictive strategy group for those aged less than 60 years (P = .714). However, in the older patients, cardiogenic shock was more frequent in patients in the restrictive transfusion group (12.8% vs 5.2%, P = .031). Thirty-day mortality, acute respiratory distress syndrome, and acute renal injury were similar in the restrictive and liberal transfusion groups in both age groups. CONCLUSIONS: Although there was no difference between groups regarding the primary outcome, a restrictive transfusion strategy may result in an increased rate of cardiogenic shock in elderly patients undergoing cardiac surgery compared with a more liberal strategy. Cardiovascular risk of anemia may be more harmful than the risk of blood transfusion in older patients.

Volume replacement therapy during hip arthroplasty using hydroxyethyl starch (130/0.4) compared to lactated Ringer decreases allogeneic blood transfusion and postoperative infection.

BACKGROUND AND OBJECTIVES: Hydroxyethyl starch (HES) 130/0.4 is considered an effective plasma expander when compared to crystalloids. There is controversy around its superiority regarding hemodynamic optimization and about possible detrimental effects on coagulation. The aim of this study was to compare the effects of HES 130/0.4 to lactated Ringer solution during hip arthroplasty in adult patients under spinal anesthesia regarding intraoperative bleeding, hemodynamic parameters, coagulation profile, transfusion requirements and clinical outcomes. METHODS: In this randomized, controlled trial, 48 patients scheduled for hip arthroplasty with spinal anesthesia were randomized into two groups: 24 patients were allocated to receive a preload of 15 mL.kg(-1) of HES 130/0.4 and 24 patients received a preload of 30 mL.kg(-1) lactated Ringer solution before surgery. Hemodynamic measurements, hemoglobin concentrations, biochemical parameters and coagulation tests were evaluated in three periods during surgical procedure. Patients received medical follow-up during their hospital stay and up to postoperative 30 days. Primary outcome was the requirement of red blood cell transfusion between groups during hospital stay. Secondary outcome were hemodynamic parameters, length of hospital stay, mortality and occurrence of clinical postoperative complications. RESULTS: Red blood cell transfusion was required in 17% of patients in the HES group and in 46% in the Ringer group (p = .029). Postoperative infections were more frequently observed in the Ringer group (17%) compared to the HES group (0), p = .037. There were no significant differences between groups in mortality, hospital length of stay and clinical complications other than infection. CONCLUSIONS: During hip arthroplasty, patients treated with hypervolemic hemodilution with hydroxyethyl starch 130/0.4 required less transfusion and presented lower infection rate compared to patients who received lactated Ringer.

Volume replacement therapy during hip arthroplasty using hydroxyethyl starch (130/0.4) compared to lactated Ringer decreases allogeneic blood transfusion and postoperative infection.

BACKGROUND AND OBJECTIVES: Hydroxyethyl starch (HES) 130/0.4 is considered an effective plasma expander when compared to crystalloids. There is controversy around its superiority regarding hemodynamic optimization and about possible detrimental effects on coagulation. The aim of this study was to compare the effects of HES 130/0.4 to lactated Ringer solution during hip arthroplasty in adult patients under spinal anesthesia regarding intraoperative bleeding, hemodynamic parameters, coagulation profile, transfusion requirements and clinical outcomes. METHODS: In this randomized, controlled trial, 48 patients scheduled for hip arthroplasty with spinal anesthesia were randomized into two groups: 24 patients were allocated to receive a preload of 15 mL.kg(-1) of HES 130/0.4 and 24 patients received a preload of 30 mL.kg(-1) lactated Ringer solution before surgery. Hemodynamic measurements, hemoglobin concentrations, biochemical parameters and coagulation tests were evaluated in three periods during surgical procedure. Patients received medical follow-up during their hospital stay and up to postoperative 30 days. Primary outcome was the requirement of red blood cell transfusion between groups during hospital stay. Secondary outcome were hemodynamic parameters, length of hospital stay, mortality and occurrence of clinical postoperative complications. RESULTS: Red blood cell transfusion was required in 17% of patients in the HES group and in 46% in the Ringer group (p = .029). Postoperative infections were more frequently observed in the Ringer group (17%) compared to the HES group (0), p = .037. There were no significant differences between groups in mortality, hospital length of stay and clinical complications other than infection. CONCLUSIONS: During hip arthroplasty, patients treated with hypervolemic hemodilution with hydroxyethyl starch 130/0.4 required less transfusion and presented lower infection rate compared to patients who received lactated Ringer.

Lactate and base deficit are predictors of mortality in critically ill patients with cancer.

