Vasopressin in vasoplegic shock in surgical patients: systematic review and meta-analysis.

PURPOSE: Vasoplegia, or vasoplegic shock, is a syndrome whose main characteristic is reducing blood pressure in the presence of a standard or high cardiac output. For the treatment, vasopressors are recommended, and the most used is norepinephrine. However, new drugs have been evaluated, and conflicting results exist in the literature. METHODS: This is a systematic review of the literature with meta-analysis, written according to the recommendations of the PRISMA report. The SCOPUS, PubMed, and ScienceDirect databases were used to select the scientific articles included in the study. Searches were conducted in December 2022 using the terms "vasopressin," "norepinephrine," "vasoplegic shock," "postoperative," and "surgery." Meta-analysis was performed using Review Manager (RevMan) 5.4. The endpoint associated with the study was efficiency in treating vasoplegic shock and reduced risk of death. RESULTS: In total, 2,090 articles were retrieved; after applying the inclusion and exclusion criteria, ten studies were selected to compose the present review. We found no significant difference when assessing the outcome mortality comparing vasopressin versus norepinephrine (odds ratio = 1.60; confidence interval 0.47-5.50), nor when comparing studies on vasopressin versus placebo. When we analyzed the length of hospital stay compared to the use of vasopressin and norepinephrine, we identified a shorter length of hospital stay in cases that used vasopressin; however, the meta-analysis did not demonstrate statistical significance. CONCLUSIONS: Considering the outcomes included in our study, it is worth noting that most studies showed that using vasopressin was safe and can be considered in managing postoperative vasoplegic shock.

Vasopressin in vasoplegic shock in surgical patients: systematic review and meta-analysis

Purpose: Vasoplegia, or vasoplegic shock, is a syndrome whose main characteristic is reducing blood pressure in the presence of a standard or high cardiac output. For the treatment, vasopressors are recommended, and the most used is norepinephrine. However, new drugs have been evaluated, and conflicting results exist in the literature. Methods: This is a systematic review of the literature with meta-analysis, written according to the recommendations of the PRISMA report. The SCOPUS, PubMed, and ScienceDirect databases were used to select the scientific articles included in the study. Searches were conducted in December 2022 using the terms "vasopressin," "norepinephrine," "vasoplegic shock," "postoperative," and "surgery." Meta-analysis was performed using Review Manager (RevMan) 5.4. The endpoint associated with the study was efficiency in treating vasoplegic shock and reduced risk of death. Results: In total, 2,090 articles were retrieved; after applying the inclusion and exclusion criteria, ten studies were selected to compose the present review. We found no significant difference when assessing the outcome mortality comparing vasopressin versus norepinephrine (odds ratio = 1.60; confidence interval 0.47-5.50), nor when comparing studies on vasopressin versus placebo. When we analyzed the length of hospital stay compared to the use of vasopressin and norepinephrine, we identified a shorter length of hospital stay in cases that used vasopressin; however, the meta-analysis did not demonstrate statistical significance. Conclusions: Considering the outcomes included in our study, it is worth noting that most studies showed that using vasopressin was safe and can be considered in managing postoperative vasoplegic shock.

Impact of Preoperative Functional Capacity on Postoperative Outcomes in Congenital Heart Surgery: An Observational and Prospective Study. / Impacto da Capacidade Funcional Pré-operatória nos Resultados Pós-Operatórios de Cirurgia de Cardiopatia Congênita: Estudo Observacional e Prospectivo.

