Goal-directed therapy guided by the FloTrac sensor in major surgery: a systematic review and meta-analysis.

OBJECTIVE: To provide insights into the potential benefits of goal-directed therapy guided by FloTrac in reducing postoperative complications and improving outcomes. METHODS: We performed a systematic review and meta-analysis of randomized controlled trials to evaluate goal-directed therapy guided by FloTrac in major surgery, comparing goal-directed therapy with usual care or invasive monitoring in cardiac and noncardiac surgery subgroups. The quality of the articles and evidence were evaluated with a risk of bias tool and GRADE. RESULTS: We included 29 randomized controlled trials with 3,468 patients. Goal-directed therapy significantly reduced the duration of hospital stay (mean difference -1.43 days; 95%CI 2.07 to -0.79; I2 81%), intensive care unit stay (mean difference -0.77 days; 95%CI -1.18 to -0.36; I2 93%), and mechanical ventilation (mean difference -2.48 hours, 95%CI -4.10 to -0.86, I2 63%). There was no statistically significant difference in mortality, myocardial infarction, acute kidney injury or hypotension, but goal-directed therapy significantly reduced the risk of heart failure or pulmonary edema (RR 0.46; 95%CI 0.23 - 0.92; I2 0%). CONCLUSION: Goal-directed therapy guided by the FloTrac sensor improved clinical outcomes and shortened the length of stay in the hospital and intensive care unit in patients undergoing major surgery. Further research can validate these results using specific protocols and better understand the potential benefits of FloTrac beyond these outcomes.

Estado actual y retos futuros en el tratamiento de las enfermedades reumáticas / Current status and future challenges in the treatment of rheumatic diseases

Las nuevas estrategias, que incluyen el diagnóstico y el tratamiento tempranos, el enfoque de tratamiento dirigido a un objetivo, la remisión como ese objetivo principal del tratamiento, la participación de los pacientes en las decisiones terapéuticas, junto con el desarrollo de nuevos tratamientos efectivos, han cambiado las expectativas de los reumatólogos y de los pacientes con enfermedades reumáticas. Todavía existen, sin embargo, importantes desafíos tales como la seguridad a largo plazo de los tratamientos actuales y poder escoger tratamientos más individualizados y eficaces, de forma tal de elegir el mejor tratamiento para cada paciente. El futuro, como en el resto de la medicina, probablemente sea la prevención del desarrollo de enfermedades reumáticas. Discutiremos estos temas en esta revisión. (AU)

New strategies, including early diagnosis and treatment, targeted therapy, remission as the main objective of treatment, patient involvement in therapeutic decision-making, and the development of new effective therapies, have changed the expectations of rheumatologists and patients with rheumatic diseases.There are still serious challenges, such as the long-term safety of current treatments and the ability to make more individualized and effective treatments to choose the best treatment for each patient. The future, as that of the whole of medical science, will probably lie in preventing the development of rheumatic diseases. We will discuss these issues in this review. (AU)

The role of goal-directed therapy in the prevention of acute kidney injury after major gastrointestinal surgery: Substudy of the OPTIMISE trial.