OBJECTIVE: Cancer patients frequently require admission to intensive care unit. However, there are a few data regarding predictive factors for mortality in this group of patients. The aim of this study was to evaluate whether arterial lactate or standard base deficit on admission and after 24 hours can predict mortality for patients with cancer. METHODS: We evaluated 1,129 patients with severe sepsis, septic shock, or postoperative after high-risk surgery. Lactate and standard base deficit collected at admission and after 24 hours were compared between survivors and non-survivors. We evaluated whether these perfusion markers are independent predictors of mortality. RESULTS: There were 854 hospital survivors (76.5%). 24 h lactate > 1.9 mmol/L and standard base deficit < -2.3 were independent predictors of intensive care unit mortality. 24 h lactate >1.9 mmol/L and 24 h standard base deficit < -2.3 mmol/Lwere independent predictors of hospital death. CONCLUSION: Our findings suggest that lactate and standard base deficit measurement should be included in the routine assessment of patients with cancer admitted to the intensive care unit with sepsis, septic shock or after high-risk surgery. These markers may be useful in the adequate allocation of resources in this population.

Terapia de reposição volêmica durante artroplastia de quadril usando hidroxietilamido (130/0, 4) comparado com Ringer lactato diminui transfusão de sangue alogênico e infecção pós-operatória / Volume replacement therapy during hip arthroplasty using hydroxyethyl starch (130/0. 4) compared to lactated Ringer decreases allogeneic blood transfusion and postoperative infection / Terapia de reposición volémica durante la artroplastia de cadera usando hidroxietilalmidón (130/0, 4): comparado con lactato de Ringer reduce la transfusión de sangre alogénica y la infección posoperatoria

JUSTIFICATIVA E OBJETIVOS: O hidroxietilamido 130/0,4 (HES 130/0,4) é considerado um expansor plasmático efetivo quando comparado com cristaloides. Há controvérsia sobre sua superioridade em relação à otimização hemodinâmica e sobre possíveis efeitos prejudiciais na coagulação. O objetivo deste estudo foi comparar os efeitos do HES 130/0,4 com os da solução de Ringer lactato durante artroplastia de quadril em pacientes adultos sob raquianestesia e levou em consideração sangramento intraoperatório, parâmetros hemodinâmicos, coagulograma, necessidade de transfusão e desfechos clínicos. MÉTODOS: Neste estudo randômico e controlado, 48 pacientes agendados para artroplastia de quadril com raquianestesia foram alocados em dois grupos: 24 receberam uma pré-carga de HES 130/0,4 (15 mL.kg-1) e 24 receberam uma pré-carga de solução de Ringer lactato (30 mL. kg-1) antes da cirurgia. Mensurações hemodinâmicas, concentração de hemoglobina, parâmetros bioquímicos e testes de coagulação foram avaliados em três períodos durante o procedimento cirúrgico. Os pacientes receberam acompanhamento médico durante a internação e até 30 dias no período pós-operatório. O principal fator foi a necessidade de transfusão de hemácias entre os grupos durante a internação. Os fatores secundários foram parâmetros hemodinâmicos, tempo de internação, mortalidade e ocorrência de complicações clínicas. no período pós-operatório. O principal fator foi a necessidade de transfusão de hemácias entre os grupos durante a internação. Os fatores secundários foram parâmetros hemodinâmicos, tempo de internação, mortalidade e ocorrência de complicações clínicas. RESULTADOS: A transfusão de hemácias foi necessária em 17% dos pacientes do grupo HES e em 46% dos pacientes do grupo Ringer lactato (p = 0,029). Infecções pós-operatórias foram observadas com mais frequência no grupo de Ringer lactato (17%) em comparação com o grupo HES (0), p = 0,037. Não houve diferenças significativas entre os grupos em relação à mortalidade, ao tempo de internação e às complicações clínicas, exceto infecção. CONCLUSÕES: Durante a artroplastia de quadril, os pacientes tratados com hemodiluição hipervolêmica normal com hidroxietilamido 130/0,4 precisaram de menos transfusão e apresentaram índice menor de infecção em comparação com os pacientes que receberam Ringer lactato.