BACKGROUND: Despite advances in surgical technique and postoperative care in congenital heart disease, cardiovascular morbidity is still high. OBJECTIVE: To evaluate the association between preoperative cardiovascular fitness of children and adolescents, measured by the 6-minute walk test (6MWT) and Heart Rate Variability (HRV), and the occurrence of cardiogenic, septic shock and death in the postoperative period. METHODS: Prospective, observational clinic study including 81 patients aged from 8 to 18 years. In the preoperative period, the 6MWT (distance walked and SpO2) and HRV were performed. The adjusted risk score for surgeries for congenital heart disease (RACHS-1) was applied to predict the surgical risk factor for mortality. The occurrence of at least one of the listed complications was considered as a combined event. P values < 0.05 were considered as significant. RESULTS: Of the patients, 59% were male, with mean age of 12 years; 33% were cyanotic; and 72% had undergone previous cardiac surgery. Cardiogenic shock was the most common complication, and 31% had a combined event. Prior to surgery, type of current heart disease, RACHS-1, SpO2at rest, during the 6MWT and recovery were selected for the multivariate analysis. The SpO2at recovery by the 6MWT remained as an independent risk factor (OR 0.93, 95%CI [0.88 - 0.99], p=0.02) for the increasing occurrence of combined events. CONCLUSION: SpO2after the application of the 6MWT in the preoperative period was an independent predictor of prognosis in children and adolescents undergoing surgical correction; the walked distance and the HRV did not present this association.

FUNDAMENTO: Apesar de avanços em técnicas cirúrgicas e cuidados pós-operatórios em cardiopatia congênita, a morbidade cardiovascular permanece elevada. OBJETIVO: Avaliar a associação do condicionamento pré-operatório de crianças e adolescentes com cardiopatias, mensurado por teste de caminhada de 6-minutos (TC6M) e variabilidade da frequência cardíaca (VFC), com a ocorrência de choque cardiogênico, séptico e morte no período pós-operatório. MÉTODOS: Estudo clínico prospectivo e observacional de 81 pacientes de 8 a 18 anos. No período pré-operatório foram realizados o TC6M (distância caminhada e SpO2) e a VFC. O escore de risco ajustado para cirurgia de cardiopatia congênita ( RACHS-1 ) foi aplicado para predizer o fator de risco cirúrgico para mortalidade. A ocorrência de pelo menos uma das complicações citadas foi considerada como evento combinado. Valores de p<0,05 foram considerados significantes. RESULTADOS: Dos 81 pacientes, 59% eram do sexo masculino, com idade média de 12 anos; 33% eram cianóticos; e 72% já tinham realizado cirurgias prévias. O choque cardiogênico foi a complicação mais comum, e 31% apresentaram evento combinado. Cirurgia prévia, tipo de cardiopatia atual, RACHS-1 , SpO2 em repouso, durante e após recuperação do TC6M foram selecionados para o estudo multivariado. A SpO2 após o TC6M permaneceu como fator de risco independente para aumentar a ocorrência de evento combinado no pós-operatório (OR: 0,93, IC95% [0,88 ­ 0,99], p=0,02). CONCLUSÃO: O SpO2 após o TC6M no período pré-operatório foi o fator independente preditor de prognóstico no pós-operatório em crianças e adolescentes submetidos à correção cirúrgica; a distância caminhada e as variáveis da VFC não tiveram a mesma associação.

Impacto da Capacidade Funcional Pré-operatória nos Resultados Pós-Operatórios de Cirurgia de Cardiopatia Congênita: Estudo Observacional e Prospectivo / Impact of Preoperative Functional Capacity on Postoperative Outcomes in Congenital Heart Surgery: An Observational and Prospective Study