BACKGROUND: Acute kidney injury (AKI) is an important adverse outcome after major surgery. Peri-operative goal-directed haemodynamic therapy (GDT) may improve outcomes by reducing complications such as AKI. OBJECTIVE: To determine if GDT was associated with a reduced incidence of postoperative AKI according to specific renal biomarkers. DESIGN: Prospective substudy of the OPTIMISE trial, a multicentre randomised controlled trial comparing peri-operative GDT to usual patient care. SETTING: Four UK National Health Service hospitals. PATIENTS: A total of 287 high-risk patients aged at least 50 years undergoing major gastrointestinal surgery. OUTCOME MEASURES: The primary outcome measure was AKI defined as urinary neutrophil gelatinase-associated lipase (NGAL) at least 150 ng ml 24 and 72 h after surgery. Secondary outcomes were between-group differences in NGAL measurements and NGAL : creatinine ratios 24 and 72 h after surgery and AKI stage 2 or greater according to Kidney Disease Improving Global Outcomes (KDIGO) criteria within 30 days of surgery. RESULTS: In total, 20 of 287 patients (7%) experienced postoperative AKI of KDIGO grade 2 or 3 within 30 days. The proportion of patients with urinary NGAL at least 150 ng ml 24 or 72 h after surgery was similar in the two groups [GDT 31/144 (21.5%) patients vs. usual patient care 28/143 (19.6%) patients; P = 0.88]. Absolute values of urinary NGAL were also similar at 24 h (GDT 53.5 vs. usual patient care 44.1 ng ml; P = 0.38) and 72 h (GDT 45.1 vs. usual patient care 41.1 ng ml; P = 0.50) as were urinary NGAL : creatinine ratios at 24 h (GDT 45 vs. usual patient care 43 ng mg; P = 0.63) and 72 h (GDT 66 vs. usual patient care 63 ng mg; P = 0.62). The incidence of KDIGO-defined AKI was also similar between the groups [GDT 9/144 (6%) patients vs. usual patient care 11/143 (8%) patients; P = 0.80]. CONCLUSION: In this trial, GDT did not reduce the incidence of AKI amongst high-risk patients undergoing major gastrointestinal surgery. This may reflect improving standards in usual patient care. TRIAL REGISTRATION: OPTIMISE Trial Registration ISRCTN04386758.

Goal-directed hemodynamic management in patients undergoing primary debulking gynaecological surgery: A matched-controlled precision medicine study.

BACKGROUND: Usefulness of intraoperative goal-directed hemodynamic management (GDHM) for patients without comorbidities is debated. After clinical implementation of a pulse contour analysis-guided GDHM protocol, which foresees early vasopressor use for recruiting unstressed volume, we conducted a matched-controlled analysis to explore its impact on the amount of fluids intraoperatively administered to patients without comorbidities who underwent extended abdominal surgery for ovarian cancer. METHODS: After 1:1 matching accounting for body mass index, oncologic disease severity and intraoperative blood losses, 22 patients treated according to this GDHM protocol were compared to a control group of 22 patients who had been managed according to the clinical decision of attending physicians, taken without advanced monitoring. Results are displayed as median[interquartile range]. RESULTS: All analyzed patients underwent radical hysterectomy, bilateral adnexectomy, bowel resection, peritonectomy and extended pelvic/periaortic lymphadenectomy; median length of surgery was 517[480-605] min in patients receiving GDHM and 507[480-600] min in control group. Intraoperatively, patients undergoing GDHM received less fluids (crystalloids 2950[2700-3300] vs. 5150[4700-6000] mL, p < 0.001; colloids 100[50-200] vs. 750[500-1000] mL, p < 0.001) and showed a trend to more frequent vasopressor administration (32 vs 9%, p = 0.13). Greater intraoperative diuresis (540[480-620] mL vs. 450[400-500] mL, p = 0.007), lower blood lactates at surgery end (1.5[1.1-2] vs. 4.1[3.3-5] mmol/L, p < 0.001), shorter time to bowel function recovery (1 [1, 2] vs. 4 [3-5] days, p < 0.001) and hospital discharge (7 [6-8] vs 12 [9-16] days, p < 0.0001) were detected in patients receiving GDHM. CONCLUSIONS: In high-tumor load gynaecological patients without comorbidities who receive radical and prolonged surgery, intraoperative use of this novel GDHM protocol helped limit fluids administration with safety.

