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

ABSTRACT: 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?

SUBMITTER: Gerent ARM

PROVIDER: S-EPMC5964647 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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

Gerent Aline Rejane Muller ARM Almeida Juliano Pinheiro JP Fominskiy Evgeny E Landoni Giovanni G de Oliveira Gisele Queiroz GQ Rizk Stephanie Itala SI Fukushima Julia Tizue JT Simoes Claudia Marques CM Ribeiro Ulysses U Park Clarice Lee CL Nakamura Rosana Ely RE Franco Rafael Alves RA Cândido Patricia Inês PI Tavares Cintia Rosa CR Camara Ligia L Dos Santos Rocha Ferreira Graziela G de Almeida Elisangela Pinto Marinho EPM Filho Roberto Kalil RK Galas Filomena Regina Barbosa Gomes FRBG Hajjar Ludhmila Abrahão LA

Critical care (London, England) 20180523 1

<h4>Background</h4>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.<h4>Methods</h4>A randomized, parallel-group, superiority trial was performed in a tertiary onc ...[more]

PMID: 29792232

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Project description:BackgroundPerioperative goal-directed fluid therapy (GDFT) aiming to maintain individual fluid balance based on sensitive parameters was prevalent in major surgery, especially in enhanced recovery after surgery (ERAS) pathway. This meta-analysis was conducted for the purpose of evaluating whether GDFT impacts on occurrence of postoperative ileus and whether its application is worthwhile in gastrointestinal surgery.MethodsA systematic search of RCTs compared GDFT with other fluid management in patients undergoing gastrointestinal surgery from the PubMed, Web of Science, Embase, Cochrane Library databases was implemented. The primary outcome is incidence of postoperative ileus. Other outcome measures were length of hospital stay (LOS), postoperative morbidity and mortality. Subgroup analysis was planed a prior to verify the definite role of GDFT.Results12 trials consisted of 1836 patients were included in the final analysis. GDFT did not influence the occurrence of postoperative ileus (relative risk, RR 0.71, 95% confidence interval, CI 0.47-1.07, P?=?.10), with moderate heterogeneity (I?=?29%, P?=?.16). No difference was found between GDFT and control groups in LOS (mean difference -0.17 days, 95% CI -0.73 to 0.39, P?=?.55), total complication rate (RR 0.92, 95% CI 0.81-1.05, P?=?.23), and 30-day mortality (RR 0.91, 95% CI 0.47-1.75, P?=?.77). In other secondary outcomes, only wound infection rate was lower in the GDFT group (RR 0.68, 95% CI 0.50-0.93, P?=?.02). When performed subgroup analysis, GDFT was superior in reduction ileus only when compared with standard therapy or in those outside ERAS.ConclusionsIt is possible that GDFT dose not affect the occurrence of postoperative ileus in gastrointestinal surgery. It scarcely influences postoperative morbidity and mortality as well. However, lower incidence of ileus is observed in GDFT group either outside ERAS or compared with standard fluid therapy. Probably, GDFT may not be necessary in the ERAS pathway or if a hybrid approach is adopted.

Project description:BackgroundThe effect of a combination of a goal-directed fluid protocol and preoperative carbohydrate loading on postoperative complications in elderly patients still remains unknown. Therefore, we designed this trial to evaluate the relative impact of preoperative carbohydrate loading and intraoperative goal-directed fluid therapy versus conventional fluid therapy (CFT) on clinical outcomes in elderly patients following gastrointestinal surgery.MethodsThis prospective randomized controlled trial with 120 patients over 65 years undergoing gastrointestinal surgery were randomized into a CFT group (n = 60) with traditional methods of fasting and water-deprivation, and a GDFT group (n = 60) with carbohydrate (200 ml) loading 2 h before surgery. The CFT group underwent routine monitoring during surgery, however, the GDFT group was conducted by a Vigileo/FloTrac monitor with cardiac index (CI), stroke volume variation (SVV), and mean arterial pressure (MAP). For all patients, demographic data, intraoperative parameters and postoperative outcomes were recorded.ResultsPatients in the GDFT group received significantly less crystalloids fluid (1111 ± 442.9 ml vs 1411 ± 412.6 ml; p < 0.001) and produced significantly less urine output (200 ml [150-300] vs 400 ml [290-500]; p < 0.001) as compared to the CFT group. Moreover, GDFT was associated with a shorter average time to first flatus (56 ± 14.1 h vs 64 ± 22.3 h; p = 0.002) and oral intake (72 ± 16.9 h vs 85 ± 26.8 h; p = 0.011), as well as a reduction in the rate of postoperative complications (15 (25.0%) vs 29 (48.3%) patients; p = 0.013). However, postoperative hospitalization or hospitalization expenses were similar between groups (p > 0.05).ConclusionsFocused on elderly patients undergoing open gastrointestinal surgery, we found perioperative fluid optimisation may be associated with improvement of bowel function and a lower incidence of postoperative complications.Trial registrationChiCTR, ChiCTR1800018227 . Registered 6 September 2018 - Retrospectively registered.