Resumo Fundamento Apesar de avanços em técnicas cirúrgicas e cuidados pós-operatórios em cardiopatia congênita, a morbidade cardiovascular permanece elevada. Objetivo Avaliar a associação do condicionamento pré-operatório de crianças e adolescentes com cardiopatias, mensurado por teste de caminhada de 6-minutos (TC6M) e variabilidade da frequência cardíaca (VFC), com a ocorrência de choque cardiogênico, séptico e morte no período pós-operatório. Métodos Estudo clínico prospectivo e observacional de 81 pacientes de 8 a 18 anos. No período pré-operatório foram realizados o TC6M (distância caminhada e SpO2) e a VFC. O escore de risco ajustado para cirurgia de cardiopatia congênita ( RACHS-1 ) foi aplicado para predizer o fator de risco cirúrgico para mortalidade. A ocorrência de pelo menos uma das complicações citadas foi considerada como evento combinado. Valores de p<0,05 foram considerados significantes. Resultados Dos 81 pacientes, 59% eram do sexo masculino, com idade média de 12 anos; 33% eram cianóticos; e 72% já tinham realizado cirurgias prévias. O choque cardiogênico foi a complicação mais comum, e 31% apresentaram evento combinado. Cirurgia prévia, tipo de cardiopatia atual, RACHS-1 , SpO2 em repouso, durante e após recuperação do TC6M foram selecionados para o estudo multivariado. A SpO2 após o TC6M permaneceu como fator de risco independente para aumentar a ocorrência de evento combinado no pós-operatório (OR: 0,93, IC95% [0,88 - 0,99], p=0,02). Conclusão O SpO2 após o TC6M no período pré-operatório foi o fator independente preditor de prognóstico no pós-operatório em crianças e adolescentes submetidos à correção cirúrgica; a distância caminhada e as variáveis da VFC não tiveram a mesma associação.

Abstract Background Despite advances in surgical technique and postoperative care in congenital heart disease, cardiovascular morbidity is still high. Objective To evaluate the association between preoperative cardiovascular fitness of children and adolescents, measured by the 6-minute walk test (6MWT) and Heart Rate Variability (HRV), and the occurrence of cardiogenic, septic shock and death in the postoperative period. Methods Prospective, observational clinic study including 81 patients aged from 8 to 18 years. In the preoperative period, the 6MWT (distance walked and SpO2) and HRV were performed. The adjusted risk score for surgeries for congenital heart disease (RACHS-1) was applied to predict the surgical risk factor for mortality. The occurrence of at least one of the listed complications was considered as a combined event. P values < 0.05 were considered as significant. Results Of the patients, 59% were male, with mean age of 12 years; 33% were cyanotic; and 72% had undergone previous cardiac surgery. Cardiogenic shock was the most common complication, and 31% had a combined event. Prior to surgery, type of current heart disease, RACHS-1, SpO2at rest, during the 6MWT and recovery were selected for the multivariate analysis. The SpO2at recovery by the 6MWT remained as an independent risk factor (OR 0.93, 95%CI [0.88 - 0.99], p=0.02) for the increasing occurrence of combined events. Conclusion SpO2after the application of the 6MWT in the preoperative period was an independent predictor of prognosis in children and adolescents undergoing surgical correction; the walked distance and the HRV did not present this association.

Incidence and risk factors of postoperative visual function impairment in elderly patients undergoing nonocular surgery: a prospective cohort study.

BACKGROUND: Elderly patients may present with visual function impairment after surgery, which may increase the incidence of postoperative delirium and falls and decrease their quality of life. The aim of this study was to assess visual function in elderly patients after long-duration nonocular surgery to determine the incidence and risk factors for visual function impairment after surgery. METHODS: This prospective and observational study included patients aged between 60 and 80 years who had been scheduled for elective nonocular surgery expected to last longer than 120 minutes under general anesthesia. Ocular examinations were performed before surgery, on postoperative day 3 and on postoperative day 21 and consisted of a LogMAR-Snellen chart test, a Jager chart test, biomicroscopy, optical tonometry, ocular motility assessment and fundoscopy. Baseline characteristics of all patients as well as intraoperative and postoperative data were collected. RESULTS: A total of 107 patients were included in the final analysis. Visual function impairment was diagnosed in 21 patients (19.6%) at POD 3. Of those, 7 patients (6.5%) still presented with visual changes at POD 21. On POD 3, compared with that at baseline, visual acuity assessed by the Snellen chart test had decreased in these patients. Significant differences regarding refraction tests and intraocular pressure measures were also found. Multivariable analysis identified diabetes mellitus, duration of surgery, hypotension during anesthesia induction, lower peripheral oxygen saturation at the end of the procedure and body mass index as independent risk factors for postoperative visual impairment. CONCLUSION: In elderly patients undergoing long-duration nonocular procedures under general anesthesia, the incidence of visual function impairment was considerably high. Most patients recovered to baseline visual function, but clinically significant visual changes may still be present 3 weeks after surgery. Obesity, diabetes mellitus, and the duration of surgical and anesthetic techniques appear to increase the risk of visual impairment after surgery.