Plano de análise estatística para o estudo do tratamento precoce baseado em metas com utilização de uma visão fisiológica holística - estudo ANDROMEDA-SHOCK: um estudo randomizado e controlado / Statistical analysis plan for early goal-directed therapy using a physiological holistic view - the ANDROMEDA-SHOCK: a randomized controlled trial

RESUMO Fundamentação: O estudo ANDROMEDA-SHOCK é um estudo internacional, multicêntrico, randomizado e controlado comparando ressuscitação guiada pela perfusão periférica com ressuscitação guiada pelo lactato em pacientes com choque séptico, com a finalidade de testar a hipótese de que a ressuscitação guiada pela perfusão periférica associa-se a menor morbidade e mortalidade. Objetivo: Relatar o plano de análise estatística para o estudo ANDROMEDA-SHOCK. Métodos: Descrevemos o delineamento do estudo, os objetivos primário e secundários, pacientes, métodos de randomização, intervenções, desfechos e tamanho da amostra. Descrevemos nossos planos de análise estatística para os desfechos primários, secundários e terciários. Também descrevemos as análises de subgrupos e sensibilidade. Finalmente, fornecemos detalhes para a apresentação dos resultados, inclusive modelos de tabelas para apresentar as características basais, a evolução das variáveis de hemodinâmica e perfusão, e os efeitos dos tratamentos nos desfechos. Conclusão: Segundo as melhores práticas de pesquisa, relatamos nosso plano de análise estatística e plano de gestão de dados antes do fechamento da base de dados e do início da análise dos dados. Nossa expectativa é que este procedimento previna a ocorrência de vieses na análise e incremente a utilidade dos resultados relatados.

ABSTRACT Background: ANDROMEDA-SHOCK is an international, multicenter, randomized controlled trial comparing peripheral perfusion-targeted resuscitation to lactate-targeted resuscitation in patients with septic shock in order to test the hypothesis that resuscitation targeting peripheral perfusion will be associated with lower morbidity and mortality. Objective: To report the statistical analysis plan for the ANDROMEDA-SHOCK trial. Methods: We describe the trial design, primary and secondary objectives, patients, methods of randomization, interventions, outcomes, and sample size. We describe our planned statistical analysis for the primary, secondary and tertiary outcomes. We also describe the subgroup and sensitivity analyses. Finally, we provide details for presenting our results, including mock tables showing baseline characteristics, the evolution of hemodynamic and perfusion variables, and the effects of treatments on outcomes. Conclusion: According to the best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and initiating the analyses. We anticipate that this procedure will prevent analysis bias and enhance the utility of the reported results.

Effect of goal-directed fluid therapy on early cognitive function in elderly patients with spinal stenosis: A Case-Control Study.

PURPOSE: To explore effect of goal-directed fluid therapy (GDFT) on early cognitive function in elderly patients with spinal stenosis. METHODS: 83 elderly patients with spinal stenosis were randomly classified into two groups: control group (n = 40) and GDFT group (n = 43). The Montreal Cognitive Assessment (MoCA) score, IL-6 and S100ß levels, hemodynamic parameters, cerebral oxygen saturation (rSO2), arterial lactic acid values, output of surgery, operation time and cases of hypotension, intraoperative complications within 7 days were recorded for all patients. RESULTS: The incidence of postoperative cognitive dysfunction (POCD) was about 21.67% in this study. The MoCA scores, inflammatory mediators, perfusion indexes (rSO2 and lactic acid)and intraoperative hemodynamics(HR, MAP, and CI)were not all the same at different time points (P < 0.05). The levels of inflammatory mediators (IL-6 and S100ß) in GDFT group were lower than those in the control group (P < 0.05). Total intake, amount of lactated Ringer's solution and cases of hypotension in GDFT group were significantly lower than control group (P < 0.05), but amount of voluven was higher than control group(P < 0.05). Compared with control group, the incidence of postoperative delirium, nausea and vomiting, and hypotension in GDFT group was lower (P < 0.05). CONCLUSIONS: GDFT can maintain the stability of perioperative hemodynamics in the prone position of elderly patients with spinal stenosis, improve the balance between perfusion of tissue and organ and supply and demand of oxygen, reduce the inflammatory response, and reduce the incidence of early POCD in this type of surgery.