BACKGROUND AND OBJECTIVES: Hydroxyethyl starch (HES) 130/0.4 is considered an effective plasma expander when compared to crystalloids. There is controversy around its superiority regarding hemodynamic optimization and about possible detrimental effects on coagulation. The aim of this study was to compare the effects of HES 130/0.4 to lactated Ringer solution during hip arthroplasty in adult patients under spinal anesthesia regarding intraoperative bleeding, hemodynamic parameters, coagulation profile, transfusion requirements and clinical outcomes. METHODS: In this randomized, controlled trial, 48 patients scheduled for hip arthroplasty with spinal anesthesia were randomized into two groups: 24 patients were allocated to receive a preload of 15 mL.kg-1 of HES 130/0.4 and 24 patients received a preload of 30 mL.kg-1 lactated Ringer solution before surgery. Hemodynamic measurements, hemoglobin concentrations, biochemical parameters and coagulation tests were evaluated in three periods during surgical procedure. Patients received medical follow-up during their hospital stay and up to postoperative 30 days. Primary outcome was the requirement of red blood cell transfusion between groups during hospital stay. Secondary outcome were hemodynamic parameters, length of hospital stay, mortality and occurrence of clinical postoperative complications. RESULTS: Red blood cell transfusion was required in 17% of patients in the HES group and in 46% in the Ringer group (p = .029). Postoperative infections were more frequently observed in the Ringer group (17%) compared to the HES group (0), p = .037. There were no significant differences between groups in mortality, hospital length of stay and clinical complications other than infection. Conclusions: During hip arthroplasty, patients treated with hypervolemic hemodilution with hydroxyethyl starch 130/0.4 required less transfusion and presented lower infection rate compared to patients who received lactated Ringer.

JUSTIFICATIVA Y OBJETIVOS: El hidroxietilalmidón 130/0,4 (HES 130/0,4) está considerado como un expansivo plasmático efectivo cuando se le compara con los cristaloides. Existen controversias sobre su superioridad con relación a la optimización hemodinámica y sobre posibles efectos perjudiciales en la coagulación. El objetivo de este estudio, fue comparar los efectos del HES 130/0,4 con los de la solución de lactato de Ringer durante la artroplastia de cadera en pacientes adultos bajo raquianestesia, considerando el sangramiento intraoperatorio, los parámetros hemodinámicos, el coagulograma, la necesidad de transfusión y los resultados clínicos. MÉTODOS: En este estudio aleatorio y controlado, 48 pacientes citados para la artroplastia de cadera con raquianestesia fueron aleatoriamente divididos en dos grupos: 24 pacientes fueron ubicados para recibir una pre-carga de HES 130/0,4 (15 mL.kg-1) y 24 pacientes recibieron una pre-carga de solución de lactato de Ringer (30 mL.kg-1) antes de la cirugía. Las medidas hemodinámicas, concentración de hemoglobina, parámetros bioquímicos y los test de coagulación fueron evaluados en tres períodos durante el procedimiento quirúrgico. Los pacientes recibieron un acompañamiento médico durante el ingreso y de 30 días en el período del postoperatorio. El principal factor fue la necesidad de transfusión de hematíes entre los grupos durante el ingreso. Los factores secundarios fueron los parámetros hemodinámicos, tiempo de ingreso, mortalidad y aparecimiento de complicaciones clínicas. RESULTADOS: La transfusión de hematíes fue necesaria en un 17% de los pacientes del grupo HES y en un 46% de los pacientes del grupo lactato de Ringer (p = 0,029). Las infecciones postoperatorias fueron observadas con más frecuencia en el grupo lactato de Ringer (17%) en comparación con el grupo HES (0), p = 0,037. No hubo diferencias significativas entre los grupos con relación a la mortalidad, tiempo de ingreso y complicaciones clínicas, excepto en la infección. Conclusiones: Durante la artroplastia de cadera, los pacientes tratados con hemodilución hipervolémica normal con hidroxietilalmidón 130/0.4 necesitaron menos transfusión y presentaron un índice menor de infección en comparación con los pacientes que recibieron lactato de Ringer.

Lactate and base deficit are predictors of mortality in critically ill patients with cancer

OBJECTIVE: Cancer patients frequently require admission to intensive care unit. However, there are a few data regarding predictive factors for mortality in this group of patients. The aim of this study was to evaluate whether arterial lactate or standard base deficit on admission and after 24 hours can predict mortality for patients with cancer. METHODS: We evaluated 1,129 patients with severe sepsis, septic shock, or postoperative after high-risk surgery. Lactate and standard base deficit collected at admission and after 24 hours were compared between survivors and non-survivors. We evaluated whether these perfusion markers are independent predictors of mortality. RESULTS: There were 854 hospital survivors (76.5 percent). 24 h lactate .1.9 mmol/L and standard base deficit , -2.3 were independent predictors of intensive care unit mortality. 24 h lactate .1.9 mmol/L and 24 h standard base deficit , -2.3 mmol/Lwere independent predictors of hospital death. CONCLUSION: Our findings suggest that lactate and standard base deficit measurement should be included in the routine assessment of patients with cancer admitted to the intensive care unit with sepsis, septic shock or after highrisk surgery. These markers may be useful in the adequate allocation of resources in this population.