Intensive care management of patients with COVID-19: a practical approach.

SARS-CoV-2, the causative agent of coronavirus disease 2019 (COVID-19), is responsible for the largest pandemic facing humanity since the Spanish flu pandemic in the early twentieth century. Since there is no specific antiviral treatment, optimized support is the most relevant factor in the patient's prognosis. In the hospital setting, the identification of high-risk patients for clinical deterioration is essential to ensure access to intensive treatment of severe conditions in a timely manner. The initial management of hypoxemia includes conventional oxygen therapy, high-flow nasal canula oxygen, and non-invasive ventilation. For patients requiring invasive mechanical ventilation, lung-protective ventilation with low tidal volumes and plateau pressure is recommended. Cardiovascular complications are frequent and include myocardial injury, thrombotic events, myocarditis, and cardiogenic shock. Acute renal failure is a common complication and is a marker of poor prognosis, with significant impact in costs and resources allocation. Regarding promising therapies for COVID-19, the most promising drugs until now are remdesivir and corticosteroids although further studies may be needed to confirm their effectiveness. Other therapies such as, tocilizumab, anakinra, other anti-cytokine drugs, and heparin are being tested in clinical trials. Thousands of physicians are living a scenario that none of us have ever seen: demand for hospital exceed capacity in most countries. Until now, the certainty we have is that we should try to decrease the number of infected patients and that an optimized critical care support is the best strategy to improve patient's survival.

Failure of Noninvasive Ventilation in Acute Respiratory Failure is Associated with Higher Mortality in Patients with Solid Tumors: A Retrospective Cohort Study.

BACKGROUND: Noninvasive Ventilation (NIV) is a well-established treatment for Acute Respiratory Failure (ARF) in hematological cancer. However, the NIV impact on mortality in patients with solid tumors is unclear. OBJECTIVE: To define the factors associated with NIV failure and mortality and to describe the mortality risk of patients with solid tumors requiring NIV for ARF treatment in the intensive care unit (ICU). METHODS: A retrospective cohort study of patients with solid tumors admitted into an ICU between Jan 2016 and Dec 2017, for cancer treatment, with ARF diagnosis that had used the NIV as first-line treatment. Our primary outcome was ICU and in-hospital mortality. The secondary outcome was NIV failure. A Cox proportional hazards regression was used to identify variables associated with mortality and NIV failure. Kaplan-Meier analyses were performed to demonstrate cumulative survival. RESULTS: A total of 226 patients with solid tumors were included. The ICU and hospital mortality rates were 57.5% and 69.5%, respectively. NIV failed in 52.2% of the patients. The use of vasopressors (HR 2.48 [95% CI: 1.43-4.30] p = 0.001), baseline lactate (HR 1.20 [95% CI: 1.07-1.35] p = 0.003), baseline PaO2/FiO2 ratio (HR1.33 [1.11-1.55] p = 0.002), and NIV success (HR0.17 [95% CI: 0.10-0.27] p = 0.005) was independently associated with hospital mortality. The use of vasopressors (HR 2.58 [95% CI: 1.41-4.73] p = 0.02), NIV duration (HR 0.93 [95% CI: 0.89-0.97] p = 0.003), and baseline lactate (HR 1.13 [95% CI: 1.06-1.20] p = 0.001) was associated with NIV failure. CONCLUSIONS: NIV failure was independently associated with an increase in both ICU and hospital mortality rates. In patients with NIV therapy indication, the duration of this intervention was associated with NIV failure.

Dobutamine-sparing versus dobutamine-to-all strategy in cardiac surgery: a randomized noninferiority trial.

BACKGROUND: The 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). RESULTS: A 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. DISCUSSION: Although 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.