Project description:BackgroundPerioperative goal-directed therapy (GDT) reduces the risk of renal injury. However, several questions remain unanswered, such as target, kind of patients and surgery, and role of fluids and inotropes. We therefore update a previous analysis, including all studies published in the meanwhile, to clarify the clinical impact of this strategy on acute kidney injury.Main bodyRandomized controlled trials enrolling adult patients undergoing major surgery were considered. GDT was defined as perioperative monitoring and manipulation of hemodynamic parameters to reach normal or supranormal values by fluids alone or with inotropes. Trials comparing the effects of GDT and standard hemodynamic therapy were considered. Primary outcome was acute kidney injury, whichever definition was used. Meta-analytic techniques (analysis software RevMan, version 5.3) were used to combine studies, using random-effect odds ratios (OR) and 95% confidence intervals (CI). Trial sequential analyses were performed including all trials and considering only low risk of bias trials. Sixty-five trials with an overall sample of 9308 patients were included. OR for the development of renal injury was 0.64 (95% CI, 0.62-0.87; p = 0.0003), with no statistical heterogeneity. Trial sequential analyses and sensitivity analysis including studies with low risk of bias confirmed the main results. A significant decrease in renal injury rate was observed in studies that adopted cardiac output and oxygen delivery as hemodynamic target and that used both fluids and inotropes. The postoperative kidney injury rate was significantly lower in trials enrolling "high-risk" patients and major abdominal and orthopedic surgery.Short conclusionThe present meta-analysis suggests that targeting GDT to perioperative systemic oxygen delivery, by means of fluids and inotropes, can be the best way to improve renal perfusion and oxygenation in high-risk patients undergoing major abdominal and orthopedic surgery.

Project description:Study designProspective, randomized, controlled study.PurposeTo determine whether the use of goal-directed fluid therapy (GDT) guided by pulse-pressure variation (PPV) and fluid management protocol can reduce intraoperative hypotension, blood transfusion requirements, and postoperative complications in adults undergoing complex spine surgery.Overview of literatureComplex spine surgeries involve a significant risk of blood loss and intraoperative hypotension. Previous studies showed that GDT reduces intraoperative hypotension and postoperative complications in these surgery types; however, limited information exists about GDT guided by PPV.MethodsSixty adults (18-70 years) patients undergoing complex spine surgeries at Siriraj Hospital, Mahidol University, Thailand were enrolled. Patients were allocated to two groups (30 patients in each) using computer-generated randomization. Intraoperative fluid and vasopressor were administrated via either GDT or standard care. The GDT algorithm used PPV and fluid protocol as the primary tool to guide hemodynamic management. The incidences and episodes of perioperative hypotension were measured as the outcomes.ResultsFifty-seven patients were analyzed (three patients in the GDT group were excluded). The baseline characteristics and surgical procedures of the two groups did not differ significantly. The prevalence of intraoperative hypotension was 80.0% for the control group and 66.7% for the GDT group (p=0.25). Two episodes (1-3) of intraoperative hypotension occurred in the control group, and one episode (0-3) occurred in the GDT group; the difference was not significantly different (p=0.57). The intraoperative blood transfusion requirements and postoperative complications were similar in both the groups. In the subgroup analysis, patients with intraoperative hypotension exhibited a higher incidence of postoperative bowel dysfunction.ConclusionsPPV-guided GDT and fluid protocol, as compared with standard practice, did not show significant advantages with respect to intraoperative hypotension, blood transfusion, or postoperative complications in patients undergoing complex spine surgery in the prone position.

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

Publications

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

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