The Heart and COVID-19: What Cardiologists Need to Know. / O Coração e a COVID-19: O que o Cardiologista Precisa Saber.

In face of the pandemic of the novel coronavirus disease 2019 (COVID-19), the management of patients with cardiovascular risk factors and/or disease is challenging. The cardiovascular complications evidenced in patients with COVID-19 derive from several mechanisms, ranging from direct viral injury to complications secondary to the inflammatory and thrombotic responses to the infection. The proper care of patients with COVID-19 requires special attention to the cardiovascular system aimed at better outcomes.

Frente à pandemia da doença causada pelo novo coronavírus (COVID-19), o manejo do paciente com fator de risco e/ou doença cardiovascular é desafiador nos dias de hoje. As complicações cardiovasculares evidenciadas nos pacientes com COVID-19 resultam de vários mecanismos, que vão desde lesão direta pelo vírus até complicações secundárias à resposta inflamatória e trombótica desencadeada pela infecção. O cuidado adequado do paciente com COVID-19 exige atenção ao sistema cardiovascular em busca de melhores desfechos.

O Coração e a COVID-19: O que o Cardiologista Precisa Saber / The Heart and COVID-19: What Cardiologists Need to Know

Resumo Frente à pandemia da doença causada pelo novo coronavírus (COVID-19), o manejo do paciente com fator de risco e/ou doença cardiovascular é desafiador nos dias de hoje. As complicações cardiovasculares evidenciadas nos pacientes com COVID-19 resultam de vários mecanismos, que vão desde lesão direta pelo vírus até complicações secundárias à resposta inflamatória e trombótica desencadeada pela infecção. O cuidado adequado do paciente com COVID-19 exige atenção ao sistema cardiovascular em busca de melhores desfechos.

Abstract In face of the pandemic of the novel coronavirus disease 2019 (COVID-19), the management of patients with cardiovascular risk factors and/or disease is challenging. The cardiovascular complications evidenced in patients with COVID-19 derive from several mechanisms, ranging from direct viral injury to complications secondary to the inflammatory and thrombotic responses to the infection. The proper care of patients with COVID-19 requires special attention to the cardiovascular system aimed at better outcomes.

The Heart and COVID-19: What Cardiologists Need to Know

In face of the pandemic of the novel coronavirus disease 2019 (COVID-19), the management of patients with cardiovascular risk factors and/or disease is challenging. The cardiovascular complications evidenced in patients with COVID-19 derive from several mechanisms, ranging from direct viral injury to complications secondary to the inflammatory and thrombotic responses to the infection. The proper care of patients with COVID-19 requires special attention to the cardiovascular system aimed at better outcomes.

O Coração e a COVID-19: O que o Cardiologista Precisa Saber

Frente à pandemia da doença causada pelo novo coronavírus (COVID-19), o manejo do paciente com fator de risco e/ou doença cardiovascular é desafiador nos dias de hoje. As complicações cardiovasculares evidenciadas nos pacientes com COVID-19 resultam de vários mecanismos, que vão desde lesão direta pelo vírus até complicações secundárias à resposta inflamatória e trombótica desencadeada pela infecção. O cuidado adequado do paciente com COVID-19 exige atenção ao sistema cardiovascular em busca de melhores desfechos.

Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients: The VANCS II Randomized Clinical Trial.

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.

The effect of a rapid molecular blood test on the use of antibiotics for nosocomial sepsis: a randomized clinical trial.

BACKGROUND: Appropriate use of antimicrobials is essential to improve outcomes in sepsis. The aim of this study was to determine whether the use of a rapid molecular blood test-SeptiFast (SF) reduces the antibiotic consumption through early de-escalation in patients with nosocomial sepsis compared with conventional blood cultures (BCs). METHODS: This was a prospective, randomized, superiority, controlled trial conducted at Sao Paulo Heart Institute in the period October 2012-May 2016. Adult patients admitted to the hospital for at least 48 h with a diagnosis of nosocomial sepsis underwent microorganism identification by both SF test and BCs. Patients randomized into the intervention group received antibiotic therapy adjustment according to the results of SF. Patients randomized into the control group received standard antibiotic adjustment according to the results of BCs. The primary endpoint was antimicrobial consumption during the first 14 days after randomization. RESULTS: A total of 200 patients were included (100 in each group). The intention to treat analysis found no significant differences in median antibiotic consumption. In the subgroup of patients with positive SF and blood cultures (19 and 25 respectively), we found a statistically significant reduction in the median antimicrobial consumption which was 1429 (1071-2000) days of therapy (DOT)/1000 patients-day in the intervention group and 1889 (1357-2563) DOT/1000 patients-day in the control group (p = 0.017), in the median time of antimicrobial de-escalation (8 versus 54 h-p < 0.001), in the duration of antimicrobial therapy (p = 0.039) and in anti-gram-positive antimicrobial costs (p = 0.002). Microorganism identification was possible in 24.5% of patients (45/184) by SF and 21.2% (39/184) by BC (p = 0.45). CONCLUSION: This randomized clinical trial showed that the use of a rapid molecular-based pathogen identification test does not reduce the median antibiotic consumption in nosocomial sepsis. However, in patients with positive microbiological tests, the use of SeptiFast reduced antimicrobial consumption through early de-escalation compared to conventional blood cultures. These results were driven by a reduction in the consumption of antimicrobials used for Gram-positive bacteria. TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov (NCT01450358) on 12th October 2011.

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.

Perioperative statin therapy in cardiac and non-cardiac surgery: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: The effects of perioperative statin therapy on clinical outcome after cardiac or non-cardiac surgery are controversial. We aimed to assess the association between perioperative statin therapy and postoperative outcome. METHODS: Electronic databases were searched up to May 1, 2018, for randomized controlled trials of perioperative statin therapy versus placebo or no treatment in adult cardiac or non-cardiac surgery. Postoperative outcomes were: myocardial infarction, stroke, acute kidney injury (AKI), and mortality. We calculated risk ratio (RR) or odds ratio (OR) and 95% confidence interval (CI) using fixed-effects meta-analyses. We performed meta-regression and subgroup analyses to assess the possible influence of statin therapy regimen on clinical outcomes and trial sequential analysis to evaluate the risk of random errors and futility. RESULTS: We included data from 35 RCTs involving 8200 patients. Perioperative statin therapy was associated with lower incidence of postoperative myocardial infarction in non-cardiac surgery (OR = 0.44 [95% CI 0.30-0.64], p < 0.0001), but not in cardiac surgery (OR = 0.93 [95% CI 0.70-1.24], p = 0.61) (psubgroup = 0.002). Higher incidence of AKI was present in cardiac surgery patients receiving perioperative statins (RR = 1.15 [95% CI 1.00-1.31], p = 0.05), nonetheless not in non-cardiac surgery (RR = 1.52 [95% CI 0.71-3.26], p = 0.28) (psubgroup = 0.47). No difference in postoperative stroke and mortality was present in either cardiac or non-cardiac surgery. However, low risk of bias trials performed in cardiac surgery showed a higher mortality with statins versus placebo (OR = 3.71 [95% CI 1.03-13.34], p = 0.04). Subgroup and meta-regression analyses failed to find possible relationships between length of statin regimens and clinical outcomes. Trial sequential analysis suggested no firm conclusions on the topic. CONCLUSIONS: Perioperative statins appear to be protective against postoperative myocardial infarction in non-cardiac surgery and associated with higher AKI in cardiac surgery. Possible positive or even negative effects on mortality could not be excluded and merits further investigations. Currently, no randomized evidence supports the systematic administration of statins in surgical patients.

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.

Effect of a Perioperative Intra-Aortic Balloon Pump in High-Risk Cardiac Surgery Patients: A Randomized Clinical Trial.

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 São 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 (51 hr [interquartile range, 32-94 hr] vs 39 hr [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.

Nitric Oxide in Cardiac Surgery: A Meta-Analysis of Randomized Controlled Trials.

OBJECTIVES: 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.

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.